Tests bicalutamide alongside BCG treatment for early bladder cancer
Tests bicalutamide with BCG in adults with non-muscle invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
Key facts
- Where
- Lévis, London, Montreal, Québec, Sherbrooke, and Toronto, CanadaSee the 7 sites
- Phase
- Phase 2
Where in Canada
- Centre intégré de santé et services sociaux de Chaudière AppalachesLévis, CanadaTaking people
- London Health Sciences CentreLondon, CanadaTaking people
- Centre Hospitalier de l'Universite de Montreal (CHUM)Montreal, CanadaTaking people
- McGill University Health Centre_CUSMMontreal, CanadaTaking people
- CHU de Quebec-Universite LavalQuébec, CanadaTaking people
- CIUSSS de l'Estrie-CHUSSherbrooke, CanadaTaking people
- University Health Network - Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CHU de Quebec-Universite Laval
- Trial code
- NCT05327647
- Record updated
- 26 October 2026
- Original description
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.Read full original descriptionShow less
A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer
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.
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 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 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; 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 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 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.