Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Inclusion Criteria:

   - Histologically or cytologically confirmed adenocarcinoma of prostate.

   - Metastatic disease

   - Candidates for ADT and docetaxel.

   - Started ADT with or without first generation anti androgen, but no longer than 12
   weeks before randomization

   - An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

   - Adequate bone marrow, liver and renal function

Exclusion Criteria:

   - Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor
   (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other
   investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or
   oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or
   immunotherapy for prostate cancer prior to randomization.

   - Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.

   - Had any of the following within 6 months before randomization: stroke, myocardial
   infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
   congestive heart failure (New York Heart Association Class III or IV)

   - Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of
   skin or superficial bladder cancer that has not spread behind the connective tissue
   layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which
   treatment has been completed 5 years before randomization and from which the subject
   has been disease-free

   - Gastrointestinal disorder or procedure which is expected to interfere significantly
   with absorption of study treatment.

   - Inability to swallow oral medications