PROSTATE PROS

PROSTATE PROS Series Finale

On the last episode of the PROSTATE PROS podcast, Dr. Scholz and Liz recap important themes and talk about what’s new in prostate cancer, including Lutetium-177 and Orgovyx.

Dr. Scholz:  [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I'm your host, Dr. Mark Scholz. 

Liz:  [00:09] And I'm your cohost, Liz Graves. 

Dr. Scholz:  [00:13] Welcome to the PROSTATE PROS podcast. 

Liz:  [00:15] We have a bit of a sad announcement to make, as this will be the last episode of the PROSTATE PROS podcast.  Dr. Scholz and I have really enjoyed working on this project and we've covered so many important topics surrounding prostate cancer and men's health.  So for this last episode, we're going to recap some important themes and talk about some promising new therapies.  So Dr. Scholz, on our very first episode, we talked about how important it is to find the right treatment team.  This is something that's come up again and again and again.  What are some tips you have for newly diagnosed men trying to find their doctors? 

Dr. Scholz:  [00:53] I think what's confusing is how much of the responsibility falls on the shoulders of patients.  The prostate industry is a very powerful multi-billion dollar industry, and there is a lot happening really fast.  When patients are diagnosed, they're not in a thoughtful perspective, they're in an action mode, they're frightened.  It is hard to sort out who to listen to and who to stay away from. This process can be aided by family members, primary care doctors, oncologists, and of course, online resources and books.  I try to provide some of that information in the book, The Key to Prostate Cancer, but the process, if it was easy, we could give you one simple answer.  It is not a simple process. 

Liz:  [01:46] One thing that we've talked about is to get a quarterback.  So this is a doctor that isn't the treating doctor necessarily, but it’s someone that will oversee the treatment and work with the other teams of doctors.  This is something I hear you doing Dr. Scholz, you're always talking to other doctors about patients and kind of networking with them to make sure that the patient is getting the best care, even when they're not in our office. 

Dr. Scholz:  [02:12] I think the issue that you're relating to is that many of these physicians have a conflict of interest.  You're asking them, what should I do?  But they're a surgeon or they're a radiation doctor.  And as a medical oncologist, I'm neither of the above.  This is somewhat uncommon, but you can recruit your urologist or your radiation doctor to help you by explaining at the outset that, “you, sir, will not be my treating doctor, but I definitely need your aid and your assistance in picking the right doctor.” 

Liz:  [02:43] Now you may be thinking that you have cancer and you don't have time to see all these people, but as we've mentioned, prostate cancer is slow growing.  So really taking that time to find the right doctor for you is crucial. 

Dr. Scholz:  [02:56] Just yesterday, I saw a very sophisticated new patient who was feeling the rush job, the sense that the clock is ticking, and he did have a Gleason 9.  We consider that the High-Risk category of prostate cancer.  But, the idea that you have to make a decision within days or weeks is never substantiated by the literature and the science.  Patients can take several months to sort out what they want to do.  This sort of careful thoughtful process pays off in the long-term with better results. 

Liz:  [03:29] So patients really need to take it under their control.  One of the things is to educate themselves.  In the past couple of years, there's been a huge shift towards imaging.  So we've had the approval of the PSMA PET scan and using 3T MP MRIs and color Doppler to help men diagnose their prostate cancer and watch it. 

Dr. Scholz:  [03:51] What Elizabeth is referring to is that if you don't have a clear picture of where the cancer is and whether it's spread outside the gland, what part of the gland it's located in, it's not feasible to tailor treatment to the specific needs of the individual.  Some men are fortunate enough to have prostate cancers residing on one side of their gland.  This opens the door to something called focal therapy, enabling men to undergo treatment with less risk of erectile dysfunction.  There were a lot of things we could have covered in this last podcast and the reminder that quality imaging and not only MRI and PSMA PET scans, but scans done at centers of excellence that are read by experts are going to help men be light years ahead in their selection of treatment, because they'll have a clear picture of what they're really treating. 

Liz:  [04:43] So we've actually gotten emails from people all across the country saying, you know, my doctor's never heard of the PSMA PET scan or my doctor doesn't do 3T imaging.  So it is really important that you take the time to educate yourself and bring these questions to your doctors.  Finding the right treatment team and doing your due diligence to make sure you're choosing the right treatment is all important because of where the prostate is located.  Treatment related side effects can have damaging effects on quality of life.  Because prostate cancer is so slow growing, hopefully you'll have a very long life, so it's important that that can be lived to the best of your ability. 

Dr. Scholz:  [05:25] That's so, so important.  And these functions, sexual, urinary functions are something that people face every day of their life.  In the hustle bustle to get treatment quickly, the fact that if the treatment is not done in an ideal way, that men can be left with permanent issues unnecessarily, certainly if there was no other option, we would live with these negative consequences. But, in most cases now with skillful care, these things can be avoided.

Liz:  [05:58] Over the past two years, Dr. Scholz and I have covered all the treatment options from active surveillance to surgery, radiation chemotherapy.  These episodes will still be available even after the podcast ends, you can go back and re-listen and keep sharing with friends and educating yourself. 

Dr. Scholz:  [06:16] One thing about this information provided in the podcast is not only the idea of which treatment is best and what kind of things to look out for, but the step by step process, the thinking process, the procedures, and how you can come to get the right doctors and the right treatment is implicit in the whole podcast system that we have provided.  So you can also just learn from the thought process that leads to successful outcomes. 

Liz:  [06:49] While there are a lot of challenges that newly diagnosed patients face, patients with advanced prostate cancer also are missing out on some tools like Xgeva and Prolia. 

Dr. Scholz:  [07:01] These medicines are to help compensate for men who have disease that’s spread to their bones or men who've been on hormone treatment and the calcium is leaching out, a process called osteoporosis.  The number of times this is overlooked and people coming to us for second opinions is really quite surprising, as they are FDA approved to help compensate for these problems.  So simple second opinions can be so valuable for men, even if they have advanced disease. 

Liz:  [07:35] As we segue into what's coming up and what's new in prostate cancer, we wanted to quickly mention that there are a lot of new drugs and things being tested for FDA approval through clinical trials.  Clinical trials are a great way to get access to these new medications, if you have a specialist on your team who is constantly looking out for these and keeping tabs on what's coming up.

Dr. Scholz:  [08:03] Every new medicine or treatment goes through a process of being researched. Once it's validated as a treatment, it gets FDA approved.  And then after that, it becomes commercialized and broadly available across the country.  The things that succeed through that process are very valuable.  And we'll be talking about a Lutetium-177 and a new pill called Orgovyx.  These medicines have been available, but now are commercially available.  If your physician is not staying abreast of all the new developments, men who could benefit from these treatments will be denied access simply through unawareness. 

Liz:  [08:43] Lutetium-177 is something that we've talked about on past podcasts.  And it's not even FDA approved yet, but you've actually had some patients who have had it, is that correct? 

Dr. Scholz:  [08:57] Lutetium-177 a was purchased by a Novartis pharmaceuticals for $2 billion prior to all the testing being completed because all the preliminary data looks so favorable recently, they released the code for the large clinical trial that was performed confirming that it does prolong survival. This is a medicine that was evaluated in men with very advanced prostate cancer who had already had chemotherapy who had been on other powerful hormone treatments and they'd stopped working.  The man who got treated with Lutetium-177 lived longer, statistically significantly longer, than the men who got an alternative, placebo-type approach.  This medicine is well tolerated.  It can cause some dryness of people's mouths.  It can lower blood counts a little bit, but it's a simple injection every six weeks.  And it is a potent treatment for men with advanced disease.  It may even be a useful treatment for men with earlier stage disease.  This will probably be commercially available within a year. 

Liz:  [10:05] To learn more about this medicine, we covered it in Episode 10, Don't Reject Radiation.  So you can go back and listen to that.  At the end of 2020, there was a new FDA approval Orgovyx.  This is an oral anti-androgen, so it works kind of like a Lupron, but instead of it being an injection, it's just a daily pill. 

Dr. Scholz:  [10:28] So how much do we really need a new pill?  When if you could take an injection that lasts three to six months, and you don't have to remember taking pills every day, but Orgovyx may have some other advantages when compared to head to head with Lupron and the other medicines like Lupron, such as Firmagon and Trelstar, Eligard, and Zoladex.  These medicines all work by shutting down the production of testosterone in a man's testicles.  Orgovyx is interesting for two reasons.  One is that the recovery of testosterone when treatment is stopped, seems to be much more predictable and consistent medicines like Lupron, and the others that I mentioned, can have a very protracted and prolonged effect even after they're stopped, and it's hard to predict when testosterone is going to return.  Another thing that came out in Orgovyx trials was a lower incidence of cardiovascular complications.  For years, I've made a strong argument that Lupron and other drugs do not cause cardiovascular problems directly, but indirectly in men who have a lot of weight gain, blood pressure goes up, blood sugars start to go out of control.  Of course these things can lead to cardiovascular problems, but for some reason, in that randomized trial Orgovyx had a lower incidence of cardiovascular related issues.  This is certainly an interesting and potential advantage for this medication.

Liz:  [11:56] Technology and medicine around prostate cancer is improving almost daily.  And one of the things that's really promising is immunotherapy.  We talked about this on Episode 9, The Intelligence of Immunotherapy, and we cover all sorts of different things that will benefit men with prostate cancer, like KEYTRUDA and OPDIVO YERVOY.  So if you're interested in learning more about immunotherapy Episode 9 is a great place to start.  Making this podcast has been such a rewarding experience for Dr. Scholz and I, and we really hope that it's helped you on your prostate cancer journey.  And we've left you with a little more education and knowledge and empowered you to take control of your prostate cancer diagnosis and spend time really learning about it and understanding, so you can have your medicine personalized to you.  You can find the right doctors, seek second opinions, and then take everything you've learned to spread awareness about prostate cancer.  Remember prostate cancer is a silent disease and it affects so many men and families and loved ones.  This really needs to be something that people are comfortable talking about.  So we hope our podcast has helped give you some points to talk about with your friends and family members and help them make those treatment decisions.  

Dr. Scholz:  [13:26] So Kaili, my business manager and myself are very grateful to Liz for all the hard work she's done in compiling these episodes and helping us reach the things that really count.  It's been quite a bit of work along the way, which has been a delight to participate in for me.  Liz, can you just share a couple of sentences of where you think you're going to be going with your own professional career as you're moving on? 

Liz: [13:51] Yes.  I am actually pursuing higher education to become a professional writer.  I am looking forward to it, but I'm definitely sad that I won't be working with you and bringing this podcast to everyone.  I know I've had so much fun learning about prostate cancer and hopefully being able to help all of our listeners navigate this subject.  Again, these episodes have been archived, so you can go back and listen to all twenty-four of them on podcast.prostateoncology.com, or Apple Podcasts, SoundCloud, wherever you like to listen.  Another good tip is that the PCRI’s YouTube videos come out every week.  These are awesome videos that talk all about prostate cancer.  Dr. Scholz is a very frequent guest on there, so I would highly recommend you check that out.  You can find them at youtube.com/thePCRI.  Thank you for listening and supporting us.

For decades the random 12-core biopsy has been the standard of care for diagnosing prostate cancer. What most men don’t know is that random biopsy can be dangerous and its results misleading. Fortunately, there are now better ways to interpret a high PSA that are less invasive, safer, and more accurate. The tragedy is many men don’t know this. One million men continue to get random biopsies each year despite having better options.

This episode discusses the dangers of random biopsy and the best steps to take when facing an elevated PSA. If you’ve already been diagnosed with prostate cancer, share this episode with your friends and family! There are better, safer ways to interpret high PSA.

Dr. Scholz:  [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I'm your host, Dr. Mark Scholz.

Liz:  [00:09] And I'm your cohost, Liz Graves.

Dr. Scholz:  [00:13] Welcome to the PROSTATE PROS podcast.

Liz:  [00:16] A lot of our listeners are men who already have prostate cancer.  This episode is for those people's friends who have a high PSA and are wondering what to do.  Do they get a random biopsy?  Is that dangerous?  Are there any alternatives? 

Dr. Scholz:  [00:32] Yeah, Liz, I come across this all the time after I have a face-to-face meeting with one of our patients and we're helping them with their prostate cancer.  They mention “Oh, by the way, my friend Sam called me up and his PSA is running high, and his urologist wants to do a 12-core biopsy.  Can I run his case by you, Dr. Scholz?”  

Liz:  [00:52] This episode, Dr. Scholz and I are going to talk through some easy points that you can share with men going through this, and we'll also post a flow chart on our blog, prostateoncology.com/blog.

Dr. Scholz:  [01:06] One thing that really motivates us is the concern that too many men are getting random 12-core biopsies.  We've talked before about the wonderful advances in imaging for prostate imaging that have been developed over the last few years.  If 12-core biopsies were harmless, they certainly provide accurate, useful information, but they can cause complications.  Imaging is actually more accurate.  Unfortunately, the industry is sort of stuck in the past and 12-core biopsies are still being done with great frequency.  Hopefully we can give you some idea of when this may or may not be indicated. 

Liz:  [01:47] Yeah, this is one of those things in prostate cancer, where there are better options, but men are really just hearing about random biopsy.  It's the option most people get.  Almost everyone knows someone who has had a random biopsy.  There are about a million of these done each year, so it's kind of public knowledge that when you get a PSA, you'll likely get a random biopsy. 

Dr. Scholz:  [02:10] It's been this way for historical reasons.  The random biopsy was a big breakthrough in 1987.  It was approved the same year PSA came on the market.  So when the PSA was high, everyone would get a 12-core, round-the-clock, needle sticking in their prostate.  Really there was no other alternative because imaging for so many years, really wasn't adequate to see prostate cancer inside the prostate. 

Liz:  [02:38] When you're comparing this to a different type of cancer, let's say liver cancer, they're not just taking random samples of the liver.   Are they expecting that there'll be imaging?  And why is the prostate something that's handled so differently? 

Dr. Scholz:  [02:54] I think it's because historically the cancers that come from the prostate, aren't very malignant, thank God, and they tend to have a similar background appearance to the prostate gland itself.  So, very specialized techniques had to be developed for the cancers to light up to an adequate degree, to be visible on these scans. 

Liz:  [03:15] Before we get into imaging, let's address some of the risks of random biopsy.  The first risk is something that I know you're very passionate about and actually wrote The Invasion of the Prostate Snatchers about, and that's the over-diagnosis of low-grade cancer.  These are the Gleason 6 cancers. 

Dr. Scholz:  [03:33] We now know that Gleason 6 cancers don't spread and to call them cancers is an egregious overstatement.  They still do call it cancer however, and this creates confusion.  It's really better for men if this isn't diagnosed.  It doesn't spread and it doesn't need treatment.  12-core biopsies are much more likely to find Gleason 6 cancers than an image guided biopsy.  This is one excellent reason to avoid a 12-core biopsy. 

Liz:  [04:07] This is something that we're kind of in an uphill battle against.  You said that Gleason 6 cancer doesn't need to be diagnosed.  And I think a lot of men think, well, if I have cancer, don't I want to know about it?

Dr. Scholz:  [04:20] Yeah.  Not only do men think they should know about it, but they think they should be treated for it.  Cancer is an action word.  And the idea of sitting quietly and doing nothing with a cancer seems totally ridiculous.  It's the problem with the naming of this entity, which really isn't a cancer, but it's called a cancer.  The best analogy I've ever come up with is the difference between melanoma and squamous cell carcinoma of the skin.  The melanomas are the type of cancers that can spread, and the squamous cells stay put and don't spread, yet they're both called cancers. 

