Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria: * Written informed consent (IC) obtained. * Male aged ≥ 18 years. * Histologically or cytologically confirmed adenocarcinoma of prostate. * Ongoing GnRH agonist or antagonist therapy, or after bilateral orchiectomy. * Progressive metastatic disease * Adequate bone marrow, hepatic, and renal function * Acceptable and regular bowel movements without any GI disorder or procedure which may interfere with absorption of study treatment * Ability to swallow study treatments Exclusion Criteria: * History of pituitary or adrenal dysfunction. * Known brain metastases. * Active infection or other medical condition that would make prednisone (corticosteroid) contraindicated. * Uncontrolled hypertension * Clinically significant heart disease * Prolonged QTc interval