Status:
RECRUITING
A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Lead Sponsor:
CHU de Quebec-Universite Laval
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Cancer Research Society
Conditions:
Non-Muscle Invasive Bladder Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- Males, age 18 or greater.
- Patients with histologically confirmed non-muscle invasive urothelial carcinoma.
- Patients have been recommended for a course of intravesical BCG induction treatment by their urologist
- Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.
- Patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 3 months after study drug is discontinued.
Exclusion
- Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment.
- Patients with a history of myocardial infarction or hospital admission for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment.
- Patients who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure \> 160 documented on 2 occasions despite appropriate medical therapy) will similarly be ineligible.
- Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible.
- Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with systemic hormonal therapy will be ineligible for study enrolment. Patients receiving 5ARIs will not be excluded.
- Patients who have cancer treatment ongoing or planned in the near future which can be anticipated to decrease their 2-year survival or BCa treatment plan will be ineligible.
- Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible.
- Patients receiving or planning to receive coumadin therapy will be ineligible.
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05327647
Start Date
June 23 2022
End Date
December 31 2026
Last Update
December 18 2025
Active Locations (7)
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1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
2
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
3
Centre intégré de santé et services sociaux de Chaudière Appalaches
Lévis, Quebec, Canada, G6V3Z1
4
Centre Hospitalier de l'Université De Montréal_CHUM
Montreal, Quebec, Canada, H2X 3E4