NCT05765500

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a phase 2 clinical trial comparing patient-reported Quality of Life (QOL) among men with localized or biochemically recurrent prostate cancer treated with relugolix versus leuprolide depot therapy. Participants will be randomized into one of the study groups leuprolide versus relugolix. Randomization means that a participant is put into a study group by chance. The U.S. Food and Drug Administration (FDA) has approved leuprolide and relugolix as treatment options for prostate cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits, ECGs, and blood tests. Participation in this research study is expected to last 12 months. It is expected about 110 people will take part in this research study. The Prostate Cancer Foundation and Pfizer are supporting this research study by providing funding. Myovant is supporting this study by providing the drug, Relugolix.

Conditions

• Prostate Cancer
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Relugolix	Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.
DRUG	Leuprolide	Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.

Timeline

• Start date: 2024-02-12
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2023-03-13
• Last updated: 2025-08-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study