ARASENS A randomized, double-blind, placebo-controlled Phase III study of ODM-201 versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone-sensitive prostate cancer
The purpose of the study is to assess the efficacy and safety of BAY1841788 (ODM-201) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
Key Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of prostate.
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
Yoshio Inoue, M.D.
- Providence Regional Cancer Partnership - Everett