RecruitingPhase 2NCT05765500

RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer


Sponsor

Dana-Farber Cancer Institute

Enrollment

110 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label. The names of the study drugs involved in this study are: * Leuprolide (type of ADT) * Relugolix (type of ADT)


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two hormone-suppression treatments for prostate cancer — an older monthly injection (leuprolide) versus a newer daily pill (relugolix) — to see which is better for quality of life, including heart health and sexual function. **You may be eligible if...** - You have been diagnosed with prostate cancer (confirmed by biopsy) - You are a candidate for 6 months of hormone therapy - You have not had prior hormone therapy (GnRH agonist or antagonist) - Your testosterone level is above 200 ng/mL before starting treatment **You may NOT be eligible if...** - You have already received GnRH agonist or antagonist treatment - You need additional systemic cancer treatments beyond hormone therapy and first-generation anti-androgens 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

DRUGRelugolix

Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.

DRUGLeuprolide

Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.


Locations(3)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber Cancer Institute at Foxborough

Foxborough, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT05765500


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