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