Liz:  [04:56] So a biopsy can diagnose men with Gleason 6 prostate cancer, and then they'll rush into treatment.  They'll get surgery, they'll have terrible side effects that will be lifelong.  So it's really dangerous to be over-diagnosed with a low-grade cancer. 

Dr. Scholz:  [05:11] Yeah, really, if there was no other option, we'd keep quiet about random biopsies.  I saw a patient just yesterday in the office; a sweet eighty-five year old man came to me because his urologist wanted to do another biopsy.  His PSA is running high, around 10, and his 20-core biopsy that was done in 2018 caused him to bleed three and a half units of blood.  How frightening!  If it was necessary to take these risks, one can certainly understand doing another biopsy, but imaging, now we know, is much better. 

Liz:  [05:49] Beyond over-diagnosis, biopsies are dangerous.  There's a risk of infection, erectile dysfunction, rectal bleeding. The list goes on.  But I think a lot of patients don't have this conversation with their urologists or if they do, they think it's just kind of what needs to happen to figure out the cause of their PSA. 

Dr. Scholz:  [06:11] I mentioned a patient who had a bleeding problem, but the real fear is that 1% of the time men develop infections that are so serious that they have to go to the hospital.   For otherwise healthy men to be hospitalized with really life-threatening infections is a tragedy.  When we know we have other approaches that can be just as effective, or even more effective than doing a biopsy. 

Liz:  [06:34] The other thing too, as we talked about in the last episode, PSA can be from multiple different things, including just a big prostate.  So sometimes men with big prostates will have biopsy after biopsy and they're not finding cancer, but their PSA's are still high. 

Dr. Scholz:  [06:52] This becomes more common in the men with larger prostates.  So a man with a very small prostate that has multiple needles stuck into his gland is most likely going to get a good, clear sampling.  But doctors know that with big prostates, sometimes they have to do more and more biopsies to get a good chance at finding all the cancers. 

Liz:  [07:13] A 1% infection rate may not seem that big, but considering that one million men get prostate biopsies each year, that means about ten thousand men are going to the hospital with infection. Random biopsies can also miss high-grade cancer.  This happens about 20% of the time. 

Dr. Scholz:  [07:32] So the first step to consider is a blood test called OPKO 4K.  This test is more useful than PSA because it clues the doctors in when there's a higher grade cancer present, a Gleason 7 or above.  Unfortunately it's not a perfect test.  It gives a percentage likelihood that a higher grade cancer is lurking in the gland.  This is certainly useful, if the percentage is very low, say less than 5% likely such individuals could consider then skipping doing a biopsy and just continuing on their PSA monitoring. 

Liz:  [08:09] So a lot of our listeners may have experienced random biopsies and obviously they're uncomfortable.  They're dangerous, and they're not necessarily something you'd want to tell your friend to go do.  So what are some options that men with high PSAs have that allow them to avoid the random biopsy, but still get accurate results and understand their PSA? 

Dr. Scholz:  [08:35] Yeah.  This is really the big breakthrough for over the last few years.  The imaging in particular with a multiparametric MRI is truly more accurate than a biopsy and studies have proven this.  Of course MRIs are non-invasive.  If an MRI shows a spot it's graded from 1 to 5 on a system called the PI-RADS system.  If the spot is graded a PI-RADS 4 or 5, some doctors say level 3, then a targeted biopsy to see what's in the spot is necessary.  So in certain situations you can't avoid doing a biopsy, but a targeted biopsy would involve possibly two or three biopsy cores rather than a dozen or more cores. 

Liz:  [09:21] In our office, OPKO 4K is the most used, but there are competitors like SelectMDx and ExoDx, which do kind of the same thing.  So the OPKO 4K report will come back and it will give a percent likelihood that you have a Gleason 7 or higher prostate cancer.  If the likelihood of having one of these consequential cancers is low, patients should go back to annual PSA monitoring.  If the likelihood is high, patients should consider getting scanned with an MRI or a color Doppler ultrasound.  So before we get into targeted biopsies, I wanted to mention that it's very important about where you're getting your MRIs done.  These can be tricky things to read and tricky things to perform, so going to a center of excellence will give you the best results. 

Dr. Scholz:  [10:14] Yes, in fact, if patients bring MRI reports to my office for interpretation, and I don't recognize the place where the MRI was done, I routinely asked for those images on a disc and forward them to a center of excellence like UCLA, Cornell, UCF, and have the images over read by a valid expert. 

Liz:  [10:36] Where does the color Doppler ultrasound fit into this? 

Dr. Scholz:  [10:41] Not very many doctors see enough patients to get skillful with color Doppler ultrasound.  We, however, find it very handy because it's a simple office procedure and it gives us information as to whether there is a suspicious area on the gland, just as the MRI does.  It also tells us how big the prostate gland is, which allows us to get a sense of why the PSA might be elevated.  For example, if the prostate is particularly large and the PSA is only minimally elevated, it's quite likely that the high PSA is merely from the big prostate, rather than coming from a cancer.

Liz:  [11:19] Just as it's important for people to get scanning at centers of excellence, it's also important to note that targeted biopsies require that same level of expertise. 

Dr. Scholz:  [11:31] Another thing to be aware of is that a lot of the doctors that are doing so-called targeted biopsies don't trust their skills.  Sometimes they don't trust the MRIs that they're looking at, and they feel obligated to do a random biopsy on top of a targeted biopsy.  In fact, that's almost routine.  Those of you that are seeking a targeted biopsy need to have this discussion before you're on the table in that vulnerable position, and the doctor starts hammering away with biopsy after biopsy.  I personally would express clearly to my physician, prior to the biopsy, that I only want a targeted biopsy and to not include the random portion. 

Liz:  [12:11] So we're starting with something nonspecific, which is the PSA test.  Then we're using tests like the OPKO 4K, like MRIs, and targeted biopsies to figure out where that high PSA is coming from. 

Dr. Scholz:  [12:25] What Liz says is exactly right.  The ambiguity of PSA creates a real challenge as to what the next step should be, and people need to be patient with themselves, even with the doctors.  Technology is changing quickly and some doctors get on board early with things, others don't.  We're looking to these physicians as our authority figures, and some of them are still kind of locked in the past. So the take-home message here is to go slow, do your research, talk to a lot of people, and familiarize yourself.   Thank God that prostate cancer is a very slow process, and of course it may not even be present, that is to be determined, but the go slow approach is essential in this whole process of figuring out what to do with a high PSA. 

Liz:  [13:21] This can all seem overwhelming and confusing, especially during a time that can be filled with fear and experiencing a lot of different pressures, so we've posted a flow chart of PSA screening on our blog.  You can find it at prostateoncology.com/blog.  Before we close, we wanted to address some listener questions we got from our last episode “The Brief on PSA.”  We had a listener email this question in: “What is the difference between a standard PSA test and an ultrasensitive PSA test?”

Dr. Scholz:  [14:02] When you're reading a PSA on a report, you'll notice sometimes that (this is only relevant when the PSA is very low) the numbers to the right of the decimal point may read 0.1 or in another report, it might read 0.11, or even in a more ultrasensitive report, 0.111, three digits to the right, indicating very small changes can be measured with what are called ultrasensitive PSAs.  So in men who have had previous surgery and their PSA should be undetectable, ultrasensitive PSA can detect a recurrence at an earlier stage than other technologies can.  Ultrasensitive PSA should be used in almost all cases.   For men with higher PSAs, say above 1 or 2, it's really not that important whether the PSA has ultrasensitive technology or not. 

Liz:  [15:05] So besides standard PSA and ultrasensitive PSA, another listener was curious if there are other types of PSA tests and which of these are the most beneficial?  

Dr. Scholz:  [15:17] There are actually quite a few there's something called free PSA or percent free PSA. There’s something called complexed PSA.  These have all been attempts to try and further refine the question that I believe OPKO 4K answers best.  They’re trying to sniff out which individuals with high PSA have a consequential type of prostate cancer that is a cancer that has a Gleason score of 7 or higher.  The complexed PSA, the percent free PSA had some utility, but it's not as useful as OPKO 4K, or perhaps the SelectMDx that Elizabeth mentioned earlier, or the ExoDx test.  So these other PSAs, which are available are just giving you the same information that any old PSA provides. 

Liz:  [16:07] So when a patient comes to our office, Dr. Scholz isn’t ordering five different types of PSA, he just uses the ultrasensitive PSA test.  Thank you for sending your questions.  If you have further questions, please send them to [email protected].  Thank you for listening.  Please remember to rate, review, and subscribe on Apple Podcasts.

PSA (prostate-specific antigen) is essential for prostate cancer screening and monitoring. This episode explores the PSA controversy, explains why annual PSA screening is crucial, and talks about the importance of PSA testing for monitoring prostate cancer treatment. Understand the benefits and drawbacks of PSA, and use this incredible tool to your advantage.

Dr. Scholz:  [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I'm your host, Dr. Mark Scholz. 

Liz:  [00:10] And I’m your cohost, Liz Graves.

Dr. Scholz:  [00:13] Welcome to the PROSTATE PROS podcast.

Al Roker:  [00:16] I've been feeling great, but my doctor discovered I had an elevated PSA level in my blood work, PSA standing for prostate-specific antigen.  It's the first line of defense when detecting possible prostate cancer.

Dr. John Torres:  [00:32] Today, an influential medical task force is changing those screening guidelines.  Now, urging all men ages fifty-five to sixty-nine to talk to their doctor about getting a PSA test.  Men ages seventy and older should not get screened.

Dr. Kirsten Bibbins-Domingo:  [00:46] This should really be a personal choice that a man makes together with his doctor, and the goal of these conversations is really to understand benefits and harms.

Dr. John Torres:  [00:57] Previously experts… 

Liz:  [00:58] There's a lot of confusion and hesitation surrounding PSA screening.  What are the proper steps?  What do you do if the PSA test does come back abnormal?  This episode, Dr. Scholz and I are going to talk about the importance of PSA testing, what a high PSA actually means, and what the best steps to take are to further investigate.

Dr. Scholz:  [01:21] The PSA blood test has been around since 1987, about the time my career started it up.  I can't tell you how revolutionary this blood test has been.  Really, we don't have another blood test like this for other cancers.  In some ways, PSA makes prostate cancer a much easier cancer to treat.  In other ways, like any powerful tool, if it's misused, it can create confusion and problems.  I hope we'll be able to bring some clarity to why this blood test can be controversial. 

Liz:  [01:57] Everyone knows that PSA tests for prostate cancer.  PSA stands for prostate-specific antigen.  And when this is screened annually in men, it is to look for prostate cancer, but that is not all that PSA does.

Dr. Scholz:  [02:15] The problem with PSA as a screening tool and PSA is used for other things besides screening.  But, as a screening tool, men still have a prostate gland.  Typically if they have a small tumor in their prostate, the lion's share of the PSA is actually coming from the gland, the benign prostate, not the cancer.  This is where the confusion comes.  Men will have inflammation of their prostates, and the PSA will be high.  Men will have enlarged prostates, and their PSA will be high.  Or, of course, they could have a low-grade, or a more consequential cancer, and their PSA could be high.  One savvy patient once told me, tell your patients to think of the PSA as a check engine light on the dashboard of your car.  Something's going on in the prostate, it could be cancer, and it could be one of these other causes. 

Liz:  [03:12] When a PSA comes back elevated, taking time to understand what that means is crucial.  PSA can be a great tool to tell people they have prostate cancer, but it also has all of these other possible complications.  In 2011, the US Task Force advised against PSA testing.  Why was this Dr. Scholz?

Dr. Scholz:  [03:35] Small cancers that don't spread are the root difficulty we have.  There have been active discussions about renaming certain types of prostate cancer as something non-cancerous.  That would be appropriate.  Of the 200,000 men diagnosed every year, about 100,000 have a condition that was named cancer back in the 1960s, that we now know never spreads.  But, that word cancer is so motivating that many people, to this day, are rushing into unnecessary surgery and radiation.  So the Task Force, realizing this problem of overtreatment, thought that quite possibly PSA screening was causing more harm than good.  Men were having treatments, making them impotent and incontinent for a condition that would never hurt them.  They later realized in 2016 that the men who have high-grade cancers were getting a short end of the stick.  People were coming in with more advanced cancers.  So they rescinded their recommendation to forgo PSA screening.  But you can imagine what confusion has ensued when you have a large task force arguing for, or against this powerful and useful test.

Liz:  [04:54] Low-grade cancers, which are also called Gleason 6, never spread.  So this PSA testing can lead to unnecessary treatment.  So there's been a lot of controversy about the PSA testing.  What's your policy, Dr. Scholz? 

Dr. Scholz:  [05:10] Well, I'm a big believer in doing PSA testing, at least in patients who are informed.  I get concerned about PSA testing just as the Task Force got concerned.  If you have uninformed patients that are like sheep, just doing what the industry tells them to do, those men are at risk of getting unnecessary surgery and radiation, which has all the consequences we mentioned. 

Liz:  [05:34] This is something we come back to again and again, it's how important it is to advocate for yourself.  This means educating yourself, this means having conversations with doctors.  PSA screening should begin at forty for people who have family history and at forty-five for people who do not.  

Dr. Scholz:  [05:54] Be aware that when you go in for an annual physical, many of you are assuming that your doctor's simply going to add a PSA to the blood test section that isn't always happening.  Some doctors still are following the 2011 Task Force recommendations, and it doesn't come up in conversation.  I have seen patients come in with high PSA, say from an insurance exam, and when they look back at their annual physicals, their doctor wasn't doing PSA.  So you need to make sure that PSA is part of the blood screening during the annual physical. 

Liz:  [06:31] What happens if someone isn't getting annual PSA tests? 

Dr. Scholz:  [06:35] Well, hopefully they don't have a bad prostate cancer, in which case they'll be fine.  But the incidence of prostate cancer is somewhere around one in seven men.  This means that a significant number of men could end up with advanced cancers that could have been prevented. 

Liz:  [06:52] When most people think about PSA, they attribute it with screening.  Men with prostate cancer know that PSA is used for more than just screening. 

Dr. Scholz:  [07:03] So when we were naming our clinic, Prostate Oncology Specialists, we actually considered calling ourselves the PSA clinic.  PSA for men who have already been diagnosed with prostate cancers is a very accurate test.  Why is this?  Well, as I stated before, one of the problems we have with screening is that men's prostate glands are intact.  The prostate gland makes a lot of PSA, which is unrelated to cancer.  Most men that have been treated for prostate cancer have had their prostates, either surgically removed or they've undergone radiation, which dramatically reduces the amount of PSA production from the gland.  So, if we are monitoring someone going forward who's been previously treated, if the PSA starts going up, we know that it's almost certainly coming directly from the cancer.  It gives us a speedometer to tell us how much cancer is present and how fast it's growing, which we can tell by how quickly it rises. 

Liz:  [08:03] So, men with prostate cancer will get very familiar with their PSA numbers because they're being monitored, they're being discussed in terms of treatment options and staging. 

Dr. Scholz:  [08:14] Many of my medical oncology colleagues are very jealous when I tell them that I specialize just in prostate cancer because of the accuracy of the PSA test.  We don't have as much ambiguity about the status of the cancer.  We can tell so much about how the cancer is behaving just by checking a PSA. 

Liz:  [08:35] How often are men with prostate cancer having their PSA's checked during monitoring? 

