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This is a multi-center, prospective, observational study of patients being treated with ORGOVYX. The goal of this study is to generate real-world evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.
This prospective observational cohort study will be conducted in patients who are initiating treatment or have initiated treatment with ORGOVYX within the 1 month prior to the time of study enrollment and who remain on treatment at the time of enrollment. The decision to initiate treatment with ORGOVYX should be made prior to study enrollment. The study is designed to better understand the actual experience of patients with prostate cancer treated with ORGOVYX by collecting data on treatment patterns, adherence, and selective safety data. Additionally, a better understanding of the trajectory of patients with prostate cancer following cessation of ORGOVYX therapy will be gained by observing the clinical course of the disease, health outcomes, and health-related quality-of-life (HRQoL) in these patients.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Urology Centers of Alabama
Homewood, Alabama, United States
Urology Associates of Mobile
Mobile, Alabama, United States
Dignity Health
Phoenix, Arizona, United States
Arizona Urology Specialists, PLLC
Tucson, Arizona, United States
Arkansas Urology Research Center
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Urology Associates of Central California
Fresno, California, United States
UCSD
La Jolla, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
Tower Urology
Los Angeles, California, United States
Start Date
October 4, 2022
Primary Completion Date
May 31, 2028
Completion Date
May 31, 2028
Last Updated
August 17, 2025
999
ACTUAL participants
Relugolix
DRUG
Lead Sponsor
Sumitomo Pharma America, Inc.
NCT04550494
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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