Non-inferiority Phase IV Trial of VI-RADS Imaging Followed by Photodynamic TURBT Versus Standard White-light TURBT Plus Repeat TURBT in Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating a new approach for treating non-muscle-invasive bladder cancers (NMIBCs), focusing on avoiding unnecessary second surgeries called repeat transurethral resections of bladder tumors (Re-TURBT). This phase IV, open-label, randomized controlled trial compares a modern imaging-guided surgery using photodynamic diagnosis (PDD-TURBT) after MRI staging with the current standard of care involving white light cystoscopy and mandatory Re-TURBT. The study aims to reduce overtreatment, improve patient quality of life, and lower healthcare costs while ensuring cancer control. Participants will be randomized into two groups: one receiving PDD-TURBT without a second surgery, and the other following standard care with white light TURBT followed by Re-TURBT within 2 to 6 weeks. The PDD-TURBT uses a photosensitizer drug (hexaminolevulinate) inserted into the bladder and special blue light equipment to better detect tumors during surgery. The trial includes a total of 112 participants per arm, with all receiving initial MRI-based VI-RADS scoring to exclude muscle-invasive disease. Throughout the study, participants will undergo regular follow-ups including cystoscopy and imaging to monitor for early bladder cancer recurrence within 4.5 months and later outcomes over three years. Researchers will assess recurrence rates, progression to muscle-invasive cancer, patients' health-related quality of life, and cost effectiveness. The study is designed to provide evidence for potentially updating treatment guidelines and reducing the burden of repeated surgeries for bladder cancer patients.

Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)