Dr. Scholz:  [08:41] Well, they’re certainly different situations.  The men who've had surgery or radiation typically will get their PSA checked every three months for a couple of years after the treatment, then maybe every six months out to about five years after treatment, then annually thereafter.  Men with advanced cancers, who are undergoing hormone treatments or chemo treatments, will often have their PSA checked every month to determine how effective the treatment is.  Is it working and whatnot, because we want to know if we need to switch treatment or strengthen or reduce the intensity of the treatment. 

Liz:  [09:18] PSA is a great tool for men with prostate cancer, whether it be for screening or for gauging treatment success.  There is so much to learn about PSA screening, DREs, OPKO 4K.  We've discussed this in past podcasts, but we'll always keep you updated on what the latest is on these topics.  For those of you who love to learn about prostate cancer, the Mid-Year Moyad and Scholz Update with the PCRI is on Saturday, March 27th.  It's free registration and it's virtual this year.  So we're really looking forward to joining in on that.  You can register at pcri.org and submit any questions to the experts.  This year Dr. Tia Higano will be joining, she is a brilliant oncologist from the University of Washington.  She will be talking about hormone therapy and its side effects.  The new PSMA scan will also be talked about by Thomas Hope.   Dr. Scholz, what are you looking forward to with the PCRI Mid-Year Conference? 

Dr. Scholz:  [10:28] Both the topics are so relevant, but the new PSMA PET scans, which we've talked about extensively really can't be talked about enough.  They're going to have relevance for men with advanced disease and men who are dealing with early stage disease.  This information is going to be very helpful, but it is so new, I don't even know all the things that are going to be coming. 

Liz:  [10:52] My personal favorite part is always when you and Dr. Moyad talk.  So I'm looking forward to hearing some great questions and seeing what you have to say.  Thank you for listening.  You can email any questions or topics to [email protected].

Prostatitis is inflammation of the prostate gland that can affect PSA and cause symptoms such as urinary frequency and urgency, fever, and pelvic pain. Prostatitis can be difficult to identify and hard to treat. This episode discusses diagnosing prostatitis, treating prostatitis, and how it can affect prostate cancer treatment decisions.

Dr. Scholz:  [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I'm your host, Dr. Mark Scholz.

Liz:  [00:09] And I'm your cohost, Liz Graves. 

Dr. Scholz:  [00:13] Welcome to the PROSTATE PROS podcast. 

Liz:  [00:16] Prostatitis is inflammation of the prostate, which can have a huge negative impact on quality of life.  This episode, we're going to talk about diagnosing prostatitis, treating prostatitis, and how it can affect prostate cancer treatment decisions. 

Dr. Scholz:  [00:31] The real reason this topic comes up is because PSA goes up in men that have inflammation in their prostate, which is what we're calling prostatitis.  There are many causes, we're going to go into that, but the confusing factor is that we're using PSA to diagnose prostate cancer, to monitor prostate cancer for treatment effect, and for relapse.  If inflammation in the prostate intervenes and causes the PSA to go up, everyone gets frightened about the possibility of prostate cancer being out of control.  So this podcast will cover trying to make a distinction between a high PSA from prostatitis and a high PSA from prostate cancer. 

Liz:  [01:17] So prostatitis is inflammation of the prostate, and there can actually be no known cause of this, or it can be due to bacterial infection and it can also manifest in many different ways. 

Dr. Scholz:  [01:31] There's so much confusion about what really is prostatitis.  It may be sort of an autoimmune phenomenon, the way people get asthma or eczema on their skin, some sort of over activity of the immune system, but it's quite common and it's often asymptomatic.  So that means that the PSA goes up, but men may not be feeling any urinary irritation.  At the other end of the spectrum, of course you have the people that have real discomfort and pain with urination and are getting up at night a lot.  When men have these symptoms, it doesn't necessarily mean that it is prostatitis, it could be a large prostate, it could be an irritable bladder, it could be a urinary tract infection, but prostatitis certainly is on the list of possibilities. 

Liz:  [02:19] So you mentioned asymptomatic prostatitis, which still has an effect on PSA.  Can you distinguish a rise in PSA from prostatitis from a rise from prostate cancer? 

Dr. Scholz:  [02:32] Actually, PSA is very nonspecific.  So when we see a PSA rise, we have to start doing all kinds of tests.  The most popular one in the community of course, is to do a prostate biopsy. Our policy has been to do MRI testing, and there are certain blood tests and urine tests like OPKO 4K and SelectMDx that can help sniff out whether prostate cancer is really the problem.  But many times, we are left with an ambiguous situation; an elevated PSA without a clear cause.  And that's when people start calling it prostatitis. 

Liz:  [03:12] For people who do have symptoms, there are two or three different types. There's acute bacterial, chronic bacterial, and chronic prostatitis. 

Dr. Scholz:  [03:23] Years past when this problem was encountered, the reflex reaction was just to give some antibiotics.  If the PSA would drop after a couple of weeks of antibiotics, then it must be prostatitis.  The problem with that is that the antibiotics have potential bad effects.  Secondly, they're not always effective because the many types of prostatitis are not bacterial.  Thirdly, the problem with prostatitis is it usually isn't permanently cured with antibiotics, you get a temporary remission, but then you're back to having to do antibiotics again and again.  Now, these days we don't usually jump on people with antibiotics, but some doctors still like to use this approach. 

Liz:  [04:10] This seems like a difficult condition to manage.  What other medicines, other than antibiotics do you use? 

Dr. Scholz:  [04:18] So sometimes we just wait and keep checking the PSA and the inflammation will tend to die down on its own.  There are things that are popular over the counter products like Saw Palmetto, anti-inflammatories that you can pick up at the pharmacy like Aleve or Advil.  Sometimes a course of anti-inflammatories will cause a PSA decline and encourage us that the underlying problem is related to prostatitis as cancer won't respond to an anti-inflammatory. 

Liz:  [04:52] So if someone goes on anti-inflammatories and their PSA declines, and they just have prostatitis and no prostate cancer, should their PSA be zero?

Dr. Scholz:  [05:03] So men have to always calculate the normal PSA by looking at the size of the prostate.  This is usually determined with an MRI or an ultrasound.  The ten-to-one ratio is that if the prostate's 40 CCS in size, a normal PSA will be around four.  So PSAs will typically run in the one to eight range, but there's so much variability in prostate size.  A normal PSA can vary from individual to individual. 

Liz:  [05:33] PSA is one way to possibly diagnose prostatitis.  What other ways do you figure out that this is the problem? 

Dr. Scholz:  [05:42] Well you mentioned before that there's certain men that get bacterial infections and they're uncomfortable: they have soreness in their pelvis, they have pain with urination.  If it gets out of hand, it can even cause a fever.  So diagnosing prostatitis when there are symptoms like that is really easy.  The problem is that 90% of the time, perhaps the prostatitis is asymptomatic and we're dealing with PSA's running high over periods of time.  This becomes super relevant in men that are on active surveillance because we check PSA frequently in these people and creates real concern that if the PSA is running high, that maybe we're missing some cancer somewhere. 

Liz:  [06:22] So there are a lot of symptoms with prostatitis, but these symptoms can also just occur in regular, healthy, aging men.  Is telling the difference between those two different people difficult?

Dr. Scholz:  [06:36] What you're referring to is the fact that our aging bladder gets more irritable and you can get up at night more frequently, also prostate glands get bigger and create blockage and all kinds of inconveniences related to the urinary tract.  That is a real diagnostic dilemma.  There are all kinds of tests to try and sort out which of these issues are going on like imaging tests and urinary flow tests.  People should usually get a urinary culture and make sure there's no infection.  So these methodologies are all used to try and sort out what is really going on.  After it's all said and done, if we don't have a clear answer, usually the term prostatitis is applied to the situation. 

Liz:  [07:20] Another thing that I've read about is tracking your PSA, and if your PSA is fluctuating pretty frequently, that might be a sign of prostatitis.

Dr. Scholz:  [07:31] Exactly.  Inflammation comes and goes.  It's not a steady, smooth, growth, the way something such as cancer might occur.  So the ups and downs when you have men with PSAs that are running high, that suddenly dropped, we know that PSA levels don't drop in people with cancer.  So that's another strong indication that prostatitis may be the cause of the PSA elevation. 

Liz:  [07:58] Okay, Dr. Scholz, let's say you have someone who is suffering with symptoms and you've tried antibiotics, you've tried anti-inflammatories, and none of it really seems to be providing relief.  What do you do next? 

Dr. Scholz:  [08:12] It's a tough, tough situation.  Consulting an expert is the next step.  Sometimes mild doses of Proscar or Avodart to try and shrink the prostate will have some benefit, but there is no satisfying one treatment for prostatitis.  Some men have to suffer chronically with only partially resolved symptoms.  It's a very controversial area in terms of what proper treatment is because no one treatment is all that satisfying. 

Liz:  [08:46] Some men who are newly diagnosed with prostate cancer also have prostatitis. What kind of treatment options can these men look at that don't inflame the prostate? 

Dr. Scholz:  [08:57] You can go forward with just about any of the common treatments.  This is one potential argument for surgery, because if the inflamed prostate is a big problem, removing it surgically should improve symptoms.  Sadly, that's not universally the case.  Sometimes the discomfort that people are having turned out in retrospect to not be from the prostate and men have operations and still have urinary difficulties and issues. There've been some that have said that radiation shouldn't be done because radiation causes a transient increase in inflammation.  When the prostate gland is radiated, getting people through that tough period three to six to eight weeks after the radiation can be challenging sometimes, but after the radiation starts to grab hold, the prostatitis symptoms oftentimes will become less and less over time.  Hormone therapy will typically improve urinary symptoms in some men and others, for reasons we don't know, it seems to make the problem worse.  When I'm talking about the problem, I'm talking about people waking up at night or having to urinate frequently.  When I first started giving hormone therapy to men with prostate cancer, my hope was that since we're shrinking the prostate that urinary symptoms would universally improve, but that's not always the case. Why that is, is not clearly understood.  There's a lot going on in the prostate with all these symptoms that we'd still don't completely understand. 

Liz:  [10:26] One interesting thing about radiation is that a couple months after the radiation or even up to a few years, you can have a delayed PSA bounce that isn't cancerous, but it's due to inflammation of the prostate. 

Dr. Scholz:  [10:42] It is frequent and this is more frequent in people that have seed implant radiation, so-called brachytherapy.  You're absolutely correct, people can have a normal PSA after radiation and everything’s looking fine with a PSA less than one.  Then, all of a sudden, the PSA is rising up to two, three, or four.  The suspicion, of course, is that the cancer is coming back.  In the old days, which really means just last year, we had to just sit this out and hope that it would go away and watch the PSA go up and reassure people that this type of thing can happen and maybe it isn't cancer.  With these new PSMA PET scans, which are very accurate, we can have people get scanned when their PSA goes above one to detect if there is any cancer causing a problem and make that distinction between delayed PSA inflammation from radiation induced prostatitis, the so-called PSA bump, versus the cancer having a recurrence. 

Liz:  [11:45] You mentioned this is a really frequent occurrence.  When PSAs go up, patients really tend to panic.  How do you talk about this with them? 

Dr. Scholz:  [11:55] Well, it is a common enough thing that there's plenty of research out there showing that oftentimes a PSA would go right back down after a few months, two to six months, and remain low for the rest of their lives.  Unfortunately, I've seen patients treated perhaps by doctors that don't see as much prostate cancer where they assume that it's a relapse and put them on hormone therapy.  Hormone therapy will always cause the PSA to go down.  This validates the idea that there was a cancer that now is under treatment.  This is a really tragic thing because hormone therapy has a lot of side effects and it certainly shouldn't be used to treat a PSA bump.

Liz:  [12:39] After radiation, the policy is to get PSA tested every three months for two years, then every six months for three years, and annually after that.  If the PSA rises over 0.5, you should get the new PSMA PET scan. 

Dr. Scholz:  [12:58] That's right, Liz, this technology to finally be able to sort out whether it's a PSA bump or a cancer recurrence is incredibly valuable. 

Liz:  [13:08] Prostatitis is a really ambiguous situation and a lot of men have symptoms.  Googling symptoms can lead to men believing they're from prostate cancer.  However, localized prostate cancer never has symptoms, so it's clear these symptoms are from some other condition. 

Dr. Scholz:  [13:28] Exactly right.  So often we were unable to use the word never in the world of treating humans.  You know, we said, well, there's one of this and one of that, but it really is almost universally true that early stage prostate cancer is free of symptoms.  People that have an ache here or a pain there and they're newly diagnosed with a PSA in the 10 to 20 range, they're wondering if their cancer has spread, should be greatly reassured that it's almost impossible for prostate cancer to cause any symptoms at these early stages.  However, prostatitis and other issues are very common.  They certainly do cause symptoms.  Thankfully prostatitis doesn't turn into cancer.  They are separate problems and one causes symptoms and the other doesn’t.    

Liz:  [14:19] This is a great reminder to take things slow when you get back a high PSA.  In a future episode, we're going to talk about men who haven't been diagnosed with prostate cancer, but who have high PSAs and what the next steps are they should take.  Thank you for listening, email questions or topics to [email protected].  Remember to help us out by rating, reviewing and subscribing on Apple Podcasts.

Clinical trials are the basis of modern medicine.  Through a series of phases, clinical trials strive to find more effective treatments with fewer side effects.  For men with limited options, clinical trials can be a great way to access the newest treatments; however, choosing the right clinical trial can be difficult.  This episode discusses pros and cons of participation, how patients can benefit, and addresses some common concerns and misconceptions. 

Dr. Scholz:      [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I’m your host, Dr. Mark Scholz.   

Liz:      [00:09] And I'm your cohost, Liz Graves. 

Dr. Scholz:      [00:13] Welcome to the PROSTATE PROS podcast. 

Liz:      [00:17] Clinical trials are the root basis for modern medicine and they're vital for the development of new treatments.  This episode, we're going to talk about pros and cons of clinical trials, who can benefit, which clinical trials to be most excited about.  We'll also address some concerns patients might have about participating. 

Dr. Scholz:      [00:37] Yeah, I mean, clinical trials are how doctors decide what to do for patients.  But today we're going to talk more about how patients can extract a benefit from participating in a clinical trial.  Some medicines are only available on clinical trials, they’re not FDA approved yet and trying to make a determination if you, specifically, would benefit by being in a clinical trial, getting an investigational drug is what this podcast today is about. 

Liz:      [01:05] So which type of patients in prostate cancer are looking for clinical trials? 

Dr. Scholz:      [01:11] It's really important as has been emphasized many times in the past, that there are different types of prostate cancer.  We call them stages or five different stages of prostate cancer and clinical trials are usually being performed in people with advanced metastatic prostate cancer, more often the type of cancer that is not responding to traditional medicines. 

Liz:      [01:34] So these are patients who have limited options left and clinical trials can allow them access to the newest treatments. 

Dr. Scholz:      [01:42] Exactly.  The problem with doing clinical trials is that there are always disadvantages.  If there are other FDA approved medications that have been already shown to prolong life why wouldn't patients use those first, especially since they are typically covered by most types of insurance? 

Liz:      [02:05] I think one concern people have is that clinical trials are either not covered by insurance or they're expensive.  Is this true? 

Dr. Scholz:      [02:12] Actually no, most of the time, clinical trials will provide the medications free of charge.  I think the disadvantages of clinical trials are that they’re somewhat cumbersome, there's a lot of paperwork, and it's very formalized.  So people are treated in a very uniform fashion, there's less room for creativity and adjustment of doses and things like that.  There's a major inconvenience to clinical trials.  Then of course the way that the medicine is used or whether or not there is a potential for getting placebos, these things can also be a disadvantage for patients who are participating in clinical trials. 

