A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
NCT ID: NCT05327647
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2022-06-23
2026-12-31
Brief Summary
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Detailed Description
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The study is composed of two cohort A (open-label, around 40 patients) and B (double-blind, with placebo, around 120 patients).
In the cohort A, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) the standard of care of 6 cycles of intravesical instillation BCG.
In the cohort B, the participants will be randomized to either the treatment with 1) daily intake of 150 mg bicalutamide for 3 months overlapping with the 6 cycles of intravesical instillations of BCG or 2) daily intake of 150mg placebo for 3 months + the standard of care of 6 cycles of intravesical instillation BCG.
The participation in this trial should last 36 months from the screening visit to the last follow-up visit.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Bicalutamide
Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days (in cohort A and cohort B)
Bicalutamide
Induction intravesical BCG with bicalutamide 150 mg for 90 days
Control Arm
cohort A: Induction intravesical Bacille Calmette-Guérin treatment
cohort B: Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral placebo for 90 days
Control Arm
Induction BCG
Interventions
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Bicalutamide
Induction intravesical BCG with bicalutamide 150 mg for 90 days
Control Arm
Induction BCG
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
MALE
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Cancer Research Society
OTHER
CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Principal Investigators
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Paul Toren, MD,PhD,FRCSC
Role: STUDY_CHAIR
CHU de Québec-Université Laval
Wassim Kassouf, MDCM,FRCSC
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Melissa Huynh, MD,MPH,FRCSC
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre, Victoria Hospital
Jean-Baptiste Lattouf, MD,FRCSC
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Montréal (CHUM)
Girish Kulkarni, BSc, MD, PhD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
The Princess Margaret Cancer Foundation
Locations
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London Health Sciences Centre
London, Ontario, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre intégré de santé et services sociaux de Chaudière Appalaches
Lévis, Quebec, Canada
Centre Hospitalier de l'Université De Montréal_CHUM
Montreal, Quebec, Canada
McGill University Health Centre_CUSM
Montreal, Quebec, Canada
CHU de Québec-Université Laval
Québec, Quebec, Canada
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Melissa Huynh, MD
Role: primary
Girish Kulkarni, BSc, MD, PhD, FRCSC
Role: primary
Matthieu Gratton, MD
Role: primary
Jean-Baptiste Lattouf, MD
Role: primary
Wassim Kassouf, MDCM
Role: primary
Paul Toren, MD
Role: primary
Typhaine Gris, PhD
Role: backup
Patrick Richard, MD
Role: primary
Other Identifiers
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MP-20-2022-6318
Identifier Type: -
Identifier Source: org_study_id