Actively Recruiting
A Phase II Randomized Trial of Bicalutamide with Intravesical BCG for Non-muscle Invasive Bladder Cancer
Led by CHU de Quebec-Universite Laval · Updated on 2025-12-18
160
Participants Needed
7
Research Sites
17 weeks
Total Duration
On this page
Sponsors
C
CHU de Quebec-Universite Laval
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
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-Gu erin (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.
CONDITIONS
Brief Title
A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older
- Histologically confirmed non-muscle invasive urothelial carcinoma
- Recommended for intravesical BCG induction treatment by a urologist
- Eligible if received gemcitabine, epirubicin, or mitomycin C instillations immediately after surgery
- Agree to use two acceptable forms of birth control if having a partner of child-bearing potential, continued for at least 3 months after study drug ends
You will not qualify if you...
- Received induction BCG therapy within the last 5 years
- History of myocardial infarction or heart failure hospitalization within the past 12 months or unstable cardiovascular status
- Uncontrolled hypertension with systolic blood pressure over 160 on two occasions despite treatment
- History of liver disease with liver enzymes, alkaline phosphatase, or bilirubin more than twice the upper limit of normal
- Clinical hypogonadism, androgen replacement therapy, prostate cancer, or diseases treated with systemic hormonal therapy (5ARIs allowed)
- Ongoing or planned cancer treatment expected to reduce 2-year survival or interfere with bladder cancer treatment
- Use of investigational drug within 2 weeks prior to study enrollment
- Receiving or planning to receive coumadin therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 3 months
Participants receive daily oral bicalutamide or placebo for 3 months overlapping with 6 cycles of intravesical BCG instillations as part of their treatment for non-muscle invasive bladder cancer.
6 intravesical BCG treatment visits and daily oral medication intake
Duration - Up to 33 months following treatment completion
Participants are monitored for tumor recurrence, progression, urinary symptoms, and quality of life after completing treatment.
Periodic follow-up visits over 3 years
Trial Site Locations
Total: 7 locations
1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
2
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Actively Recruiting
3
Centre intégré de santé et services sociaux de Chaudière Appalaches
Lévis, Quebec, Canada, G6V3Z1
Actively Recruiting
4
Centre Hospitalier de l'Université De Montréal_CHUM
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
5
McGill University Health Centre_CUSM
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
6
CHU de Québec-Université Laval
Québec, Quebec, Canada, G1G 5X1
Actively Recruiting
7
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada, J1H 5H3
Actively Recruiting
Research Team
P
Paul Toren, MD,PhD,FRCSC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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