Liz:      [02:50] I think one other thing I was looking at clinicaltrials.gov to find the list of what's happening in prostate cancer.  A lot of the eligibility criteria is really strict, so I think that can be kind of a limiting factor as well. 

Dr. Scholz:      [03:05] Yeah, that's a very good point.  If people don't meet the criteria, then they can't enter into the trial.  I think it's challenging for patients to parse out, do they have the eligibility criteria that will qualify them?  It's not easy to read these trials and it's not like you can learn a trial and now you understand trials, every trial has its own unique design.  So the patients that are going to be able to utilize the vast industrial, investigational complex are those that can get online, read trials, and understand the eligibility criteria to determine if they would fit into that trial.  So it’s a shame to waste a lot of time, understanding the pros and cons of a trial only later to learn that you don't qualify.  Maybe you've had one too many rounds of chemotherapy or some other factor that kicks you out.  The typical problem is that these trials are not flexible.  Because you're a nice guy they're not going to give you a card to get into the trial.  You must fit the criteria. 

Liz:      [04:10] So clinical trials are another reason that you should be knowledgeable about your health and maybe have copies of your medical records.  You can reference those to see if you can fit into a trial.  How do patients decide if this is even something they want to pursue? 

Dr. Scholz:      [04:26] Well, as you mentioned previously, Elizabeth, the patients that have good options and there's thankfully a number of good options for men with advanced prostate cancer now probably should go with those first.  But it's always good to have a backup plan.  Many treatments will not work indefinitely and when things are going well, it's good to be looking into what you would do if the treatment you're using right now stops working.  Your doctor may have a clear plan and it may make perfect sense with drugs that are already FDA approved, if he hems and haws and says, “I don't know exactly what the next step would be,” perhaps now it's time to start looking into whether you would be eligible for some of the different clinical trials that are out there. 

Liz:      [05:12] So we're talking about men who have limited options.  On an earlier episode, we talked about off-label therapy and some of these clinical trial drugs can also be used in an off-label way.  How do we decide if patients should go the clinical trial route, or if they should get the drug off-label? 

Dr. Scholz:      [05:32] It may have to do the cost.  Sometimes the clinical trial will cover the cost of these expensive medications or maybe convenience.  It's more convenient to simply have your doctor prescribe a medication, which he can legally do using his own judgment.  If it's FDA approved somewhere for another cancer, perhaps.  This brings up the whole subject, which we've covered in the past of genetic testing as a way to determine if an off-label medication might fit for a patient, who's got limited options otherwise. 

Liz:      [06:08] So whether someone's using the drug in an off-label way, or they're on a clinical trial will you be checking their PSAs and just making sure their side effects are kept in check? 

Dr. Scholz:      [06:20] Precisely.  The issue is with any treatment for men with advanced prostate cancers is we really want results.  The type of people that are going into clinical trials have often tried a few different things and they've stopped working.  So we don't have time to dilly dally around.  We need results.  That usually means a decline in PSA once the treatment has started, or if people are having some bone pain that the bone pain goes away, some clear evidence for benefit.  This seems kind of obvious, but it surprises me sometimes that patients will patiently wait on a medicine, even though the PSA is steadily rising month after month, when really it's time to move on, if after two or three months there isn't evidence for a response.  

Liz:      [07:00] That's actually something I learned while researching this is that patients can stop clinical trials at any time, if they're not responding, or if they're having bad side effects, you're not locked in to the clinical trial. 

Dr. Scholz:      [07:13] Yeah.  Excellent point, because even though this is research, ultimately ethics demands that patients be treated in a fashion that's going to benefit them and not leave them worse off than they started before. 

Liz:      [07:27] So there are different phases of clinical trials and each has kind of a different set of requirements.  Can we start talking about phase I trials? 

Dr. Scholz:      [07:36] Yeah.  So phase I, II, III, and sometimes even phase IV.   Phase I is a brand new medication, so new, no one knows what the proper dosage is.  The only way to learn is by giving steadily increasing, incremental amounts to different patients to see, at what point did they start developing side effects?  So patients that are participating in phase I trials typically are, I would guess more desperate because there's no proof yet that it's going to work in humans.  There's probably been studies in animals, or other factors that indicate possible benefit, but phase I trials are dose finding trials.  If you are planning on going into a phase I trial, you really want to ask the investigator, have they tested it in other people yet?  Are there any signs that it's causing benefit and have they started to see any side effects?  For safety reasons they usually have to start at a very low dose, or if you're the first patient to go onto a phase I trial, there's a good chance that the dosage will be too small to benefit you. 

Liz:      [08:41] After a phase I trial is completed and successful.  Then next comes phase II. 

Dr. Scholz:      [08:48] Phase II trials are for patients who are going to be getting a drug that in a phase I trial was shown to be somewhat effective and also not excessively toxic.  So the advantages of a phase II trial are that people will be getting the proper dosage of the medicine.  It'll be with a medicine that we think has activity.  Another good thing is that everybody gets the medicine.  As we move on to talk about phase III trials, we get into the whole issue of placebos. 

Liz:      [09:18] Okay.  So phase III trials grow a little bit larger and you're either comparing the new drug to the standard treatment, or they're randomized with placebos, as you just said. 

Dr. Scholz:      [09:29] So phase III trials are usually pretty exciting because the phase II trials showed a benefit and phase III is necessary for the FDA to approve a drug for legal use in the United States.  Therefore the medicine that's being used is very likely to be helpful.  The problem of course, is the risk of getting randomized to a placebo.  That is obviously a concern.  Sometimes they randomize people two-to-one.  So your chances of getting the real drug are two-thirds.  The chances for getting the placebo is one-third also, if you embark upon one of these trials and there's a known set of side effects with the investigational drug, you can sometimes discern if you are getting the real drug or not, because the placebo patients aren't getting any side effects whatsoever.  If there's a response, clearly you're getting the real drug.  So patients do have the option of stopping the trial, if when they're taking the placebo, they feel they're receiving no benefit. 

Liz:      [10:31] A lot of the apprehension around clinical trials comes from this idea of getting the placebo.  And as Dr. Scholz just mentioned, this likelihood really only increases in the phase III trials.  How do you talk about this with your patients?  If you have someone coming to you saying “Dr. Scholz, I really want to participate in this phase III trial, but there's a chance I'm getting the placebo?”

Dr. Scholz:      [10:54] Like any other treatment decision we're looking at risk benefit ratios, we're looking at what other options do we have?  What is the chance at some other second or third line treatment option is going to benefit versus the investigational drug?  Sometimes these investigational drugs come into phase III with tremendous optimism.  There's a medication called Lutetium-177 that has just recently completed phase III trials.  But in the phase II trials, 30, 40, 50% of patients were responding to this with very few side effects.  So there was no doubt that this medication was beneficial. And of course one's best hope is that you get the medication rather than be randomized to the placebo. But other phase III trials were not so certain that the drugs are effective.  Those obviously are less attractive. 

Liz:      [11:45] All the medications that are used today, like Taxotere, abiraterone have all been through these phases of clinical trials, but there are a number of medications that never made it into the medical world because they failed at these clinical trials. 

Dr. Scholz:      [12:02] I would say that for every medication, FDA approved that we have in prostate cancer, there've been five, ten, or fifteen clinical trials that were just as optimistic and hopeful, but did not show a survival advantage when they were tested thoroughly in phase III trials.  We mentioned this because there's often a false sense that if it's in a clinical trial, it's new and improved and it's going to be better than what's on the market already.  I think that is becoming more common.  I think medical research is improving every year and the hit rate on these drug designs is getting to be quite good, but patients need to be careful that just because it's in a clinical trial, doesn't mean that it's going to turn into an effective drug. 

Liz:      [12:49] So our office does clinical trials.  How are you deciding which one of these seem like they will actually help your patients versus which ones you're just going to pass on? 

Dr. Scholz:      [13:01] I remember when a drug trial looking at high-dose vitamin D in combination with Taxotere was put on a phase III study and there was so much excitement because all the phase II trials look so good and everyone is already excited about vitamin D, but unfortunately it did not pan out.  The high doses of vitamin D with Taxotere gave somewhat lower response rates than the patients who got Taxotere alone. 

Liz:      [13:31] There are also phase IV trials, which are observational trials, looking to learn more about the drug after it's already on the market. 

Dr. Scholz:      [13:40] So the types of questions that pharmaceutical companies ask are in a larger number of patients, once it gets on the market, thousands of people will be undergoing therapy.  Are there other rare side effects, for example, that need to be tested for?  And the idea is that further experience with how the drug behaves in a larger population could be useful. 

Liz:      [14:05] If you'd like to see what clinical trials we're conducting at our office, visit prostateoncology.com.   Which current prostate cancer trials are you paying particular attention to?   

Dr. Scholz:      [14:18] Right now, most of the excitement is around immunotherapy.  People have heard about these medications, President Carter had an amazing miraculous response to a medicine called KEYTRUDA, which stimulates the immune system.  There are three phase III trials looking at KEYTRUDA in various combinations for men with prostate cancer.  There's also some work being done by Amgen, which tries to garner people's T-cells to attack cancer directly.  They use a bi-specific monoclonal antibody to attract the army cells of the immune system, the T-cells, closer to the tumor to kill off the cancer.  Some of the early phase II trials look pretty exciting.  The whole field of immunology is so hopeful.  We know that we're only at the beginning and if we can develop this technology and harness it, it's going to benefit a lot of people. 

Liz:      [15:15] There are so many clinical trials that it's often hard for doctors to keep up with them all.  So this responsibility falls on the patient's shoulders.  Clinicaltrials.gov is a great place that's organized, and you can find information there and then bring that information and have a conversation with your doctor. 

Dr. Scholz:      [15:35] If you understand your stage, you can look at the eligibility criteria and only be looking at the trials that would fit your profile.  Also, you know what limitations you have.  Can you travel to a different town?  Are you willing to go through the hoops that are necessary and the inconveniences to get into a clinical trial?  Once you select some potential candidates, your physician can help you decide if it's really a practical approach. 

Liz:      [16:04] One last thing to note is we've talked about how biased the industry is and unfortunately clinical trials are no different. 

Dr. Scholz:      [16:13] So the industry of clinical trials is heavily funded by the pharmaceutical companies.  I’m extremely grateful for these wonderful new medicines that these companies put in my tool chest to help patients with.  But there's a tremendous urgency to get patients involved in clinical trials.  They're very expensive to run.  You as a patient have to be careful that you're not being hurried into a trial that really doesn't benefit you.  There's always that potential that any warm body may fit. And if you are a savvy shopper, you can take advantage of these wonderful new drugs.  But, if you're not careful, it is possible for you to end up receiving medications that are very unlikely to help. 

Liz:       [16:56] As always, it's important to stay empowered and be proactive about your prostate health.  We'll keep you updated on the subject as more clinical trials emerge.  Thank you for listening.  Remember to email any questions or topics to [email protected].   

This episode of PROSTATE PROS reviews and summarizes the year’s advancements in prostate cancer as well as looks forward to future updates. Beyond prostate cancer, the episode examines how COVID-19 has impacted the healthcare landscape and discusses news of the vaccine. Catch up on the latest and stay tuned for an exciting announcement.

Liz:  [00:00] We have an exciting prostate cancer update.  Since recording this episode, the FDA recently approved the PSMA PET scan.  Keep that in mind when listening to the episode.  If you'd like further information, visit fda.gov.

Dr. Scholz:  [00:18] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I'm your host, Dr. Mark Scholz. 

Liz:  [00:24] And I'm your cohost, Liz Graves.

Dr. Scholz:  [00:28] Welcome to the PROSTATE PROS podcast.

Liz:  [00:31] A lot has happened this year and we've covered many topics on the podcast.  This episode we wanted to highlight a couple of exciting advancements and talk about some updates. 

Dr. Scholz:  [00:44] The elephant in the living room of course, is the COVID situation.  That's impacted the way we do business.  It's impacted our patients.  It's impacted all of you dramatically.  I thought I'd give a little update on what's happened in our over 2000 clients.  As you know, we serve a population of men between fifty and ninety plus our oldest patient just turned one hundred.  This is a high risk group.  Men are at higher risk for COVID complications and as we get older, particularly over 80, the complication rate goes up and the mortality rate goes up.  We've actually lost one patient to COVID in our whole practice in 2020.  It was an unfortunate individual that was traveling in Egypt in the January, February timeframe and when he came back to the United States he was ill.  This was before people were really clear of what was going on, went to the hospital with pneumonia, and unfortunately passed away.  We've had other patients, perhaps a dozen or so that have caught the COVID.  They're sort of evenly divided between men who really report that it wasn't much of anything at all and others, the other half, they got pretty darn sick, a really bad flu.  None of them fortunately had to go to the hospital. They all recovered.  This is rather remarkable considering our vulnerable demographic.  It shows that if people are careful and they isolate, they wash their hands, keep their hands off their face, most people aren't going to catch this.  Of course, when I talk to patients, I'm impressed by how much isolation is going on out there, how much care they are taking.  Many men have come to the office and said that I am the first out of the house experience that they've had in 2020.  So people are being very careful and clearly being careful does work. 

Liz:  [02:49] Yeah.  I remember early on in the pandemic, our office had way less traffic and was almost empty.  Now it seems like things are picking back up and people are checking back in on their health. 

Dr. Scholz:  [03:01] We've had a bunch of people come to the office who maybe had some cold symptoms, everyone's on edge, and we've tested them for the COVID antibody to see if they did indeed have previous exposure.  These tests are almost always coming back negative.  We're told by the scientists that these tests are probably 80% to 90% accurate.  They're not 100% accurate when you do the antibody test.  That's the test to determine if you've had previous exposure to COVID.  We believe, and some people disagree, that if you've had previous exposure and your antibody test is positive, that it's as if you've had a vaccination and you can't catch COVID and you can't transmit it.  That of course would be good news.  We've tested several hundred people now and almost all of them are negative. The ones that are positive are the ones that told us previously that they knew they had COVID.  These antibody tests confirm it.  This is a different test than the nasal swab, where doctors are trying to determine if you actively have the COVID virus.  Those tests are more accurate, perhaps approaching 99% accurate.  Patients who think that they have symptoms need to find a place to get tested, to rule in or rule out whether they are infectious.  After they've been sick, they want to be tested again, to make sure that the infection risk has gone away. 

Liz:  [4:38] We've had inquiries about where to get tested.  We usually just send whoever across the street to Cedar Sinai, and they'll do it there.  The turnaround on these test is quick enough that people can just wait for their results and they should know within an hour.  All right, Dr. Scholz, I think the biggest information about COVID right now is news of a vaccine.  I think one thing a lot of people are concerned about is how quickly this has developed vaccines usually take years, if not a decade to get developed. This has happened within a year, which is pretty incredible.  Do you think it will be safe? 

Dr. Scholz:  [05:15] So there's been debates, everyone's heard them, that will the vaccine work, will it have durability?  At this point, the preliminary science suggests that it will work and it will have durability.  There's three different companies that are putting forth a new product.  The hope is that by the end of the year we will be having people getting vaccinated.  Of course, there'll be selective preference for the elderly people in healthcare.  How this is all going to roll out is a big question.  But it seems at this point, there's no doubt that by early 2021 a vaccine is to be available and it will be effective. 

Liz:  [06:00] It is changing really quickly.  I know we were just talking about this last week and when I went back to review, I almost had to research it all again.  So it's important to stay up to date on this. 

