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
Trial Description
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 Requirements
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