BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer
Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non-muscle-invasive bladder cancer (NMIBC), but over 30% of people still develop recurrent transitional cell carcinoma (TCC) despite optimal therapy with adjuvant intravesical BCG. Our meta-analysis, including a recent randomised phase 2 trial, suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both Mitomycin (MM) and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase 3 trial using standard techniques for intravesical administration.
Phase:
PHASE3
Details
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Collaborators:
Australian and New Zealand Urogenital and Prostate Cancer Trials Group University of Sydney