Dr. Scholz:  [06:14] Yeah everything that we do in the oncology realm and in this realm as well is predicated on what we call a risk-benefit ratio.  We give dangerous medicine sometimes in oncology, but we are treating life-threatening cancers and sometimes rolling the dice and taking a chance with a treatment makes a lot of sense if the disease is much worse and very dangerous.  So it's going to be different for different people, for myself as a physician, meeting people all day long and basically in a high-risk situation, it seems to me that I'll be lining up early for the vaccination.  For those of you out there that are comfortable in your isolated state and are willing to sustain that, 2020 showed us that people can remain pretty safe if they're very careful, but the social isolation is taking a big cost in our patients’ mentalities, their lifestyles, their social lives.  It's been painful and difficult when people have to make a personal choice as to whether the relatively small risk of getting a vaccine is too great to consider as opposed to continuing in their existing lifestyle.  We’ll have more information every month as this vaccine rolls out as to how dangerous or how many risks there'll be associated with it.  That is unknown at this point.  But as a lot of people are going to be getting this vaccine, we should have very good information within a few months.  I think one last thing to emphasize is that we've learned that the COVID virus complication rate goes up astronomically in men over 80. Men over 80 and the elderly are at the very highest risk and mortality rates start to become very significant in this group.  It would seem to me that these elderly men are going to want to try and get a vaccine, even if there are some risks associated with the vaccine, because the virus for them is very dangerous. 

Liz:  [08:22] So another paradigm shift that occurred this year was the shift towards telehealth.  It seems like about half of our visits now are being conducted over the phone or via FaceTime or Skype. 

Dr. Scholz:  [08:36] This has been a really big change.  In trying to understand it and wrap my brain around it, it seems that it's a radical shift in accessibility.  In the past, phone visits were discouraged because the impetus was to get people into the office and be able to bill for your services.  Now, both private and Medicare insurance has essentially mandated insurance coverage for telehealth.  This has rapidly been accepted by patients due to the accessibility, the ease of communication.  It's even been nice to be able to take off my face mask and see the body language of my patients and communicate non-verbally with Skype and FaceTime.  In the office employees, patients alike are all wearing masks and we're making eyes at each other, using our voices and trying to overcome the muffled communication that has become routine now in our lives. 

Liz:  [09:44] I think something else that the telehealth has brought is connection.  Right now people are feeling kind of anxious and separated.  If they are skipping doctor's appointments to avoid waiting rooms and being close to other people, it’s such a great way to catch up on the latest in prostate cancer and catch up with you.  Your face appears in their living rooms and it's like they’re right in your office. 

Dr. Scholz:  [10:10] Yeah it is very personal.  It's as you all have experienced now, your face fills the screen and it's not as disconnected as people might think.  The risk to patients with telehealth is obviously reduced.  But one component of the way we do medicine, of course, is blood tests, injections, and treatments, and certain in office visits are still unavoidable.   If patients go to a remote facility for blood testing, they're still going to have some contact.  But so far as has been demonstrated, the COVID infection rate for our patients has been very low, whatever precautions people are taking seem to be working quite well.  One thing about telehealth is it appears to be here to stay.  I've talked to high-level insurance people about the future of telehealth asking, will it go away once the COVID risk disappears? The general consensus is that there's no going back.  This increased accessibility seems to be the future of medicine. 

Liz:  [11:19] So even big topics that are maybe a little more involved or confusing are easily addressed over Skype or FaceTime or a phone appointment.  Let's start talking about a couple of those that are new developments for 2020. 

Dr. Scholz:  [11:34] We already covered PARP inhibitors but they, being brand new treatments for advanced prostate cancer, merit a quick review.  PARP is an enzyme that helps repair DNA.  About 10% to 15% of men with advanced prostate cancer have a mutation that causes their DNA repaired to work less efficiently.  One application of this mutation, which is called BRCA, is that there's a little higher risk of getting prostate cancer.  The men who get prostate cancer that have BRCA tend to have a more aggressive form.  The PARP inhibitors exploit this mutation and men that have this mutation respond much, much better to PARP inhibitors.  PARP inhibitors are pills that make it even more difficult to replicate or duplicate DNA.  These already impaired cancer cells then die more easily and more quickly than your normal cells of your body.  We’re always looking for a differential effect with cancer treatments, a treatment that focuses more on the cancer, then your cells killing cancer without causing a lot of side effects.  So the medicines we're talking about are Olaparib and Rucaparib two new pills that help men with BRCA mutated cancer and are now FDA approved. 

Liz:  [13:01] These two approvals really highlight how important using genetic testing is.  This will help men with prostate cancer find treatments that may have only been FDA approved for another cancer.  Doing genetic testing is very easy.  It can be accomplished with a mouth swab or a blood test, and it's almost always covered by insurance.  So we briefly covered some updates and genetic testing. Let's review the PSMA PET scan really quick. 

Dr. Scholz:  [13:32] We did a whole podcast on this because it's a big breakthrough.  Most of you have heard of it by now, but for the first time we can accurately locate the prostate cancer wherever it is in the body and the prostate and the lymph nodes in the bones with one single scan.  This scan may be five times more accurate, ten times more accurate than any previous scan that was available.  What a wonderful addition to our diagnostic armamentarium.  This is going to have an impact for people with early stage disease, late stage disease.  Unfortunately, the FDA has not yet approved it, but we're anticipating approval within the next six months or so.  In that situation, it will be covered by insurance and it will be very popular. 

Liz:  [14:18] Some companies are investigating using PSMA as a therapeutic target rather than just a diagnostic target. 

Dr. Scholz:  [14:28] Exactly.  So the diagnostic scanning is incredibly useful reconnaissance for figuring out where the cancer is and helping design a treatment protocol.  But if we're able to accurately locate the cancer with these scans, wouldn't it be possible to use this same target, to make therapies stick to the surface of the cancer cells?  There are two very exciting types of treatment.  One we've talked about before uses an antibody to stick to PSMA and draw a high energy radioactive molecule right next to the cancer cell and kill the cancer cell.  This is called Lutetium- 177.  The phase three trials in prostate cancer have been completed.  We've had patients on trial or outside the country, get this treatment with very nice responses.  We're talking about a treatment for men that have already had chemotherapy, become hormone resistant to Zytiga and Xtandi, and who perhaps have limited treatment options getting nice PSA declines with relatively little, if any, toxicity.  There is a PSMA antibody on the salivary glands, so some people get a little bit of a dry mouth.  Some people with radiation, it can cause some lowering of blood counts, but for the most part, there's practically no side effects with dramatic responses to Lutetium-177.  The phase three trials are completed and they're waiting for them to mature to validate that there is a survival advantage.  Once that happens and the study results are released, the FDA has six months to approve or disapprove the treatment for broad spectrum dispersal amongst the population for therapy and insurance coverage. 

Liz:  [16:14] So it seems like there's a lot to look forward to with PSMA being used as a diagnostic test as well as its role in therapeutics, especially for men with advanced prostate cancer.  There are a couple immunotherapies that are exciting on the horizon.  Can we talk a little bit about those?

Dr. Scholz:  [16:36] Amgen has developed a connector molecule that instead of linking a radioactive moiety to the antibody that clips to PSMA, it's sort of like a pheromone tag that draws in your T-cells.  I don't know how many of you are familiar with how the immune system works, but the soldier cells of the immune system are called the T-cells and the T-cells are the component of your immune system to go in and attack the cancer cells and kill them directly.  Theoretically, if you can get the T-cells in close approximation with the cancer cells, they will attack and kill them.  There is new technology from Amgen, a very large pharmaceutical company, that has developed this and is doing phase two testing in men with advanced prostate cancer and responses are indeed occurring.  So the patients are injected with a substance that clips onto PSMA i.e. the surface of the cancer cells and draws the patient's immune system close to the cancer cells so that it will attack it.

Liz:  [17:49] As you can see, there's so much information about prostate cancer this year alone, we've covered focal therapy, brachytherapy, radiation, immunotherapy, chemotherapy; the list goes on and on.  So looking forward, it's important to always stay in touch and stay up to date and keep sharing and keep listening.  You might find it useful to go back and review old episodes of PROSTATE PROS. You can find us on your favorite player.  So Dr. Scholz, another exciting thing 2020 was the 10th anniversary of your first book Invasion of the Prostate Snatchers.  Something you may not know is that this year, Dr. Scholz and I have been working hard to update his first book Invasion of the Prostate Snatchers.  So about 10 years ago, when the first edition was published, it was really the first introduction to active surveillance.  I think Dr. Scholz received a little flak from that, and now it's more widely accepted, but with that, there's still a lot of the industry that patients need to be careful of.  That includes over-treatment.  That includes dangers of surgery and random biopsies.  So we're really looking to restart the conversation, and get patients to be their own advocates. 

Dr. Scholz:  [19:16] There's a theme in the prostate cancer world that you have to educate yourself.  I hope that both of my books encourage people to do their own research, to take responsibility for their health and to double check the information, rather than just accepting the first pitch you hear from a doctor.  Prostate cancer is big business.  It's a multi-billion dollar world, and people are trying to make a profit.  Ethically, no doubt, there's so many gray areas in the prostate cancer world.  You need to double-check and you need to find the original, basic information that leads you to the truth. 

Liz:  [19:59] So this new completely rewritten second edition of Invasion of the Prostate Snatchers will be out in 2021.  We're really excited to share it with you.  Telehealth has really connected us this year, and we're looking forward to staying connected in 2021.  Remember to tune into the podcast and share with your friends.  If you have any topics you want us to cover in the upcoming year, you can email us at [email protected].

Correctly assessing prostate cancer’s spread is essential for staging and treatment options. Until now, scanning technology has lacked both clarity and specificity, leaving treatment recommendations to partial information and guesswork. The new PSMA PET scan changes this. This episode of PROSTATE PROS explores the benefits of the PSMA PET scan and how it can be used to make intelligent treatment decisions. READ MORE ABOUT ON OUR PROS BLOG.

Dr. Scholz:      [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I’m your host, Dr. Mark Scholz.

Liz:      [00:09] And I'm your cohost, Liz Graves. 

Dr. Scholz:     [00:13] Welcome to the PROSTATE PROS podcast. 

Liz:      [00:17] Prostate cancer imaging has improved tremendously over the last decade. Advanced imaging means safer screening, more accurate staging, monitoring, and targeting. 

Dr. Scholz:      [00:29] Liz, I'm glad we're going to address this new area of prostate cancer imaging because there's one scan in particular called PSMA PET scan, which is revolutionizing the field. 

Liz:      [00:42] So PSMA stands for prostate specific membrane antigen.  This is a scan that I hear you talk about all of the time in the office.  Can you tell us what it does? 

Dr. Scholz:      [00:55] Whenever we're talking about scans we're always trying to answer the $64,000 question: Where is the cancer?  The scary thing about cancer is it can spread and with prostate cancer, of course, ideally we want the cancer to stay confined inside the prostate gland.  Historically, we've had a variety of scans to look throughout the body, MRI scans, bone scans.  The problem has been that these scans are nonspecific, they can light up with injuries and other cancers and all kinds of confusing things. And they're not really that accurate so they can miss cancers outside the prostate, even when they're there. 

Liz:      [01:37] PSMA only shows where the prostate cancer is located in the body. 

Dr. Scholz:      [01:43] That's right.  And let's reiterate, of course, that prostate cancer that spreads to a lymph node or to the bones doesn't become bone or lymph node cancer, it's still prostate cancer. And the PSMA signature stays intact, even if it gets into another part of the body.  So if a spot lights up on the scan, this new PSMA PET scan that we're talking about, it means there's some prostate cancer there. 

Liz:      [02:09] I'd imagine this is really important for staging.  Right now you are using a lot of different ways to predict if the cancer has spread, but with this PSMA scan, you'll know for sure. 

Dr. Scholz:      [02:22] That's very well stated.  The historical use of Gleason Score was to try and predict the likelihood of something being outside the prostate or how high the PSA is.  High PSAs were statistically more likely.  This scan is so much more accurate than anything we've had.  Now, if the scan is negative, it doesn't entirely prove there's no cancer outside the prostate, but it gives us a lot more confidence that the cancer is still confined inside the gland.

Liz:      [02:50] The scan seems pretty revolutionary, is everybody getting this?

Dr. Scholz:      [02:55] PSMA PET scans are available in a number of research centers, university centers around the country right now.  And they are usually associated with some sort of a financial charge, but the information is so valuable, the money is usually dollars well spent. 

Liz:      [03:13] Besides having enough money to afford the scan who's eligible, is it every stage?

Dr. Scholz:      [03:19] It is almost every stage.  The exception would be men with what we call SKY or Low-Risk prostate cancers, MRIs are more accurate for delineating the exact size of spots inside the prostate, but for pretty much every other stage this is the best scan experience has shown that men with PSS that are below 0.2 are not going to light up on the scan.  That’s a pretty remarkable threshold because with older scans, people needed PSAs of one to two, with something like Axumin perhaps, or 10 to 20, if it was a regular bone scan. 

Liz:      [04:00] So you mentioned Low-Risk, and these are cancers that as far as we know, haven't spread, is there a situation where these men would want to get a PSMA scan? 

Dr. Scholz:      [04:11] You know, I have used it.  That's not normally the way we would use the scan, but there's a situation where men are thought to have SKY, Grade 6, prostate cancer, but many times we run into men that have high PSA levels, perhaps from prostatitis or big prostates.  There's this nervous niggling concern that could the cancer have spread somewhere outside the prostate.  So it brings a lot of comfort when you have a high powered scan like this into play and show that no, indeed it is only still in the prostate.  So while we don't routinely use this type of scanning, the PSMA PET scan for men with localized disease, certain men that are running high PSA density, that means the PSA is higher than we would expect in regard to how big the prostate is.  We might consider doing a PSMA PET scan, and we have done that in a few cases. 

Liz:      [05:06] So let's say one of these men does want a PSMA PET scan before that because they have local disease.  They would probably have had a 3T mp MRI or a color Doppler ultrasound. 

Dr. Scholz:      [05:20] Yes, exactly.  So we have literally hundreds of men we're monitoring on active surveillance.  Our typical policy is to do imaging with 3T multiparametric MRI and/or color Doppler ultrasound.  These provide the greatest resolution for imaging inside the prostate gland.  So if a person's previously had a biopsy and we know where the cancer is and what the grade is, and they're under surveillance, sequential scanning can determine if those spots are growing. And so that is how we determine if someone will need further biopsies.  Secondarily, we do look at PSA, but PSA is just not very accurate for this sort of purpose. 

Liz:      [06:03] We talked about Low-Risk, but how does this new scan help men with High-Risk prostate cancer? 

Dr. Scholz:      [06:10] So what High-Risk means, and it's good to define terms, it doesn't mean a High-Risk of dying, it means a higher risk of microscopic spread outside the gland so that men who would undergo surgery or radiation would be at a higher risk of not being cured.  So to compensate for that doctors give men TIP or testosterone inactivating pharmaceuticals, androgen deprivation, to try and mop up those little specks that might be out there just because someone has a higher Gleason Score or a higher PSA, but this scan is so much more accurate.  It raises the question: If the scan doesn't show any spread can men with High-Risk disease skip taking the testosterone blockade and simply monitor with sequential scans annually after the treatment?  And if some little tiny speck shows up in the future then treat it with radiation and perhaps some hormone therapy at that point.  This would be a wonderful advantage for men because as we all know, four to 18 months of testosterone blockade is a very onerous treatment with a lot of side effects.  So these scans may enable men to either reduce or eliminate the testosterone blockade. 

