Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine
differentiation or small cell features

- Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy

- Progressive disease despite androgen deprivation therapy as defined by rising PSA
levels or progressive soft tissue or bony disease

- No prior treatment with cytotoxic chemotherapy

- Asymptomatic or mildly symptomatic from prostate cancer

Exclusion Criteria:

- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
Investigator, would make the patient inappropriate for enrollment

- Known or suspected brain metastasis or active leptomeningeal disease

- History of another malignancy within the previous 5 years other than curatively
treated non-melanomatous skin cancer