A Multicenter, Single-arm, Open Label Treatment Protocol to 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)