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.
Sequential
Bicalutamide
DrugInduction intravesical BCG with bicalutamide 150 mg for 90 days
Control Arm
Biological/VaccineInduction BCG
Rate of bladder tumour recurrence
To time to bladder tumor recurrence compared to the standard of care induction BCG
Incidence of tumour progression
To compare the incidence of tumor progression between the intervention and control arms
Number of tumor recurrences
To compare the overall incidence of tumor recurrences between intervention and control arms
Number of tumours at first recurrence
Evaluation of the number of tumours at first recurrence between the two arms
Quality of life (QLQ-C30)
Evaluation of quality of life with QLQ-C30 questionnaire (EORTC Core Quality of Life questionnaire). The scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom
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CHU de Quebec-Universite Laval
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Cancer Research Society
Collaborator
