RecruitingPhase 1NCT06631521

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


Sponsor

AdventHealth

Enrollment

30 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two hormone-blocking drugs — darolutamide and relugolix — given before surgery (radical prostatectomy) in men with high-risk prostate cancer, to see if shrinking the tumor before removal improves outcomes. **You may be eligible if...** - You are a male 18 or older - You have confirmed high-risk prostate cancer - You are a candidate for surgical removal of the prostate (radical prostatectomy) - Your cancer is at clinical stage T2-T4 and has not spread to distant sites **You may NOT be eligible if...** - You have previously received darolutamide, relugolix, or similar hormone-blocking drugs - You had a heart attack, stroke, or serious heart failure in the past 6 months - You have a known allergy to darolutamide or relugolix - You are taking certain medications (strong CYP3A4 inhibitors/inducers) that cannot be stopped Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDarolutamide

600 mg (two 300 mg tablets) taken orally twice daily.

DRUGRelugolix

A loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily.

PROCEDURERadical Prostatectomy

Performed at least 48 hours and within 2 weeks after the completion of neoadjuvant therapy.


Locations(1)

AdventHealth Orlando

Orlando, Florida, United States

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NCT06631521


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