Actively Recruiting
A Phase II Trial of Bicalutamide in Patients Receiving 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
236 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
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.
CONDITIONS
Official 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 patients aged 18 years or older
- Histologically confirmed non-muscle invasive urothelial carcinoma
- Recommended for intravesical BCG induction treatment by a urologist
- Patients who received gemcitabine, epirubicin, or mitomycin C instillations immediately post-operatively are eligible
- Patients with partners of child-bearing potential must agree to use two acceptable forms of birth control during and for at least 3 months after study drug discontinuation
You will not qualify if you...
- Received induction BCG therapy within the last 5 years
- History of myocardial infarction or hospital admission for heart failure 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 hepatic enzymes, alkaline phosphatase, or bilirubin over twice the upper limit of normal
- Clinical hypogonadism, androgen replacement therapy, prostate cancer, or other systemic hormonal therapy
- Ongoing or planned cancer treatment expected to reduce 2-year survival or bladder cancer treatment plan
- Taking an investigational drug within 2 weeks before enrollment
- Receiving or planning to receive coumadin therapy
AI-Screening
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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
CONTACT
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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