A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
NCT ID: NCT05467176
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
999 participants
OBSERVATIONAL
2022-10-04
2028-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
GVAX in Advanced Prostate Cancer Patients Made Lymphopenic
NCT00122005
Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
NCT00138918
The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
NCT06111781
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
NCT05053152
Pembrolizumab and Cryosurgery in Treating Patients With Newly Diagnosed, Oligo-metastatic Prostate Cancer
NCT02489357
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Relugolix
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Relugolix
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who are willing and able to complete PRO assessments during the study
* Patients who have reviewed and signed the informed consent form (ICF)
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Sumitomo Pharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
VA Greater Los Angeles Medical Center
Los Angeles, California, United States
Tri Valley Urology
Murrieta, California, United States
Genesis Research LLC
San Diego, California, United States
Golden State Urology
Stockton, California, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
Banner MD Anderson Cancer Center
Greeley, Colorado, United States
Colorado Urology
Lakewood, Colorado, United States
Urology Associates
Lone Tree, Colorado, United States
The Stamford Hospital
Stamford, Connecticut, United States
Urologic Surgeons of Washington
Washington D.C., District of Columbia, United States
MemorialCare, Long Beach Memorial Medical Center
Washington D.C., District of Columbia, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
Manatee Medical Research Institute, LLC
Bradenton, Florida, United States
Advanced Urology Institute
Daytona Beach, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
United Medical Group
Miami, Florida, United States
SG Research LLC
Miami, Florida, United States
Genesis Care USA
Naples, Florida, United States
Florida Urology Partners, LLP
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Georgia Urology
Decatur, Georgia, United States
PRiSMS Group LLC
Arlington Heights, Illinois, United States
Associated Urological Specialists
Chicago Ridge, Illinois, United States
Northwestern University
Evanston, Illinois, United States
UroPartners Research
Glenview, Illinois, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, United States
Duly Health and Care
Lisle, Illinois, United States
Advanced Urology Associates
New Lenox, Illinois, United States
Urology of Indiana
Carmel, Indiana, United States
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, United States
Greater Regional Health
Creston, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Wichita Urology Group, P.A.
Wichita, Kansas, United States
Baptists Health Lexington
Lexington, Kentucky, United States
Southern Urology
Lafayette, Louisiana, United States
John Hopkins
Baltimore, Maryland, United States
Chesapeake Urology Associates
Baltimore, Maryland, United States
Maryland Oncology Hematology
Columbia, Maryland, United States
Medstar Georgetown University Hospital
Columbia, Maryland, United States
Michigan Institute of Urology
Troy, Michigan, United States
GenesisCare USA
Troy, Michigan, United States
Minnesota Urology
Woodbury, Minnesota, United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, United States
Summit Medical Group, P.A. | New Jersey Urology
Berkeley Heights, New Jersey, United States
AtlanticCare Cancer Institute
Egg Harbor, New Jersey, United States
The Valley Hospital
Paramus, New Jersey, United States
Regional Cancer Care Associates
Teaneck, New Jersey, United States
Crystal Run Healthcare
Middletown, New York, United States
Optum Medical Care, P. C.
Mount Kisco, New York, United States
Mount Sinai Hospital
New York, New York, United States
SUNY Upstate Medical Institution
Syracuse, New York, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, United States
Mohawk Valley Health Services
Utica, New York, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Durham VA Healthcare
Durham, North Carolina, United States
GenesisCare USA
Greenville, North Carolina, United States
Associated Urologist of North Carolina
Raleigh, North Carolina, United States
Clinical Inquest Center Ltd
Beavercreek, Ohio, United States
NEO Urology Associates, Inc.
Boardman, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
Central Ohio Urology Group
Gahanna, Ohio, United States
Premier Clinical Research LLC dba STAT Research
Springboro, Ohio, United States
The University of Toledo
Toledo, Ohio, United States
Oregon Urology Institute
Springfield, Oregon, United States
Spokenword Clinical Trials
Easton, Pennsylvania, United States
Keystone Urology Specialist
Lancaster, Pennsylvania, United States
GU, Inc.
Latrobe, Pennsylvania, United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, United States
Lowcountry Urology Clinics
North Charleston, South Carolina, United States
The Conrad Pearson Clinic
Germantown, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Urology Austin
Austin, Texas, United States
Hmu, Crc Llc
Houston, Texas, United States
MD Anderson
Houston, Texas, United States
New Horizon Medical Group, LLC
Houston, Texas, United States
Ascend Pharma Holdings
Houston, Texas, United States
Urology San Antonio, P.A. dba USA Clinical Trials
San Antonio, Texas, United States
The Urology Place
San Antonio, Texas, United States
Potomac Urology Center, PC
Alexandria, Virginia, United States
MedAtlantic
Richmond, Virginia, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States
Spokane Urology, P.S.
Spokane, Washington, United States
Wisconsin Institute of Urology
Neenah, Wisconsin, United States
Aspirus
Wausau, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MVT-601-058
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.