NCT05327647

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.

Detailed description

Bladder cancer is the second most common urological cancer after prostate cancer. Non-muscle invasive bladder cancer (NIMBC) is the most common form (\~ 75%). The standard treatment involves the use of intravesical instillation of bacillus Calmette-Guérin (BCG). Nonetheless, 30-40% of the patients still relapse or progress. Clinical and laboratory research suggests that medications targeting the androgen receptor, such as bicalutamide, combined with the standard treatment with BCG may decrease the recurrence rate of NMIBC. The study is composed of two cohort A (open-label, around 40 patients) and B (double-blind, with placebo, around 120 patients). In the cohort A, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) the standard of care of 6 cycles of intravesical instillation BCG. In the cohort B, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) daily intake of 150mg placebo for 3 months + the standard of care of 6 cycles of intravesical instillation BCG. The participation in this trial should last 36 months from the screening visit to the last follow-up visit.

Conditions

• Non-Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	Bicalutamide	Induction intravesical BCG with bicalutamide 150 mg for 90 days
BIOLOGICAL	Control Arm	Induction BCG

Timeline

• Start date: 2022-06-23
• Primary completion: 2026-09-01
• Completion: 2026-12-31
• First posted: 2022-04-14
• Last updated: 2025-12-18

Locations

7 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study