ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
Condition: Metastatic Hormone-sensitive Prostate Cancer
MeSH terms: Prostatic Neoplasms; Hypersensitivity
Intervention: BAY1841788 / darolutamide (ODM-201); Standard ADT (androgen deprivation therapy); Docetaxel; Placebo
Intervention description: 600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel; As prescribed by the treating physician.; As prescribed by the treating physician.; Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone [LHRH] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.
Intervention MeSH terms: Docetaxel; Androgens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1306.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide
      (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in
      patients with metastatic hormone sensitive prostate cancer.
    

Eligibility criteria:

        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