Safety and Pharmacokinetics 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.
Part 2: Identified activating mutation in the LBD of AR in plasma ctDNA confirmed by the central testing.

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.