Castration-Resistant Prostate Cancer

Inclusion Criteria

- Male subjects aged 18 years or older with histologically confirmed adenocarcinoma of prostate
                - Metastatic disease defined as documented metastasis on bone scan and/or computed tomography (CT) or magnetic resonance imaging (MRI)
                - Progressive disease as defined by any one of the following criteria: a) Rising PSA levels: two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart with the lowest value being ≥ 2 ng/ml. If the third PSA level is less than the second, an additional fourth test to confirm a rising PSA (i.e., the fourth value is ≥ the second value and is ≥ 2 ng/ml) is acceptable; b) Radiographic disease progression based on RECIST 1.1 criteria in subjects with soft-tissue lesions or appearance of 2 or more new lesions on bone scan in subjects with bone disease.
                - Life expectancy at least 6 months
                - Asymptomatic or mildly symptomatic prostate cancer
                - Prior surgical castration or concurrent use of an agent for medical castration (e.g., LHRH analog) with serum testosterone at screening < 50 ng/dl or < 1.7 nmol/l

Exclusion Criteria

- Previous chemotherapy for prostate cancer
                - History of other malignancy within the previous 5 years, except for basal cell carcinoma of skin
                - Prior or concomitant use of any investigational or approved androgen receptor antagonist except for flutamide, bicalutamide or nilutamide
                - Prior or concomitant use of any CYP17 inhibitor (e.g. Abiraterone, TAK-700 or TOK-001), ketoconazole or sipuleucel-T within 4 weeks of start of study treatment