A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

Condition: Prostatic Neoplasms

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02799602

Sponsor: Bayer

Phase: Phase 3


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov