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.
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 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 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 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.
CHU de Quebec-Universite Laval
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Cancer Research Society
Collaborator