Castration-resistant prostate cancer

- Histologically confirmed adenocarcinoma of the prostate
- Ongoing androgen deprivation therapy (ADT) with a LHRH analogue or antagonist or bilateral orchiectomy and serum testosterone level <50 ng/dL (<0.5 ng/mL, <1.7 nmol/L) at screening
- Progressive metastatic disease during the androgen deprivation and after the treatment with antiandrogen and antiandrogen withdrawal
- The patient had received 1 or 2 chemotherapy treatments, OR was ineligible for chemotherapy, OR was intolerant of chemotherapy, OR had declined chemotherapy, OR had no need for chemotherapy yet.
- The patient had an ECOG performance status of 0-1 at screening.
- The patient had screening liver, renal and albumin values of: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), Total bilirubin ≤ 2 x ULN, Creatinine ≤1.5 x ULN and Albumin > 3.0 g/dL.
- Prior treatment with antiandrogen. Discontinuation of bicalutamide or nilutamide at least 6 weeks and other antiandrogens at least 4 weeks prior to the start of the study treatment.
- Life expectancy of at least 3 months

- Patients who received prior therapy with MDV3100 or any investigational androgen receptor antagonist
- Patients who received chemotherapy, radiotherapy or any experimental therapy within 4 weeks (within 6 weeks for nitrosoureas and mitomycin C) of the start of study treatment or had not recovered to Grade ≤1 or returned to baseline from any acute treatment-related toxicities of the previous therapy except for alopecia and Grade 2 neuropathy
- Therapy with oral ketoconazole or CYP17 inhibitor within 30 days prior to the start of study treatment