Liz:      [07:24] You just mentioned sequential scanning.  How often would you do that for someone with the PSMA scan? 

Dr. Scholz:      [07:30] So if someone has High-Risk disease and they're in complete remission, it would probably depend on how High-Risk, but it's funny how often in the scanning world, like for instance, with SKY, we do MRIs once a year, color Doppler once a year, and annual follow up is sort of a common rhythm.  Unfortunately, we don't have any studies yet to tell us what is going to be the optimal scanning period. 

Liz:      [07:56] I know that a lot of scans have a lot of radiation or you have to use contrast.  And these are a couple of things that can make it a little messy when considering getting a lot of scans in a row, is that something people need to be worried about?

Dr. Scholz:      [08:10] It could be.  The contrast or the radiation exposure does incur a small risk.  Of course, in men with sky cancers, doing a lot of scanning that has radioactivity would be inappropriate, but as people get higher risk cancers, of course the disease itself becomes more risky than the side effects of the radiation. 

Liz:      [08:31] We've been talking about a lot of applications for this, but the most common application is finding relapsed disease. 

Dr. Scholz:      [08:40] Exactly.  So people that have had surgery or radiation, their PSA should go down to very low levels and remain there indefinitely.  But PSA relapse is really common about 25% to 35% of men will have a rising after surgery or radiation someday.  Then the big question is, well, where's it coming from?  In the past, we really just had to deal with guesswork.  There is another type of scan called Axumin, which is FDA approved, which was definitely progress because when the PSA got to be around one, two, or three oftentimes it was possible to find the location of the cancer.  What’s marvelous about the PSMA PET scan is you can start scanning when the PSA is as low as 0.2. 

Liz:      [09:27] So I would imagine if something's found that relapsed disease is happening and there are mets that you can start treatment right away. 

Dr. Scholz:      [09:36] Yes.  And it's directed treatment.  Usually the problem is located in the pelvic lymph nodes.  That's the first jumping off spot.  The doctors, now with modern radiation, can safely zap those spots and people get a second chance for cure. 

Liz:      [09:53] Moving on to men with advanced prostate cancer.  These are men that have mets outside the lymph nodes and maybe even in the bones.  So in the past, these men had to get all sorts of scans.  They had to get bone scans, CT scans, but now with the PSMA PET scan, they might only have to get this one scan. 

Dr. Scholz:     [10:16] I think that's a great advantage with these scans, but in addition, of course, this is even more accurate.  So if the CAT scan showed one or two enlarged lymph nodes and the bone scan showed one or two spots, the PSMA PET scan is so much more powerful and accurate, it may reveal significant numbers of new spots that weren't seen on the old scans. 

Liz:     [10:42] How is that helpful?                                    

Dr. Scholz:      [10:45] Well, treatment is tailored to how many spots are present because if only two or three spots are present, you can zap them with beams of radiation and try and sterilize them.  But if there's a myriad of spots out there, medicines that circulate through the bloodstream, hormone therapy, chemotherapy, immunotherapy, is the best way to go. 

Liz:      [11:07] So the PSMA PET scan can be used for people with all different stages, and it can really help guide treatment and stage patients.  Dr. Scholz, it seems like almost every person with prostate cancer should get this scan, but it's only approved in other countries, why is that?

Dr. Scholz:      [11:26] There's been a lag in the United States with the completion of the clinical trials. And I'm not sure exactly why.  This technology was actually invented 20 years ago.  A guy named Neil Bander came up with a PSMA antigen and thank God now fruition is near.  The studies have been completed and we're waiting for them to break the code and render proof that these scans are actually as good as we're talking about.  And we know that they will be.  Once the code is broken and the studies are published, there's usually a three to six month delay until the FDA approves the scans for commercial use. 

Liz:      [12:04] So for now finding PSMA PET scans is usually at a university or through a clinical trial. 

Dr. Scholz:      [12:12] Yes.  And unfortunately it's associated with a charge sometimes $1,000 to $3,000 per scan.  They're pretty pricey, but I've found that the information has been so useful that many patients are willing to invest the dollars necessary to get the information. 

Liz:      [12:30] Let's say someone doesn't have the resources or the money to get a PSMA PET scan. What are these people supposed to do?  

Dr. Scholz:      [12:37] Well, we've been getting by without PSMA PET scans for 20 or 30 years and the PET bone scans, the Axumin PET scans, and good high quality MRIs have enabled us to improve prostate care to a tremendous degree.  The PSMA PET scan is definitely an advance.  In fact, I've been billing it as the biggest discovery since PSA, but it is the way we've been practicing without PSMA PET scans is certainly viable.  And with expert care, doctors can use these slightly inferior technologies to make reasonable decisions and gage what the best approach will be. 

Liz:      [13:20] So this is a really exciting topic, and we are a little early talking about it as it isn't FDA approved yet, but it will be soon.  We're posting more information about it on our blog, prostateoncology.com/blog.  We're really excited to keep you up on the latest in prostate cancer.  You can email any questions or topics to [email protected].  Remember to help us out by rating, reviewing, and subscribing on Apple Podcasts.

Testosterone naturally decreases with age. This can mean loss of libido, fatigue, and decrease in muscle. So why are you waiting for your doctor to talk to you about your low testosterone? What solutions are you missing out on?

Testosterone replacement therapy can help reverse side effects of low testosterone and improve quality of life. This episode of PROSTATE PROS covers how testosterone replacement therapy can be used for aging men, men with chronically suppressed testosterone after TIP, men with advanced prostate cancer, and even spouses.

Dr. Scholz:  [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I’m your host, Dr. Mark Scholz. 

Liz:  [00:09] And I'm your cohost, Liz Graves. 

Dr. Scholz:  [00:13] Welcome to the PROSTATE PROS podcast. 

Liz:  [00:20] Testosterone is the primary male hormone.  As men age testosterone naturally decreases.  Low testosterone can mean loss of libido, fatigue, or muscle loss.  This episode we're going to talk about testosterone replacement for aging men and men with prostate cancer. 

Dr. Scholz:  [00:39] So this is a controversial thought.  Men with prostate cancer often are treated with testosterone blockade.  There are situations though to consider giving testosterone.  We're going to briefly cover three broad categories: aging men, as Liz mentioned, category number two will be men that have had previous TIP or testosterone inactivating pharmaceuticals and their testosterone just isn't recovering normally, and then the third situation is in very advanced prostate cancer.  There are controversial new treatments to administer high-dose testosterone as a form of therapy to control prostate cancer. 

Liz:  [01:22] There are a lot of appeals of testosterone replacement.  One being that it can help return your libido, two, it provides energy, three, it assists in muscle gain, and four, it can improve your mood. 

Dr. Scholz:  [01:35] One of the things to realize about testosterone is that the blood tests give you an accurate number, but they don't necessarily tell you how you're going to feel.   Throughout the years I've seen how some men have rather low testosterone, but feel perfectly fine.  Other men may have somewhat or mildly diminished testosterone, but really feel poorly.  So, one of the things to know in this whole realm of giving testosterone is that the lab numbers, the amount of testosterone in the blood, is not the most important thing—it's how men feel—because giving testosterone is designed to restore a better quality of life, provide energy, improve libido.  If men are already feeling well, you really can't improve on that. 

Liz:  [02:22] Is testosterone something that's tested annually or do men have to ask what their testosterone levels are?

Dr. Scholz:  [02:29] Oftentimes this is something that gets overlooked.  Of course, physicians tend to think that as men get older, their testosterone levels are going to drop and that even if they are somewhat low, that's just part of life.  So I think it's a good question to put to your physician is “is my testosterone normal?”  This is particularly relevant for men that are over age 60.  If testosterone levels are running low, there are situations where men are going to feel better if they take some supplemental testosterone. 

Liz:  [03:00] So Dr. Scholz, if you have an older man who has no known prostate cancer, and he goes to the doctor and asks about testosterone replacement, will the doctor say, “there's no way, that's going to cause prostate cancer?” 

Dr. Scholz:  [03:15] You may get that kind of an answer.  This thinking is rooted in the fact that many people are aware of the fact that when you block testosterone, prostate cancer shrinks.  So they falsely assume that if you give testosterone, you'll make it grow.  But this concept has been tested very thoroughly.  Testosterone does not cause prostate cancer.  You certainly can treat prostate cancer by removing it.  That may sound controversial, but this has been studied very thoroughly. 

Liz:  [03:50] So older men can safely get testosterone replacement. 

Dr. Scholz:  [03:54] So yes, older men can get testosterone, but there are other concerns.  Some men will make excessive red cells.  That's the opposite of anemia.  If the red count goes too high, it could place these men at risk for heart attacks or strokes.  So it's certainly something that has to be monitored appropriately and carefully. 

Liz:  [04:18] How do you test for red blood cell counts that are too high? 

Dr. Scholz:  [04:22] Really anyone that's taking testosterone, I recommend that they look at their own test results, things get lost in doctor's offices and this is so important that if people are going to do testosterone, we want it to be safe.  So the test is called a CBC or a complete blood count.  It's a very inexpensive and commonly used test.  The section of the testing that you look at is called the hematocrit.  The hematocrit should be less than 50%.  If it starts going above 50%, that's too many red cells and men should consider either reducing the dose of testosterone or possibly going down to the Red Cross and donating a little blood—that will bring the red count down as well. 

Liz:  [05:04] So we're talking about giving testosterone.  What does that mean?  Is it a shot?  Is it a pill? 

Dr. Scholz:  [05:10] It turns out that there are a lot of different ways to give testosterone.  I think the big resurgence has been because you can purchase a cream with a prescription that you can rub on your skin every morning.  It'll go through the skin and restore testosterone levels.  There’s other ways:  There are long acting shots, there are short acting shots and there are patches, I think they have lozenges that you can actually put on your tongue.  All of these things have their pros and cons.  I'd say the two most common approaches that we use are either the injections, which are given under the skin like an insulin shot, every week or two, or the creams, where someone is just rubbing a gel on their upper arms and chest every morning. 

Liz:  [06:00] Giving testosterone really depends on the patient.  Are dosages matched to that? 

Dr. Scholz:  [06:05] What we typically do is we start someone off on a standard dose.  Say, if you're getting an injection every two weeks, we'd give 200 milligrams of testosterone under the skin every two weeks, and this can be done by the patient himself.  We let that run for a couple months, bring the patient back, check the CBC, make sure the red count isn't going up, recheck the testosterone levels. Then, most importantly, ask how the patient is feeling.  Is he actually getting a benefit?  Then the dosage can be adjusted up or down.  You can say, well, what does excess testosterone feel like? And some men, you know, they're a little jittery and they don't have a sense of calm and it could be a sign of too much testosterone. 

Liz:  [06:55] Dr. Scholz, does everybody with low testosterone feel better after they start testosterone replacement? 

Dr. Scholz:  [07:02] Interestingly, the answer to that's no.  So you can see people who are running low testosterone and then you give it to them and you can bring them back. Their blood levels are now normal because they're taking enough testosterone to make the blood levels normal, but they don't feel any different.  This is one of the confusing things.  Some men we've put on hormone treatments to block testosterone and they don't feel any different.  That's not common, but it turns out we all have a little bit different wiring.  And this is why it's so important to have good communication between the physician and the patient about what you're accomplishing.  Just creating a normal number on a blood test isn't really accomplishing much.  The whole point is to restore quality of life.  I've had men we give three or four months of testosterone replacement and they say, honestly, Dr. Scholz, I just don't feel any different, I don't see the point.  We'll stop it at that point.  So it's a quality of life decision just as much or more than it is a laboratory finding. 

Liz:  [08:06] A lot of men are really afraid about losing their testosterone when they go on hormone therapy.  Let's talk a little bit about testosterone replacement for men with prostate cancer. 

Dr. Scholz:  [08:17] One of the most popular ways to administer TIP is with an injection called Lupron and treatment is administered for variable periods from four to 18 to 24 months.  After that, we know that there's no additional value for continuing the treatment any longer, but especially as men get older above age 70, the recovery of natural testosterone production is greatly delayed or sometimes permanently suppressed.  The question arises if other men are allowed to get their normal testosterone back and it's known to be safe, why can't we administer testosterone in the men whose testicles have just given up the ghost and stopped working?  The answer is you can give testosterone to these people and it doesn't increase the risk.  It allows men that have been on a course of hormone treatment who failed to recover normally to get back their good feelings associated with having a normal testosterone level. 

Liz:  [09:22] How long do you wait to make the judgment if someone's testosterone is going to come back or if it isn't? 

Dr. Scholz:  [09:29] Typically we'll allow men about six months after the TIP has been stopped to start to generate their own testosterone.  Then if the testosterone levels are still greatly lagging, or perhaps haven't even started to rise, we'll start a discussion about this with the patient about the possibility of taking testosterone so that they don't have to live in this deprived state for, you know, several years, perhaps.    

Liz:  [09:57] Do you find that a lot of your patients are nervous about starting testosterone? I mean, they just went through this whole process to get all their testosterone out of their system and now you're putting it back in. 

Dr. Scholz:  [10:09] They are, initially.  After we explained that the whole point of stopping the Lupron is to recover testosterone, it seems to make sense to people. But oftentimes people haven't thought it through.  And many people feel like they've dodged a bullet, they're grateful that their PSA is undetectable.  I do have some patients that decide that they feel better with a zero testosterone and a zero PSA.  Of course we have to take precautions for those people because they're at increased risk for osteoporosis and other side effects, but people can manage a chronically low testosterone.  If they're comfortable with that, it, as I said before, is a quality of life decision. 

Liz:  [10:52] So it is generally safe to give testosterone to men with prostate cancer.  My question is: does it matter if someone's hormone resistant or hormone sensitive? 

Dr. Scholz:  [11:04] Yeah, of course we're talking about giving testosterone in very structured situations.  There are definitely situations where men shouldn't be taking testosterone.  If they're on Lupron to keep their testosterone low, we want to maintain that low testosterone until we've gotten the maximum anticancer value out of it.  But, for men that have hormone sensitive disease or possibly have been cured, they took radiation and we think they're probably cured and there's no guarantee yet, but it is safe to give them some testosterone, under careful supervision.  But the other question you asked is what about men that have advanced prostate cancer?  We know that they're not cured but they've been on Lupron and their PSA has become undetectable.  In the old days the thinking was, wow, aren't we fortunate to get people into a complete remission, let's not mess with success.  But, clinical trials have been done showing that it is possible to be exposed to testosterone, intermittently and variably in these men with more advanced disease, the PSA will start rising.  The studies show that it's safe to let the PSA rise up to maybe 5 or 10 and then Lupron should be restarted.  So there are situations even with known, persistent cancer where men can take testosterone and their quality of life is improved by doing that. 

Liz:  [12:37] Are these men getting their PSAs tested monthly, weekly? 

Dr. Scholz:  [12:41] Well it's in someone that’s achieved a complete remission, we call that a PSA less than 0.1, things move pretty slowly.  So we'll probably check their blood tests every three months or so. 

Liz:  [12:52] Testosterone can also be used to treat prostate cancer.  Can we talk a little bit about that?

Dr. Scholz:  [12:59] So this is new and controversial, but the research that's been done comes out of some reputable university settings, that makes their findings believable.  These relatively small trials, you know, in 30 or 40 patients, what's been done is for men with very advanced prostate cancer who have become resistant to practically every known treatment.  There have been men, who've had PSA responses and cancer regression through the administration of an injection of testosterone which is very counterintuitive because these men, no doubt have had their testosterone very low for years in their battle against advancing cancer.  So this cyclical injection of testosterone given on a monthly basis is causing PSA declines in some men with very advanced disease.  The idea of giving testosterone as a therapeutic maneuver to earlier stage prostate cancer hasn't been tested and may not be a very practical idea, but as a last ditch effort in certain individuals, it may be helpful. 

