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

Inclusion Criteria:

1. Males, age 18 or greater.

2. Patients with histologically confirmed non-muscle invasive urothelial carcinoma.

3. Patients have been recommended for a course of intravesical BCG induction treatmentby their urologist

4. Patients who received gemcitabine, epirubicin or mitomycin C instillationsimmediately post-operatively will be eligible for enrollment.

5. Patients with partners of child-bearing potential must agree to 2 acceptable formsof birth control and be continued for at least 3 months after study drug isdiscontinued.

Exclusion Criteria:

1. Patients who have received induction BCG therapy within the last 5 years will beineligible for enrolment.

2. Patients with a history of myocardial infarction or hospital admission for heartfailure within the previous 12 months or who have unstable cardiovascular statuswill be ineligible for enrolment.

3. Patients who have uncontrolled hypertension (for our purposes, defined as thosehaving a systolic blood pressure > 160 documented on 2 occasions despite appropriatemedical therapy) will similarly be ineligible.

4. Patients with a history of liver disease whose hepatic enzymes, alkaline phosphataseor bilirubin are greater than twice the upper limit of normal will be ineligible.

5. Patients with clinical hypogonadism, those on androgen replacement therapy, or thosewith prostate cancer or other diseases treated with systemic hormonal therapy willbe 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 canbe anticipated to decrease their 2-year survival or BCa treatment plan will beineligible.

7. Patients taking an investigational drug within 2 weeks of enrolment into this studywill be ineligible.

8. Patients receiving or planning to receive coumadin therapy will be ineligible.