Clinical Trial

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It also plays role in prostate cancer development. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with ADT may work better in eliminating or reducing the size of the cancer and/or prevent it from returning compared to ADT alone in patients with prostate cancer.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2026-09-30 -> 2026-06-09 2026-07-29
notable Primary completion pushed: 2026-06-30 -> 2026-09-30 2026-06-30
Trial Details
NCT Number NCT04484818
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions Prostate Carcinoma
Enrollment 27 participants
Start Date 2021-03-01
Primary Completion 2026-06-09 (estimated)
Study Completion 2028-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28