A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer

This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at
doses determined to be tolerated. Patients who tolerate the drug and do not progress will be
allowed to continue treatment. The study endpoints are safety and tolerability and
pharmacokinetics. PSA values will also be collected to look for PSA response.

Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the prostate;

2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH)
analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);

3. Progressive disease after medical or surgical castration,

Exclusion Criteria:

1. Metastases in the brain or active epidural disease. (Note: patients with treated
epidural disease are allowed);