Viewing Study NCT05765500



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Last Modification Date: 2024-10-26 @ 2:53 PM
Study NCT ID: NCT05765500
Status: RECRUITING
Last Update Posted: 2024-02-14
First Post: 2023-03-01

Brief Title: RecoverPC Relugolix vs GnRH Agonist in Quality of Life
Sponsor: Dana-Farber Cancer Institute
Organization: Dana-Farber Cancer Institute

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: 2024-02
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
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 US 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: None
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?: None