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 apphttps://www.backtable.com/app --- This podcast is supported by Johnson & Johnson https://www.inlexzohcp.com/ --- Timestamps 00:00 - Introduction02:40 - Why Focus on TAR-20005:35 - Device Basics07:05 - Dosing Schedule Explained11:17 - SUNRISE-01 Trial Results15:07 - Patient Selection and Contraindications20:52 - Indications for Device Removal23:26 - Clinic Workflow Learning Curve25:56 - Tips for Insertion and Device Deployment28:52 - Cystoscopy Findings and Surveillance Protocol32:16 - Treatment Sequencing38:43 - Future Trial and Research Directions45:16 - Biomarkers, AI, and Personalizing Care46:35 - Cost, Supportive Care, and Patient Burden48:42 - 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 Studyhttps://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 Resultshttps://ascopubs.org/doi/10.1200/JCO-25-02382 INLEXZO - SunRISe-3 Studyhttps://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