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Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

NCT06631521 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Sumitomo Pharma Switzerland

    collaborator UNKNOWN

  • AdventHealth

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631521 on ClinicalTrials.gov