Inclusion Criteria:

1. Provision of written informed consent.

2. Men, over 18 years of age, with histologically-confirmed prostate cancer

3. Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1

4. Serum testosterone level < 50 ng/ml

5. Current treatment with bicalutamide 50 mg daily.**

6. Two consecutive rises in PSA above a nadir value, with the absolute value of the
latest PSA > 2.0 ng/ml.

7. Highest PSA level no greater than or equal to 30 ng/ml.

8. Life expectancy of greater than 1 year -

Exclusion Criteria:

1. Patients may not have received prolonged anti-androgen therapy other than with
bicalutamide. Patients who have received short term (2 months or less) non-steroidal
anti-androgen therapy with an agent other than bicalutamide to block flare are not
excluded.*

2. PSA level greater than 30 ng/ml.

3. In the opinion of the investigator, any evidence of severe or uncontrolled systemic
disease which would make it undesirable for the patient to participate in the trial.

4. Subjects who have received prior chemotherapy.

5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or superficial transitional cell carcinoma of
the bladder.

6. Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L.

7. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).

8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5
times the ULRR.

9. Serum creatinine greater than 1.5 times -