Phase II Study of Bicalutamide With Intravesical BCG Treatment in Men with Non-Muscle Invasive Bladder Cancer

What this Trial Is About

Researchers are evaluating treatments for non-muscle invasive bladder cancer NMIBC, the most common form of bladder cancer. This phase II clinical trial compares the standard treatment of intravesical Bacille Calmette-Guerin BCG with a combination of BCG and the drug bicalutamide. The study addresses the issue that 30-40% of patients still experience relapse or disease progression despite standard therapy, exploring whether adding bicalutamide may help reduce recurrence rates. The trial includes two groups cohort A, an open-label group of about 40 patients, and cohort B, a double-blind group with placebo involving approximately 120 patients. In both cohorts, participants receive six cycles of intravesical BCG. Cohort A compares BCG alone to BCG plus daily oral bicalutamide 150 mg for 3 months. Cohort B compares BCG plus bicalutamide to BCG plus a daily oral placebo for 3 months. Participants are involved for 36 months from screening to final follow-up. The study monitors bladder tumor recurrence rates over three years as the primary outcome. Secondary outcomes include tumor progression, number of recurrences, quality of life, and urinary symptoms. Safety and treatment effects are assessed regularly during this period to understand the impact of adding bicalutamide to standard BCG therapy.

A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer