Clinical Trial

Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

Study acronym: DARIUS
Recruiting Phase 2
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Summary
Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-04-21; most recent amendment 2025-10-01.
Status change: Not Yet Recruiting → Recruiting 2023-03-01
Trial Details
NCT Number NCT05346848
Lead Sponsor Institut Bergonié
Collaborators: Bayer
Conditions Prostate Cancer
Enrollment 62 participants
Start Date 2023-02-24
Primary Completion 2026-12 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2025-10-02