Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

Main Inclusion Criteria: * Written informed consent (IC) obtained. * Male aged ≥ 18 years. * Histologically confirmed adenocarcinoma of the prostate. * Castration resistant prostate cancer with serum testosterone \< 50 ng/dl. * Metastatic disease. * Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy. * Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide). * ECOG performance status 0-1. * Adequate marrow, liver and kidney function. * Able to swallow study treatment. * Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC. Main Exclusion Criteria: * History of pituitary or adrenal dysfunction. * Known brain metastases or active leptomeningeal disease. * Active infection or other medical condition that would make corticosteroid contraindicated. * Poorly controlled diabetes. * Hypotension or uncontrolled hypertension. * Clinically significantly abnormal serum potassium or sodium level. * Active or unstable cardio/cerebro-vascular disease including thromboembolic events. * Prolonged QTcF interval.