Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2026-01-14 @ 1:27 AM
Study NCT ID:
NCT05765500
Status:
RECRUITING
Last Update Posted:
2025-08-11
First Post:
2023-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: