Using bicalutamide with BCG treatment for bladder cancer

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

This study is testing if adding a drug called bicalutamide to the standard BCG treatment can help people with non-muscle invasive bladder cancer have fewer recurrences of their cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: CHU de Quebec-Universite Laval (Academic / other)
• Locations: 7 sites (London, Ontario and 6 other locations)
• Trial ID: NCT05327647 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial investigates the effectiveness of bicalutamide, an androgen receptor antagonist, in combination with standard intravesical Bacillus Calmette-Guérin (BCG) therapy for patients with non-muscle invasive bladder cancer (NMIBC). The trial consists of two cohorts: one open-label and one double-blind, where participants will receive either bicalutamide or a placebo alongside BCG treatment. The goal is to determine if bicalutamide can reduce the recurrence rate of NMIBC compared to standard BCG treatment alone. The study will last for 36 months, including follow-up visits.

Who should consider this trial

Good fit: Ideal candidates include males aged 18 or older with histologically confirmed non-muscle invasive urothelial carcinoma who are recommended for BCG treatment.

Not a fit: Patients who have received induction BCG therapy within the last 5 years or have unstable cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence rates of non-muscle invasive bladder cancer in patients.

How similar studies have performed: While the use of bicalutamide in this context is novel, previous studies have shown promise in targeting androgen receptors for cancer treatment.

Eligibility criteria

Inclusion Criteria:

1. Males, age 18 or greater.
2. Patients with histologically confirmed non-muscle invasive urothelial carcinoma.
3. Patients have been recommended for a course of intravesical BCG induction treatment by their urologist
4. Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.
5. 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 Criteria:

1. Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible.
8. Patients receiving or planning to receive coumadin therapy will be ineligible.

Where this trial is running

London, Ontario and 6 other locations

• London Health Sciences Centre — London, Ontario, Canada (Recruiting)
• University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
• Centre intégré de santé et services sociaux de Chaudière Appalaches — Lévis, Quebec, Canada (Recruiting)
• Centre Hospitalier de l'Université De Montréal_CHUM — Montreal, Quebec, Canada (Recruiting)
• McGill University Health Centre_CUSM — Montreal, Quebec, Canada (Recruiting)
• CHU de Québec-Université Laval — Québec, Quebec, Canada (Recruiting)
• CIUSSS de l'Estrie - CHUS — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Wassim Kassouf, MDCM,FRCSC — McGill University Health Centre/Research Institute of the McGill University Health Centre
• Study coordinator: Paul Toren, MD,PhD,FRCSC

Conditions Non-Muscle Invasive Bladder Cancer; Bicalutamide; BCG instillation; Placebo