Ep. 320 Gem-iDRS for BCG Unresponsive Bladder Cancer: A Deep Dive with Dr. Sarah Psutka

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. --- Get the BackTable app https://www.backtable.com/app --- This podcast is supported by Johnson & Johnson https://www.inlexzohcp.com/ --- Timestamps 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 --- More about this episode 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. --- Resources 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 --- BackTable Urology is the go-to podcast for urologists, urologic oncologists, and urogynecologists. Download the free BackTable app to get early access to new episodes, cases, and courses curated by physicians in your specialty. ► https://www.backtable.com/app