Recruiting
PHASE1
INTERVENTIONAL
NCT06631521
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Darolutamide
Type:
DRUG
Description:
600 mg (two 300 mg tablets) taken orally twice daily.
Name:
Relugolix
Type:
DRUG
Description:
A loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily.
Name:
Radical Prostatectomy
Type:
PROCEDURE
Description:
Performed at least 48 hours and within 2 weeks after the completion of neoadjuvant therapy.
Primary Outcomes
Measure:
Percentage of patients completing therapy without severe adverse events.
TimeFrame:
From enrollment, up to 8 weeks after radical prostatectomy.
Description:
Measure:
Number of patients experiencing treatment-related adverse events using CTCAE version 5.0.
TimeFrame:
From enrollment, up to 8 weeks following radical prostatectomy (RP)
Description:
Trial Information
NCT ID
NCT06631521
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
AdventHealth
Last Updated
December 15, 2025