Clinical Trial

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Study acronym: DASL-HiCaP
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.
Protocol Amendment History 42 amendments
This ClinicalTrials.gov record has been amended 42 times since 2019-10-21; most recent amendment 2026-05-04.
Status change: Recruiting → Active, Not Recruiting 2023-07-26
Status change: Not Yet Recruiting → Recruiting 2020-04-29
Trial Details
NCT Number NCT04136353
Lead Sponsor University of Sydney
Collaborators: Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Bayer, Cancer Trials Ireland, Canadian Cancer Trials Group, Memorial Sloan Kettering Cancer Center, Prostate Cancer Clinical Trials Consortium
Conditions Prostate Cancer
Enrollment 1,100 participants
Start Date 2020-03-31
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-06