Liz:  [14:11] Are there any other unrelated concerns about testosterone? 

Dr. Scholz:  [14:15] Not really.  It’s more doctor visits, some careful monitoring, occasional blood tests, but one interesting thing is that men with diabetes or borderline blood sugar problems get better control of their blood sugar levels when they take testosterone.  So for the most part, we think of it as kind of a tradeoff of convenience, quality of life without a whole lot of medical ramifications, but for men with diabetes, it may be better if they take testosterone and try and restore their normal levels. 

Liz:  [14:49] As I was researching for this, I came across giving testosterone to women.  This is called bioidentical hormones.   Why would we do that, Dr. Scholz?

Dr. Scholz:  [15:00] Many people are unaware of the fact that women have testosterone too.  They obviously have estrogen, but the testosterone, the small amounts of testosterone that are secreted by the ovaries create libido in women.  A lot of the spouses of the patients in my age group are postmenopausal and they've lost their estrogen and they've lost their testosterone.  As a result have a low libido.  Some of the other advantages of testosterone, two of course, are better energy, more strength and more stable mood, a sense of wellbeing.  So it's become popular to give small doses of testosterone, to postmenopausal women, to restore the normal range, so they feel better and that they have a return of their natural libido.  This comes up in my practice a lot because when men are on TIP with chronically low testosterone levels, and now are starting to recover after stopping TIP and getting their libido back, it will come up in conversation.  They'll point out that their spouse doesn't really have much interest in the resumption of sexual activity.  So I typically at that point will refer them to a physician who specializes in giving bioidentical hormones.  And there's an educational process because it sounds, you know, taking chemicals and all this sort of thing.  But the treatment is usually administered with a cream that's rubbed on every day.  A lot of women enjoy it also because it can help with weight loss.  So the idea of restoring libido in one spouse without doing it in the other seems a little bit problematic and sometimes both members need some supplementation. 

Liz:  [16:51] So there's a lot to talk about when it comes to testosterone replacement.  And this comes up in our office a lot because we are so conscious of quality of life.  Is this something that your patients bring up with you, Dr. Scholz?  Or do you talk to your patients about it first? 

Dr. Scholz:  [17:09] Well, a lot of our patients, we attract a clientele that's pretty much into doing online research and so patients will bring it up, but half the time, I think you're right, if we didn't broach the subject, I think it would just sort of lay there unmentioned.  People tend to be a little nervous talking about sexuality and these sorts of things, and they may figure that just, well, I had prostate cancer and I'm stuck with whatever situation I'm in.  So I'm glad you raised that point that we sometimes, well in certain practices that may be necessary for patients to broach the subject.  So in summary, the administration of testosterone to prostate cancer patients is feasible, practical, and helpful.  It does need to be carefully supervised.  The beauty of prostate cancer is that PSA gives you very quick and accurate feedback as to what is actually going on.  There's a lot of education involved because it's not just following the numbers.  There has to be a dialogue between the physician and the patient about quality of life, energy levels, libido levels, and what the goal is.  Some of my men are such diligent exercisers, even with a low testosterone, they feel pretty good.  Some of my patients really enjoy having a low PSA and they don't want to rock the boat.  That's a perfectly fine attitude if all the other compensatory things are done to keep muscles strong, keep bones strong, and to keep your energy up through exercise. 

Liz:  [18:49] I know a lot of men have questions about this, so thank you for approaching this topic today.  If you have any questions about testosterone replacement, email them to [email protected] and we'll bring them up in another episode.  This is another important topic to share, and you can share it with your friends that don't have prostate cancer, and even your wives.

Many men are interested in (or are already taking) supplements and vitamins for their prostate cancer. How effective are these alternatives compared to traditional medicine and treatments? Sifting through the massive amounts of information on supplements and natural medicine is no easy task. PROSTATE PROS examines current trends and explores which supplements may help men with prostate cancer and which they should avoid.

Dr. Scholz: [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls. I’m your host, Dr. Mark Scholz.

Liz: [00:09] And I'm your cohost, Liz Graves.

Dr. Scholz: [00:13] Welcome to the PROSTATE PROS podcast.

Liz: [00:20] Alternative, natural therapies appeal to many people, but when it comes to prostate cancer, how much of this is just hype and how much is rooted in science? On this episode, we'll dive into supplements, minerals, and other natural options as they apply to prostate cancer.

Dr. Scholz: [00:37] Liz, at the beginning, I think we ought to give credit to a good friend of mine and professional colleague, Mark Moyad, who wrote a wonderful book called The Supplement Handbook. I am using some of the clinical trials cited in that book as we go through our discussion today. It is an excellent book, you can get it at Amazon, of course. It covers more than a hundred different conditions and prostate cancer is a small portion of it, but people are always interested in supplements and how they affect a wide variety of issues.

Liz: [01:09] We see this a lot with our patients. I would say you get at least an email a week from a patient asking if they should try the latest, this or that. We recently had a patient email about using mushrooms to treat prostate cancer. What do you reply when you get these emails?

Dr. Scholz: [01:26] Well, one thing I'm excited about is that they're testing the concept. So much of what's out there is based on someone saying “I felt better,” or some company has a strong marketing program. Supplements, if they're effective, should show an effect in randomized, placebo controlled trials. There's a big placebo effect. We're all susceptible to positive thinking, which is a wonderful thing, but you can give people a sugar pill and 25% to 30% of people improve. So when you do a test, you have to check the new substance against the placebo and you have to show a better outcome than the placebo accomplishes. Otherwise you're just giving another placebo.

Liz: [02:11] So in judging the efficacy of these supplements and minerals, you suggest trying to find studies?

Dr. Scholz: [02:18] Either to try to find studies, if you want to participate, but more importantly, know the studies or find supplements that are backed up by clinical trials that have been shown to be efficacious.

Liz: [02:30] Now, let's talk about some popular trends for your patients. One of those is a vitamin C infusion.

Dr. Scholz: [02:37] Vitamin C infusions have been around for a long time. Linus Pauling popularized this 30 years ago, 40 years ago. Vitamin C has been shown to shorten the duration of colds, it's been shown to improve healing after surgery, and it has been tested as a treatment for cancer. I've had a number of patients that have come to me wanting to do vitamin C infusions. And because I haven't seen convincing evidence that it works, I've been unwilling to do it in my own office. But they have gone to other offices and we check their PSA monthly. I asked them to stop their other treatments so we can tell what's working without any confusion. So far in over a half a dozen men, I have not seen a single case where the PSA has stabilized or dropped. It's been disappointing. Vitamin C is well tolerated, so they're not having any side effects, we're just not seeing results.

Liz: [03:36] So how long are people getting vitamin C infusions? Is it three weeks or five weeks?

Dr. Scholz: [03:41] Because prostate cancer tends to react slowly, if you look at PSA responses to other well-known treatments, hormone therapy, chemotherapy, it can take two or three months before the PSA will start to decline. So what we'll often do is ask them to come in monthly for a PSA. If after two, three or four months, the PSA is not budging, in other words, if it's continuing to rise, then patients actually quickly become convinced that this really isn't working.

Liz: [04:14] So getting your PSA tested regularly is important when trying to decide if a vitamin or supplement is working for your prostate cancer.

Dr. Scholz: [04:22] Yes, this is one of the unique things about prostate cancer: We have PSA. PSA is derided because it's sort of nonspecific for screening the general population, but it is a tool to monitor known prostate cancer, in particular, men that have had previous surgery. 75,000 to 80,000 men a year have radical prostatectomies for prostate cancer and about 25 to 30% percent of those men relapse. Their relapse is signaled by a rising PSA. We measure the doubling time: How quickly is it rising? That gives us an indication of how serious it is. So it's a great place to do clinical research to find out what is effective in controlling the cancer progression.

Liz: [05:09] Other natural products that are associated with prostate cancer are soy, selenium, vitamin E, broccoli, blueberry, green tea, and pomegranate. I know there was a lot of controversy around pomegranate. Can we talk about if that works for prostate cancer?

Dr. Scholz: [05:26] I think pomegranate is a great illustration because all the early trials, which were not placebo controlled, showed a benefit. 25%, 30%, 40% of men whose PSA levels were rising after surgery seemed to stabilize for at least a period of time. Later someone did a randomized placebo control trial, and that trial showed that pomegranate worked just as well as the placebo did. So this is why, without good quality trials, it's easy to come across small human trials showing that something slows or stabilizes PSA, but if it's not compared with a placebo, you get the false impression that it's efficacious. Sometimes things even turn out to be worse. Not that many things are studied in controlled clinical trials because it's expensive to do. But, both selenium and vitamin E have been studied in multimillion dollar studies because of early indications that they had anticancer efficacy. It turned out that the patients on those products either had unexpected side effects or did worse with the vitamin E and selenium as compared to a placebo.

Liz: [06:38] I think something everyone is susceptible to, you and I have talked about this is, is getting excited about these. You think vitamin E is going to work and it's like, great. I don't have to do chemo. I just gotta take this vitamin. Like, that's so wonderful! But the thing is, is there's no magic bullets.

Dr. Scholz: [06:57] Yeah. I think there's a whole industry that feeds off the woeful state of cancer patients and big marketing budgets and selling supplements. So it's not that some supplements don't have a role, it's that the industry behind it is profit driven and patients who have cancer are very vulnerable.

Liz: [07:18] Is it true Dr. Scholz, that if you take a lot of these supplements, it can actually increase your risk of prostate cancer?

Dr. Scholz: [07:25] Yeah, clinical trials have been done that convincingly show that people that take various minerals like zinc, iron, and copper can accelerate prostate cancer and for people with known prostate cancer, multivitamins can as well. It kind of makes sense if you think about it because prostate cancer cells are very similar to our human cells and are derived from our human body. The very things that help us to grow big and strong (minerals and vitamins, animal protein) all these things can also fortify the cancer and enable it to grow. Unexpectedly, because the prostate cancer cells can grow, just like our human cells can grow, they need minerals and vitamins to grow more quickly. Depriving the cancer cells of these substances, retards cancer growth, giving extra amounts can accelerate the growth of the cancer. People oftentimes are taking these supplements because they think it will strengthen their immune system. Strengthening the immune system, of course, it's a very important and good thing, but oftentimes the cancer cells are flying under the radar of the immune system. It's not a weak immune system, it's a blind immune system. So some new pharmaceuticals coming out in the future that are going to awaken the immune system to attack cancer cells, but in the meantime, these multivitamins and minerals are probably doing more harm than good.

Liz: [08:52] A couple of these are zinc, iron, and copper, but my question is: Zinc is something we take for a common cold, should prostate cancer patients avoid that entirely, or is it okay in small doses?

Liz: [09:52] So we've mentioned a lot of things that don't necessarily work. But there are things that work and again, Dr. Scholz and I both referenced The Supplement Handbook by Dr. Mark Moyad. The subtitle is A Trusted Experts Guide to What Works and What's Worthless for More Than 100 Conditions. So this book was really, really helpful, and I'm sure if you get it, it'll help you too. One thing Dr. Moyad mentioned in the prostate cancer section were statin drugs and Metformin.

Dr. Scholz: [10:25] Yeah, someday, I hope we have a pill for exercise, but statins and Metformin think of them as pills for diet. No one likes to exercise and no one likes to diet, but statin drugs and Metformin mimic the effects of the diet on the human metabolism. Stains drugs by lowering cholesterol levels, Metformin by lowering insulin levels. Both of these medicines are relatively safe. Of course they need to be supervised and your blood tests need to be followed to make sure there's no side effects. But as everyone knows these are used very commonly for heart disease and diabetes, so there's broad familiarity with these substances. The studies have shown that statin drugs and Metformin are useful for prostate cancer patients have been done in men with High-Risk prostate cancer, Gleason 9, or 10, or 8 and undergoing radiation. Studies that were performed comparing outcomes for men that have radiation for High-Risk prostate cancer and those that are taking statin drugs and/or Metformin show improved survival in the men that are taking those pills compared to the ones that don't. So it seems like a good trade off—they're relatively inexpensive, easily accessible, and generally well tolerated. The preliminary data, these are not randomized prospective trials, but the preliminary data does look quite intriguing.

Liz: [11:51] Another thing Dr. Moyad mentioned is red yeast rice. This needs a couple more trials, but it does work like a statin.

Dr. Scholz: [12:00] Yeah, it does. One of the problems with supplements in general is that cancer doctors, such as myself, are really not looking for halfway measures. We want to find the most potent and efficacious agents. One of the nice things about supplements is that they typically don't have much in the way of side effects. That's a beautiful thing. On the other hand, oftentimes they're not nearly as potent as what prescription pharmaceuticals can accomplish. So if you look at red rice yeast, the potency compared to a common cholesterol drug, like Lipitor is probably about 10 to 20% of Lipitor. So instead of taking 10 milligrams of Lipitor, you're taking one milligram of Lipitor. For totally healthy people that are just fine tuning, and don't want to go see a doctor, red rice yeast is great but if you're trying to squeeze the maximum juice out of the orange for getting cured of High-Risk prostate cancer, I would probably go towards a statin drug rather than red rice yeast.

Liz: [12:59] One of Dr. Moyad’s key phrases, he says this a lot at PCRI conferences and it's also in this book is heart healthy is prostate healthy. One drug he mentioned for this is aspirin.

Dr. Scholz: [13:11] So baby aspirin was given almost universally in tele trial in the New England Journal of Medicine came out a couple of years ago showing really no improvement in overall outcome in the general population without any heart disease. So taking it, or putting it in the water, or everyone taking it, doesn't make any sense, but people that have heart disease and people that have High-Risk prostate cancer do appear to benefit by taking a baby aspirin. The method of action is purely speculative, but one of the scary and dangerous things about cancers of course, is that they can spread and it's possible because aspirin is a mild anticoagulant that it makes it more difficult for cancer cells to get out of the prostate, to land, put down roots, and grow in other parts of the body. So for whatever reason, just as is the case for statin drugs and Metformin, baby aspirin seems to, in fact, any dose of aspirin seems to reduce the risk of relapse in people undergoing radiation for High-Risk prostate cancer.

Liz: [14:13] Two vitamins and supplements I hear you talk to your patients a lot about are vitamin D and calcium.

Dr. Scholz: [14:20] This comes up because we give hormone therapy to some of our prostate cancer patients, which causes accelerated calcium loss from the bones and osteoporosis. When osteoporosis gets out of hand, people can have a bone fractures. So vitamin D is fascinating because a number of years ago, large clinical trials looked at adding super high-dose vitamin D to chemotherapy called Taxotere. Preliminary trials, once again, showed that it would likely prolonged survival and increased the anticancer effects of the chemotherapy. Unfortunately, that trial didn't pan out. It might've been due to poor trial design, not through the fact that vitamin D failed, but beyond the fact that vitamin D can treat prostate cancer, there are a lot of reasons to consider its usefulness: to build bones, not just men with low testosterone develop osteoporosis, but all aging people do. Calcium is usually given at the same time. Now calcium is pretty high in our diets already. So calcium deficiency is not common, but if people want to take small doses of calcium, it's important to remember to take it in the evening because your bone metabolism, your bone remodeling, occurs at night while you're sleeping. If you take your calcium in the morning, it'll just be urinated out during the day and have little, if any impact. Studies have shown that super high doses of calcium can be deleterious for prostate cancer patients. Taking grams and grams of calcium every day in men that have advanced prostate cancer actually accelerated mortality. So calcium should be used judiciously in small doses, probably at bedtime. Vitamin D blood levels can be tested, and that's the best way to guide appropriate dosing. People often start with a thousand units a day and then see, after a few months, what the blood levels have arrived at. It takes about three months for vitamin D levels to equilibrate in the blood.

