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
Study of Drug in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients with Prostate Cancer
Sponsor: Bayer HealthCare Pharmaceuticals Inc.
Enrolling: Male Patients Only
IRB Number: AAAR0253
U.S. Govt. ID: NCT02799602
Contact: Emerson Lim, MD: 212-305-5098 / el2342@cumc.columbia.edu
Additional Study Information: The purpose of this study is to find out if ODM-201 is effective at keeping hormone-sensitive prostatecancer under control when given in addition to standard treatment which includes androgen deprivation therapy (ADT) and docetaxel chemotherapy for six cycles. A total of approximately 1,300 men will take part in this study at a number of different locations internationally. Subjects will have a 1:1 chance of receiving ODM-201 and a 1:1 chance of receiving placebo. Placebo looks identical to the active drug but does not contain any active drug (a fake treatment). In either case, subjects will receive standard treatment with ADT and docetaxel chemotherapy for six cycles. Subjects will have started ADT before taking part in this study.
This study is closed
Emerson Lim, MD
Do You Qualify?
Have you been diagnosed with prostate cancer? Yes No
Have you had a stroke, heart attack, or congestive heart failure in the past six months? Yes No
Are you able to swallow pills? Yes No
You may be eligible for this study

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For more information, please contact:
Emerson Lim, MD