Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 22, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Prostate CAProstate Cancer (Adenocarcinoma)Prostate Cancer Surgery
Interventions
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.

Trial Locations (1)

32803

RECRUITING

AdventHealth Orlando, Orlando

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Sumitomo Pharma Switzerland

UNKNOWN

lead

AdventHealth

OTHER