Can a drug-eluting bladder device change the treatment algorithm for BCG-unresponsive non–muscle invasive bladder cancer (NMIBC)? In this episode of BackTable Urology, Dr. Ruchi Talwar interviews Dr. Sarah Psutka to explore the emerging role of a novel intravesical device that delivers sustained gemcitabine therapy for patients refusing or ineligible for cystectomy. They highlight new FDA-approved treatment options, real-world workflow considerations, and the clinical potential for continuous intravesical chemotherapy in a crowded therapeutic landscape.
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00:00 - Introduction
02:40 - Why Focus on TAR-200
05:35 - Device Basics
07:05 - Dosing Schedule Explained
11:17 - SUNRISE-01 Trial Results
15:07 - Patient Selection and Contraindications
20:52 - Indications for Device Removal
23:26 - Clinic Workflow Learning Curve
25:56 - Tips for Insertion and Device Deployment
28:52 - Cystoscopy Findings and Surveillance Protocol
32:16 - Treatment Sequencing
38:43 - Future Trial and Research Directions
45:16 - Biomarkers, AI, and Personalizing Care
46:35 - Cost, Supportive Care, and Patient Burden
48:42 - Closing Thoughts
The conversation dives into patient selection, preparation, and side effect management for TAR-200, as well as the key findings from the SUNRISE-01 trial. Dr. Psutka discusses dosing schedules, when to remove the device, and how to handle complications like UTI, hematuria, and LUTS. The episode also covers surveillance protocols, the impact on clinic operations, and the importance of balancing vigilant cancer surveillance with patient burden. Finally, they touch on future directions, including biomarkers, AI-assisted pathology, and optimizing the timing of cystectomy and supportive care for a more personalized approach to NMIBC.
TAR-200 for Bacillus Calmette-Guérin–Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study
https://ascopubs.org/doi/10.1200/JCO-25-01651
SUO 2024: SunRISe-5: A Phase III, Randomized, Open-label Study of TAR-200 Compared with Intravesical Chemotherapy After Bacillus Calmette-Guerin in Recurrent, High-risk, Non-muscle Invasive Bladder Cancer
SUO 2024: SunRISe-5: A Phase III, Randomized, Open-label Study of TAR-200 Compared with Intravesical Chemotherapy After Bacillus Calmette-Guerin in Recurrent, High-risk, Non-mushttps://www.urotoday.com/conference-highlights/suo-2024/suo-2024-bladder-cancer/156723-suo-2024-sunrise-5-a-phase-iii-randomized-open-label-study-of-tar-200-compared-with-intravesical-chemotherapy-after-bacillus-calmette-guerin-in-recurrent-high-risk-non-muscle-invasive-bladder-cancer.htmlcle Invasive Bladder Cancer
Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results
https://ascopubs.org/doi/10.1200/JCO-25-02382
INLEXZO - SunRISe-3 Study
https://www.jnjmedicalconnect.com/products/inlexzo/medical-content/inlexzo-sunrise-3-study
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