Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Not Recruiting

Trial ID: NCT02799602


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.

Official Title

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

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

Alice C. Fan
Alice C. Fan

Associate Professor of Medicine (Oncology) and, by courtesy, of Urology


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


drug: BAY1841788 / darolutamide (ODM-201)

drug: Standard ADT (androgen deprivation therapy)

drug: Docetaxel

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shermeen Poushnejad

New Trial Alerts