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Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Trial Status: complete
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02799602.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
Massachusetts
Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The
study population will consist of approximately 1300 subjects with metastatic hormone
sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg
(2 x 300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent
to a total daily dose of 1200 mg, in addition to standard androgen deprivation therapy
(ADT) and docetaxel. Subjects will be stratified at randomization for the extent of
disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as
standard therapy. Six cycles of docetaxel will be administered after randomization.
The subjects considered for inclusion in the study will have metastatic prostate cancer
and will be candidates for ADT and docetaxel.
Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic
progressive disease, change of antineoplastic therapy, unacceptable toxicity, until
subject withdraws consent, withdrawal from the study at the discretion of the
investigator or his/her designated associate(s), death, non-compliance, or if sponsor
