Clinical Trial

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Recruiting Phase 1
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Record status
This record was last updated February 5, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-10-07; most recent amendment 2026-02-03.
Status change: Not Yet Recruiting → Recruiting 2024-10-29
Trial Details
NCT Number NCT06631521
Lead Sponsor AdventHealth
Collaborators: Bayer, Sumitomo Pharma Switzerland
Conditions Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
Enrollment 30 participants
Start Date 2024-10-22
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-05