Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Inclusion Criteria:

   - Histologically or cytologically confirmed adenocarcinoma of the prostate

   - Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH)
   analogue (agonist or antagonist) or orchiectomy

   - At least one prior chemotherapy regimen for metastatic castration-resistant prostate
   cancer with at least one regimen containing docetaxel

   - Progressive disease as evidenced by prostate specific antigen (PSA) rise or
   radiographic or clinical worsening of disease

   - No known or suspected brain metastasis

   - There is no comparable or satisfactory alternative therapy to treat the subject's
   disease

   - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

   - History of seizure or any condition that may predispose to seizure including, but not
   limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or
   alcoholism

   - History of loss of consciousness or transient ischemic attack within the last 12
   months

   - Clinically significant cardiovascular disease

   - Following lab values:

      - Absolute neutrophil count is <1,000/µL

      - Platelet count is <50,000/µL

      - Hemoglobin is < 5.6 mmol/L (9 g/dL)

      - Total bilirubin ≥1.5 x upper limit of normal (ULN)

      - Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2.5 x ULN

      - Creatinine clearance is less than 30 ml/min by the Cockcroft and Gault formula

   - Subject's conditions suggests that a bone fracture or complication of a bone fracture
   (such as compression of the spinal cord or other nerves) is likely to occur very soon

   - Subject has participated in a previous clinical study of MDV3100 for which the primary
   endpoint has not yet been reported (e.g., the PREVAIL trial)