 Open Label Period 1 At Week 13, all subjects will be assessed by prostate-specific antigen PSA and imaging. Subjects with no confirmed PSA response or evidence of radiographic progression will be ineligible for participation in Period 2 and will typically have safety follow up; however, Period 1 treatment may continue for some subjects as long as the investigator considers it to be of clinical benefit stopping on initiation of any new antineoplastic therapy. Subjects with confirmed PSA response will continue Period 1 until disease progression. 