Using bicalutamide with BCG treatment for bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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
• Email: paul.toren@crchudequebec.ulaval.ca
• Phone: 418-525-4444

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

  Recruiting Natera, Inc. · Austin, Texas · NCT07763197

• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

  This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.

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• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

  This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.

  Recruiting at 4 sites Phase 2 Tianjin Medical University Second Hospital · Tianjin and 3 other locations · NCT07625527

• Comparing CT and MRI with VI-RADS for Bladder Cancer Staging

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• How bladder microbes and immune signals affect lower urinary tract health

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  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07494864

• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

  This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).

  Recruiting at 14 sites Phase 2 Lepu Biopharma Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07283835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.