Rockledge

Researchers are evaluating the effects of adding gemcitabine, a chemotherapy drug, to the usual intravesical Bacillus Calmette Guerin (BCG) treatment for patients with recurrent non-muscle invasive bladder cancer (NMIBC). This phase III trial aims to compare how well gemcitabine combined with BCG works versus BCG alone in preventing high-grade cancer recurrence and progression in patients whose cancer has returned after prior BCG therapy. Participants are randomly assigned to one of two treatment groups. One group receives BCG alone intravesically once a week for 6 weeks, followed by maintenance BCG treatments at months 3, 6, and 12 if there is no disease progression or toxicity. The other group receives gemcitabine intravesically on a scheduled basis combined with BCG on alternate weeks during the initial treatment phase and maintenance phases at months 3, 6, and 12. Both groups undergo bladder biopsy, transurethral resection of bladder tumor (TURBT), cystoscopy, CT or MRI scans, and blood and urine sample collection throughout the study. After completing treatment, participants are followed every 3 months for 2 years, then every 6 months for up to 5 years from randomization. Researchers will monitor high-grade recurrence-free survival as the primary outcome, along with measures such as cancer-free status at 3 months, 6-month complete response, progression-free survival, cystectomy-free survival, and safety including adverse events. Biobanking of tissue and samples will support future research. The study collects extensive clinical and imaging data to evaluate the treatments over time.