NCT06631521

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for High Risk Localized and Locally Advanced Prostate Cancer: A Phase I/Ib Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: AdventHealth · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate CA
• Prostate Cancer (Adenocarcinoma)
• Prostate Cancer Surgery

Interventions

Type	Name	Description
DRUG	Darolutamide	600 mg (two 300 mg tablets) taken orally twice daily.
DRUG	Relugolix	A loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily.
PROCEDURE	Radical Prostatectomy	Performed at least 48 hours and within 2 weeks after the completion of neoadjuvant therapy.

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-10-08
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study