Inclusion Criteria:

- Patients with adenocarcinoma of the prostate

- Subjects with locally advanced, and/or metastatic prostate cancer for whom surgical
castration or other medical interventions are not considered appropriate or
acceptable

Exclusion Criteria:

- Any known history of abnormal liver function tests

- Any severe concomitant condition that would make it undesirable, in the clinician's
opinion, for the subject to participate in the trial.

- Known hypersensitivity to bicalutamide or any of the components found in bicalutamide