A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
OPTYX
1 other identifier
observational
999
1 country
96
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
October 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
April 8, 2026
April 1, 2026
3.7 years
June 15, 2022
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Demographics
Patient demographics
Up to 5 years
Selective Safety Data
Incidence of treatment-related serious adverse events and any adverse events resulting in discontinuation of ORGOVYX as reported by physician or patient.
Up to 5 years
Health-Related Quality-of-Life Indicators
Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)
Up to 5 years
Clinical Characteristics
Clinical characteristics of patients
Up to 5 years
Secondary Outcomes (4)
Clinical Course and Disease Progression
Up to 5 years
Mortality
Up to 5 years
Co-Morbidities
Up to 5 years
Treatment Adherence
Up to 5 years
Study Arms (1)
Participants with Prostate Cancer
Patients with prostate cancer who are initiating treatment or have initiated treatment with ORGOVYX (per label instructions) within 1 month prior to enrollment and who remain on treatment at the time of enrollment.
Interventions
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
Eligibility Criteria
Patients with prostate cancer who are initiating treatment or have initiated treatment with ORGOVYX within 1 month prior to enrollment and who remain on treatment at the time of enrollment
You may qualify if:
- Patients who are diagnosed with prostate cancer and initiating treatment with ORGOVYX at the time of enrollment or within 1 month prior to enrollment and who remain on treatment at enrollment
- Patients who are willing and able to complete PRO assessments during the study
- Patients who have reviewed and signed the informed consent form (ICF)
You may not qualify if:
- Patients with a history of surgical castration
- Patients with a medical or psychiatric condition that precludes participation in the opinion of the treating physician
- Patients whose original treatment plan is intended to be less than a total of 4 months of ORGOVYX
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Urology Associates of Mobile
Mobile, Alabama, 36607, United States
Dignity Health
Phoenix, Arizona, 85013, United States
Arizona Urology Specialists, PLLC
Tucson, Arizona, 85704, United States
Arkansas Urology Research Center
Little Rock, Arkansas, 72211, United States
City of Hope
Duarte, California, 91010, United States
Urology Associates of Central California
Fresno, California, 93720, United States
UCSD
La Jolla, California, 92097, United States
USC Norris Cancer Center
Los Angeles, California, 90033, United States
Tower Urology
Los Angeles, California, 90048, United States
VA Greater Los Angeles Medical Center
Los Angeles, California, 90073, United States
Tri Valley Urology
Murrieta, California, 92562, United States
Genesis Research LLC
San Diego, California, 92123, United States
Golden State Urology
Stockton, California, 95219, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, 80631, United States
Colorado Urology
Lakewood, Colorado, 80228, United States
Urology Associates
Lone Tree, Colorado, 80124, United States
The Stamford Hospital
Stamford, Connecticut, 06902, United States
Urologic Surgeons of Washington
Washington D.C., District of Columbia, 20036, United States
MemorialCare, Long Beach Memorial Medical Center
Washington D.C., District of Columbia, 20037, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
Manatee Medical Research Institute, LLC
Bradenton, Florida, 34205, United States
Advanced Urology Institute
Daytona Beach, Florida, 32114, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
United Medical Group
Miami, Florida, 33135, United States
SG Research LLC
Miami, Florida, 33145, United States
Genesis Care USA
Naples, Florida, 34119, United States
Florida Urology Partners, LLP
Tampa, Florida, 33607, United States
Emory University
Atlanta, Georgia, 30342, United States
Georgia Urology
Decatur, Georgia, 30033, United States
PRiSMS Group LLC
Arlington Heights, Illinois, 60005, United States
Associated Urological Specialists
Chicago Ridge, Illinois, 60415, United States
Northwestern University
Evanston, Illinois, 60208, United States
UroPartners Research
Glenview, Illinois, 60026, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, 60010, United States
Duly Health and Care
Lisle, Illinois, 60532, United States
Advanced Urology Associates
New Lenox, Illinois, 60451, United States
Urology of Indiana
Carmel, Indiana, 46032, United States
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, 46410, United States
Greater Regional Health
Creston, Iowa, 50801, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Wichita Urology Group, P.A.
