RecruitingPhase 2NCT05327647

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

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


Sponsor

CHU de Quebec-Universite Laval

Enrollment

160 participants

Start Date

Jun 23, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding bicalutamide — a hormone-blocking medication — to standard BCG bladder therapy can improve outcomes for men with non-muscle-invasive bladder cancer. **You may be eligible if...** - You are a male aged 18 or older - You have been diagnosed with non-muscle-invasive bladder cancer confirmed by biopsy - Your urologist has recommended a course of BCG (immunotherapy placed into the bladder) **You may NOT be eligible if...** - You have received BCG treatment within the last 5 years - You had a heart attack or were hospitalized for heart failure in the past 12 months - You have uncontrolled high blood pressure - You have liver disease with significantly elevated liver enzymes - You are on androgen replacement therapy or being treated for prostate cancer with hormonal therapy - You are taking the blood thinner warfarin (Coumadin) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBicalutamide

Induction intravesical BCG with bicalutamide 150 mg for 90 days

BIOLOGICALControl Arm

Induction BCG


Locations(7)

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

View Full Details on ClinicalTrials.gov

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NCT05327647


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