CRC_17777

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.

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
Phase III
NCT02799602
Cancer
Genitourinary
Yoshio Inoue, M.D.
Bayer
Virginia Sanchez
  • Providence Regional Cancer Partnership - Everett