Liz: [16:22] So you can have too much of a good thing. So while you're doing these things, it's important to partner with your doctor and make sure that you're doing everything safely and that it is helping. You can actually get a lot of your vitamins just from eating a healthy diet. How else can diet impact prostate cancer, Dr. Scholz?

Dr. Scholz: [16:42] Well, earlier we talked about how we can monitor PSA levels monthly in men that had previous surgery and are facing a relapse. The same measuring methodology can be used for people who change their diet. I've had a number of patients come to me through the years, not at my recommendation, but who wanted to go on a diet and see how powerful that would be for inhibiting cancer progression. Typically they would pick very stringent, vegetarian diets, macrobiotic diets, lose weight as a result, although that wasn't the goal, and lo and behold PSA levels that were previously rising steadily would stabilize and stop rising for as long as they were carefully following their diets. It didn't make the cancer go away, but it's certainly slowed down its growth.

Liz: [17:33] Well, let's say you have a patient who's on a vegan diet, has a healthy weight, is taking the right amount of the correct supplements. Like will they not get prostate cancer, or if they have prostate cancer, will it prevent it from being aggressive?

Dr. Scholz: [17:50] My personal belief, which is all we can really go on, is that those good practices will reduce the incidence of prostate cancer and they will inhibit the prostate cancers that do occur and postpone their development. I don't think we can point to any one magic methodology to ensure that we won't get any kind of health problem including cancer, but I think we can definitely reduce our risk.

Liz: [18:18] Where's the line between going too far with all of this and also not trying enough?

Dr. Scholz: [18:25] Well, the most stark examples I've had are patients who've come to me for consultation and then made a decision to move to Mexico and undergo regular treatment with coffee enemas. The idea that alternative medicine is on par with what modern technology can offer is rather ridiculous. I see these supplements and diet and exercise as ancillary to all the other available treatments. Not to say that standard treatments can't be overused and incur unnecessary toxicity, everything has to be done skillfully, but I think it's the either or thinking that some people adopt that can really hurt them.

Liz: [19:12] So when you're in a consult and someone brings up supplements, what do you say?

Dr. Scholz: [19:17] Well, oftentimes it's a matter of cutting back because if people have a real prostate cancer, of course, many people have innocuous, prostate cancers and their dietary and supplement behavior may not matter that much for small Gleason 6 prostate cancer, but for people that have the higher grade cancers the usual policy is to warn them that they're multivitamin, multi-mineral preparations may be actually enhancing cancer growth. Just as we would advise them to stay away from fatty foods and high protein, animal protein based diets, which could also accelerate cancer growth.

Liz: [19:58] As you can imagine, this is a huge topic. For instance, Dr. Moyad’s book is about 500 pages and only about a page and a half of that is about prostate cancer. What we focus on is individualized care, treating the whole patient. We've been focusing on just prostate cancer today, but there are supplements for fatigue, for nausea, for men's health. The list goes on and on.

Dr. Scholz: [20:23] So one thing we've learned today is that some supplements and excess minerals can be deleterious. Another thing we've learned is that you need to have clinical trials to back up what you're recommending. The third thing is that supplements tend to be milder than normal medicines and have fewer side effects, but may not have the same horsepower. A good illustration of this is a problem that occurred more than 10 years ago with a supplement called PC-SPES which was some sort of herbal derivative that had estrogenic activity, a combination of Chinese herbs. Lo and behold, this supplement could really cause PSA declines and maintain them. What was also seen is that testosterone levels dropped, breast enlargement occurred, and some men developed blood clots. I think this illustrates that things that are really going to move the needle in treating cancer are going to also have a potential for side effects. The day when we have something that will kill all cancer without any side effects would be truly miraculous. As of now that day hasn't arrived.

Liz: [21:38] This was a really great topic. I learned so much in researching this. Next time we're going to talk about testosterone, a little bit about testosterone replacement, and maybe about testosterone using testosterone in patient’s partners. Thank you for listening. Remember to subscribe, rate, and review on Apple Podcasts and visit our website at podcast.prostateoncology.com.

What do men do when they have no other options? What if they don’t like the side effects? Mainstream, standard of care medicine may not always have the answer. Using off-label therapies can allow men with prostate cancer to find new ways to manage their cancer. PROSTATE PROS talks about unapproved use for approved drugs that may benefit men with prostate cancer.

Dr. Scholz:    [00:03] We’re guiding you to treatment success and avoiding prostate cancer pitfalls.  I’m your host, Dr. Mark Scholz.

Liz:      [00:08] And I'm your cohost, Liz Graves. 

Dr. Scholz:      [00:13] Welcome to the PROSTATE PROS podcast. 

Liz:      [00:20] In past episodes we've covered a variety of options for men with prostate cancer.  This episode, we're going to consolidate some effective options that are not yet FDA approved. 

Dr. Scholz:      [00:31] Liz, as you know, we've been doing this a long time and because we only see one type of cancer, we've learned some tricks along the way.  I don't think you're going to find these things in books, or at least if you do find it in books, it's going to be mentioned in passing without much context.  I think back when I was volunteering over at USC to teach fellows in cancer, back in 1996 and Taxotere, which is one of the most effective medicines for advanced prostate cancer was just released for the treatment of lung cancer.  People were getting amazing responses from men who had lung cancer that had spread to their bones.  When I heard “bones,” of course, a light bulb went off in my head and I thought, “This might work for our prostate cancer patients.”  Indeed we found that it did.  Early reports from other practices were also showing effectiveness.  Interestingly, it wasn't until six or seven years later that the FDA finally approved Taxotere for prostate cancer.  Throughout those years, we were using Taxotere regularly with good results, but it was not an approved therapy. 

Liz:      [01:41] When I was researching for this episode, it was really hard for me to find information about this.  You Google “off-label therapy, alternative medicine,” there are tons of ads you can't really figure it out, “how would I know if a lung cancer drug would work for prostate cancer?”  How do people find this information? 

Dr. Scholz:      [02:01] I think this is sort of insider knowledge.  There are specialists throughout the country that narrowly treat one type of disease.  They talk and they meet at meetings and they share their insights.  In a clinic where there's a high volume of patients, you can quickly determine if something actually works.  You’ll know, within a few months, usually within three or four weeks even, after you start Taxotere, if the PSA is dropping and the bone scans are improving.  It is insider knowledge and it doesn't get published unfortunately, sometimes for years.  There were small phase two trials coming out about Taxotere, but it took six or seven years before the phase three trials led to FDA approval of Taxotere and prostate cancer. 

Liz:      [02:49] So this can be frustrating for patients because there are patients who are starting to run out of options, or maybe they're not liking the side effect profile and they really need to find these alternative options. 

Dr. Scholz:      [03:02] Yeah, of course the online forums are really helpful for patients and the internet is a great resource.  To illustrate, we've had patients that couldn't tolerate every three week Taxotere.  I remember a patient who came to me with the PSA over a thousand and we gave him a standard Q3 week dose of Taxotere, 70 mg/m2.   He just felt so terrible that he refused to take any further treatment.  We finally talked him into taking a much smaller dose on a weekly basis, which was not in the original format for the way Taxotere is used.  Quite surprisingly, he tolerated that nicely.  His PSA ended up dropping down to less than one, he had a multiyear remission, and unfortunately down the line developed colon cancer and passed away from that.  He survived his prostate cancer for many years.  So again, weekly Taxotere in small doses for men that can't seem to tolerate the larger doses is something that's not talked about much anymore, but is just as effective as getting the larger dose every three weeks. 

Liz:      [04:16] What other types of drugs are you using in an off-label way? 

Dr. Scholz:      [04:20] Well, until recently we were using Olaparib, which is a BRCA medicine approved for ovarian cancer, but thankfully the FDA just approved Olaparib.  This is now available for people that have the BRCA mutation.  Another medicine that is, I think, widely known in inner circles in prostate cancer is a medicine called Carboplatin.  It's an injectable type of chemotherapy that's FDA approved for the treatment of lung cancer.  It synergizes with Taxotere and Taxotere’s cousin, Jevtana.  We've seen a number of men who have become resistant to Taxotere when they have Carboplatin added in small, weekly doses, couple hundred milligrams, turn around and respond again.  Quality of life is good, usually it's a weekly or every other week infusion.  So these medicines are effective, but you may not hear about them.  It's certainly not something that's quote, FDA approved and it flies under the radar. 

Liz:      [05:28] Off-label drugs can be drugs used that are already approved for other cancers, or they can be drugs that are approved for a different stage of the same cancer.  Can you talk a little bit about how Zytiga and Xtandi can be used in an off-label way? 

Dr. Scholz:      [05:44] So both of those medicines are FDA approved for men with more advanced stages of prostate cancer.  They're both well tolerated and they're certainly effective.  It's an artifice, the way the FDA approves drugs for one stage of a disease and then refuses to approve it for another stage until studies prove that it's effective.  It's the same disease, we know it's going to be effective.  So men that have what we call High-Risk prostate cancer, in my Key to Prostate Cancer book, we talk about the AZURE stage.  These are men that have Gleason 8 or 9, PSA is above 20, or maybe seminal vesicle invasion or lymph node spread, serious cancer, but Zytiga or Xtandi, oral medicines that are commonly used for advanced prostate cancer, are sometimes covered by insurance sometimes not because it's called off-label.  These medicines are known to be effective against very advanced cancer.  Why wouldn't they be effective against an earlier stage of a more serious type of cancer?  So we often talk with our patients who are usually getting treatment with radiation and Lupron for 12 months, sort of 12 to 18 months, sort of a standard approach.  Why wouldn't we give the best available hormone medicine, which is either Xtandi or Zytiga to enhance the cure rates?  Studies are ongoing and perhaps sometime in the future, this will be the standard approach, but right now it's considered off-label. 

Liz:      [07:16] So off-label drugs deviate from the standard of care.  The standard of care is how all of the insurance companies know what drugs can be paid for certain patients.  The standard of care is determined by the NCCN guidelines.  These are consensus driven management to ensure that all patients get optimal outcomes.  So insurance companies look at those and decide, “Yes, we will pay for this specific medicine and this specific patient.” 

Dr. Scholz:      [07:48] Yes, doctors follow these criteria as well.  The general oncologists are getting so busy with over a hundred different cancers.  They really need guidelines to know what the next step is.  If one medicine stops working, what should they do to follow?  These guidelines then become sort of like the Bible and thinking outside the box sometimes is discouraged even in clinical circles. 

Liz:      [08:17] In a previous podcast episode, we talked about High-Risk prostate cancer and a couple of things that are not chemotherapy that we talked about in an off-label way are Metformin and statins. 

Dr. Scholz:      [08:29] Yeah, I'm glad you brought that up, Liz, because these medicines are really relatively nontoxic.  It's unusual for people to have to stop them because of side effects.  The studies that have been done aren't phase three studies, but the phase two studies that exist seem to show a big advantage.  For some reason, Metformin, which is FDA approved for the treatment of blood sugar issues, and the statin drugs like LIPITOR and CRESTOR, which are FDA approved for people with high cholesterol also seem to give better outcomes when it's combined with hormone therapy and radiation. Another issue, that's not going to come up as standard fare.  If I was in this sort of a situation with High-Risk prostate cancer, I would make sure I was taking these medicines until proven otherwise.  They're affordable and they're nontoxic. 

Liz:      [09:21] One thing I did find in my research was about clinical trials.  Clinical trials can be really difficult to get into, but if you look into them and you find a drug that's being used, even if you're not eligible to use it, it can be a great place to start talking about with your doctor, because clinical trials are researching other FDA approved drugs, which means your doctor can write a prescription for the drug without you having to be involved in the clinical trial.  For those of you who are eligible for clinical trials, that's easy access to get off-label drugs.  One drug that's in a ton of clinical trials right now is KEYTRUDA, but I hear you all the time prescribing this to patients, what's going on? 

Dr. Scholz:      [10:12] KEYTRUDA is the miraculous medicine that kept President Carter alive after his melanoma had spread to the brain.  When you talk about clinical trials, Merck Pharmaceuticals is studying it in probably 10 to 20 different cancer types, including prostate cancer.  But Merck has been very generous in distributing this same medicine on a compassionate use basis, which means that we only have to ask Merck Pharmaceuticals for the drug and they provide it free of charge.  This is no small thing, it's a very, very expensive medicine.  KEYTRUDA is an immune stimulating medicine. It’s infused every three weeks and has activity in prostate cancer.  It’s not yet FDA approved, but we have performed our own phase two trial.  About half the patients seem to either get PSA stabilization or decline.  It's a fascinating medicine because it works by stimulating the immune system and in some patients that effect continues even after the medicine is discontinued. 

Liz:      [11:17] If you want to learn more about KEYTRUDA, listen to our episode about immunotherapy.

Dr. Scholz:      [11:23] While we're talking about immune therapies, we should also cover Leukine, which is GM-CSF a medicine that was originally FDA approved to help people getting chemotherapy keep their immune systems strong.  Over time it was noted that some people were getting declines in PSA with this medicine.  Dr. Eric Small up at UCLA did some of the early phase two trials.  Leukine was also very popular with Charles Snuffy Myers, who is a prostate maven who retired a couple of years ago. Leukine is given by an injection like an insulin shot.  We do it three times a week and it oftentimes has no side effects at all.  It may cause some chills or some rashes sometimes, but for men that have rising PSA after surgery and are really reluctant to do hormone therapy or radiation, Leukine has achieved stabilization of PSA sometimes for years.  I don't think it will ever get FDA approved, but it is something to think about for men that have rising PSA in what we call the INDIGO category that are really reluctant to consider using Lupron or Firmagon. 

Liz:      [12:34] Dr. Scholz, it sounds like you're very creative with all of this and you have a lot of experience seeing patients and offering these options, but what do patients do that can't come see you? 

Dr. Scholz:      [12:45] I think the safest thing is to visit a reputable university center where they're doing clinical trials.  This is where a lot of the new medicines are developed and the universities have institutional review boards to make sure that what they're doing is ethical.  The problem with the universities is sometimes they're constrained by only those clinical trials.  So if you don't fit the profile of their exact clinical trial that they're offering, they may feel a little nervous about offering you something creative, but the oversight and the professional collegiality that's at the universities generally leads to a cut above in the physician quality.  Of course they do have access to some of these new medicines that aren't FDA approved yet.    

Liz:      [13:38] You can search clinicaltrials.gov to find these trials going on and find a way to search for more off-label options.  The logical next topic to follow this up with are alternative, integrative, and natural options.  But as we're running out of time, we'll talk about it on the next episode.  If you have any questions about alternative therapies, you still have time to email us before the next podcast.  You can send your questions to [email protected].  Remember to help us out by rating, reviewing, and subscribing on Apple Podcasts.  

Alex:      [13:41] Hi everyone.  This is Alex with the Prostate Cancer Research Institute.  Every year we host our prostate cancer patients and caregivers conference.  Usually that is in person, but this year it's going to be virtual and free.  On September 11th and 12th we will have prostate cancer experts speaking on treatments, side effects, and lifestyle issues.  There will be live Q & A with our doctors and our helpline team, as well as awesome giveaways.   Visit our website, pcri.org to RSVP today.