Wichita, Kansas, 67226, United States
Baptists Health Lexington
Lexington, Kentucky, 40503, United States
Southern Urology
Lafayette, Louisiana, 70508, United States
John Hopkins
Baltimore, Maryland, 20777, United States
Chesapeake Urology Associates
Baltimore, Maryland, 21204, United States
Maryland Oncology Hematology
Columbia, Maryland, 21044, United States
Medstar Georgetown University Hospital
Columbia, Maryland, 21044, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
GenesisCare USA
Troy, Michigan, 48098, United States
Minnesota Urology
Woodbury, Minnesota, 55125, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141, United States
Summit Medical Group, P.A. | New Jersey Urology
Berkeley Heights, New Jersey, 907922, United States
AtlanticCare Cancer Institute
Egg Harbor, New Jersey, 08234, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
Regional Cancer Care Associates
Teaneck, New Jersey, 07666, United States
Crystal Run Healthcare
Middletown, New York, 10941, United States
Optum Medical Care, P. C.
Mount Kisco, New York, 10549, United States
Mount Sinai Hospital
New York, New York, 10029, United States
SUNY Upstate Medical Institution
Syracuse, New York, 13210, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 95054, United States
Mohawk Valley Health Services
Utica, New York, 13502, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, 28210, United States
Durham VA Healthcare
Durham, North Carolina, 27705, United States
GenesisCare USA
Greenville, North Carolina, 27834, United States
Associated Urologist of North Carolina
Raleigh, North Carolina, 27612, United States
Clinical Inquest Center Ltd
Beavercreek, Ohio, 45431, United States
NEO Urology Associates, Inc.
Boardman, Ohio, 44512, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
University Hospitals
Cleveland, Ohio, 44106, United States
Central Ohio Urology Group
Gahanna, Ohio, 43230, United States
Premier Clinical Research LLC dba STAT Research
Springboro, Ohio, 45440, United States
The University of Toledo
Toledo, Ohio, 43606, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Spokenword Clinical Trials
Easton, Pennsylvania, 18045, United States
Keystone Urology Specialist
Lancaster, Pennsylvania, 17604, United States
GU, Inc.
Latrobe, Pennsylvania, 15650, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, 29406, United States
The Conrad Pearson Clinic
Germantown, Tennessee, 38138, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Urology Austin
Austin, Texas, 78759, United States
Hmu, Crc Llc
Houston, Texas, 77027, United States
MD Anderson
Houston, Texas, 77030, United States
New Horizon Medical Group, LLC
Houston, Texas, 77042, United States
Ascend Pharma Holdings
Houston, Texas, 77079, United States
Urology San Antonio, P.A. dba USA Clinical Trials
San Antonio, Texas, 78229, United States
The Urology Place
San Antonio, Texas, 78240, United States
Potomac Urology Center, PC
Alexandria, Virginia, 22311, United States
MedAtlantic
Richmond, Virginia, 23235, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Spokane Urology, P.S.
Spokane, Washington, 99202, United States
Wisconsin Institute of Urology
Neenah, Wisconsin, 54956, United States
Aspirus
Wausau, Wisconsin, 54401, United States
Related Publications (1)
Spratt DE, Dorff T, McKay RR, Lowentritt BH, Fallick M, Gatoulis SC, Flanders SC, Ross AE. Evaluating relugolix for the treatment of prostate cancer in real-world settings of care: the OPTYX study protocol. Future Oncol. 2024 Apr;20(12):727-738. doi: 10.2217/fon-2023-0748. Epub 2024 Mar 15.
PMID: 38488039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Sumitomo Pharma
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2022
First Posted
July 20, 2022
Study Start
October 4, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 30, 2026
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share