Study Summary
This trial is testing if adding darolutamide to ADT (a treatment to reduce testosterone levels) is more effective than ADT alone in treating high-risk prostate cancer.
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 9 Secondary · Reporting Duration: From randomization to any of the MFS events, pelvic lymph node recurrence or detectable prostate-specific antigen (PSA) (PSA >= 0.2 ng/mL, confirmed by a second PSA of the same level or higher), whichever occurs first, assessed up to 36 months
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Arm A (ADT, placebo)
1 of 2
Arm B (ADT, darolutamide)
1 of 2
Active Control
Experimental Treatment
810 Total Participants · 2 Treatment Groups
Primary Treatment: Darolutamide · Has Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Male Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:About The Reviewer
Michael Gill - B. Sc.
First Published: October 26th, 2021
Last Reviewed: November 29th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.