Last updated on February 2018

ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Malignant neoplasm of prostate | Prostate Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male
  • Other:
    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

You may not be eligible for this study if the following are true:

  • 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
    kin 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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