A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX

Last updated: August 13, 2025
Sponsor: Sumitomo Pharma America, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Cancer, Early, Recurrent

Prostate Disorders

Treatment

Relugolix

Clinical Study ID

NCT05467176
MVT-601-058
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are diagnosed with prostate cancer and initiating treatment withORGOVYX at the time of enrollment or within 1 month prior to enrollment and whoremain 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)

Exclusion

Exclusion Criteria:

  • Patients with a history of surgical castration

  • Patients with a medical or psychiatric condition that precludes participation in theopinion of the treating physician

  • Patients whose original treatment plan is intended to be less than a total of 4months of ORGOVYX

Study Design

Total Participants: 999
Treatment Group(s): 1
Primary Treatment: Relugolix
Phase:
Study Start date:
October 04, 2022
Estimated Completion Date:
May 31, 2028

Study Description

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.

Connect with a study center

  • Urology Centers of Alabama

    Homewood, Alabama 35209
    United States

    Site Not Available

  • Urology Associates of Mobile

    Mobile, Alabama 36607
    United States

    Site Not Available

  • Dignity Health

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Arizona Urology Specialists, PLLC

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Arkansas Urology Research Center

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Urology Associates of Central California

    Fresno, California 93720
    United States

    Site Not Available

  • UCSD

    La Jolla, California 92097
    United States

    Site Not Available

  • Tower Urology

    Los Angeles, California 90048
    United States

    Site Not Available

  • USC Norris Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • VA Greater Los Angeles Medical Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • Tri Valley Urology

    Murrieta, California 92562
    United States

    Site Not Available

  • Genesis Research LLC

    San Diego, California 92123
    United States

    Site Not Available

  • Golden State Urology

    Stockton, California 95219
    United States

    Site Not Available

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • The Urology Center of Colorado

    Denver, Colorado 80211
    United States

    Site Not Available

  • Banner MD Anderson Cancer Center

    Greeley, Colorado 80631
    United States

    Site Not Available

  • Colorado Urology

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Urology Associates

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • The Stamford Hospital

    Stamford, Connecticut 06902
    United States

    Site Not Available

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MemorialCare, Long Beach Memorial Medical Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Urologic Surgeons of Washington

    Washington, District of Columbia 20036
    United States

    Active - Recruiting

  • Urologic Surgeons of Washington

    Washington, D.C., District of Columbia 20036
    United States

    Site Not Available

  • Bay Pines VA Healthcare System

    Bay Pines, Florida 33744
    United States

    Site Not Available

  • Manatee Medical Research Institute, LLC

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Advanced Urology Institute

    Daytona Beach, Florida 32114
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Site Not Available

  • SG Research LLC

    Miami, Florida 33145
    United States

    Site Not Available

  • United Medical Group

    Miami, Florida 33135
    United States

    Site Not Available

  • Genesis Care USA

    Naples, Florida 34119
    United States

    Site Not Available

  • Florida Urology Partners, LLP

    Tampa, Florida 33607
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Georgia Urology

    Decatur, Georgia 30033
    United States

    Site Not Available

  • PRiSMS Group LLC

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Associated Urological Specialists

    Chicago Ridge, Illinois 60415
    United States

    Site Not Available

  • Northwestern University

    Evanston, Illinois 60208
    United States

    Site Not Available

  • UroPartners Research

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Comprehensive Urologic Care

    Lake Barrington, Illinois 60010
    United States

    Site Not Available

  • Duly Health and Care

    Lisle, Illinois 60532
    United States

    Site Not Available

  • Advanced Urology Associates

    New Lenox, Illinois 60451
    United States

    Site Not Available

  • Urology of Indiana

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Urologic Specialists of Northwest Indiana

    Merrillville, Indiana 46410
    United States

    Site Not Available

  • Greater Regional Health

    Creston, Iowa 50801
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Wichita Urology Group, P.A.

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Baptists Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Southern Urology

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Chesapeake Urology Associates

    Baltimore, Maryland 21204
    United States

    Site Not Available

  • John Hopkins

    Baltimore, Maryland 20777
    United States

    Site Not Available

  • Maryland Oncology Hematology

    Columbia, Maryland 21044
    United States

    Site Not Available

  • Medstar Georgetown University Hospital

    Columbia, Maryland 21044
    United States

    Site Not Available

  • GenesisCare USA

    Troy, Michigan 48098
    United States

    Site Not Available

  • Michigan Institute of Urology

    Troy, Michigan 48084
    United States

    Site Not Available

  • Minnesota Urology

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • Specialty Clinical Research of St. Louis

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Summit Health | New Jersey Urology

    Berkeley Heights, New Jersey 907922
    United States

    Active - Recruiting

  • Summit Medical Group, P.A. | New Jersey Urology

    Berkeley Heights, New Jersey 907922
    United States

    Site Not Available

  • AtlanticCare Cancer Institute

    Egg Harbor Township, New Jersey 08234
    United States

    Site Not Available

  • The Valley Hospital

    Paramus, New Jersey 07652
    United States

    Site Not Available

  • Regional Cancer Care Associates

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Crystal Run Healthcare

    Middletown, New York 10941
    United States

    Site Not Available

  • Optum Medical Care, P. C.

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Urologic Surgeons of Long Island

    Mount Kisco, New York 10549
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Associated Medical Professionals of NY, PLLC

    Syracuse, New York 95054
    United States

    Site Not Available

  • SUNY Upstate Medical Institution

    Syracuse, New York 13210
    United States

    Site Not Available

  • Mohawk Valley Health Services

    Utica, New York 13502
    United States

    Site Not Available

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Durham VA Healthcare

    Durham, North Carolina 27705
    United States

    Site Not Available

  • GenesisCare USA

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Associated Urologist of North Carolina

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Clinical Inquest Center Ltd

    Beavercreek, Ohio 45431
    United States

    Site Not Available

  • NEO Urology Associates, Inc.

    Boardman, Ohio 44512
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Central Ohio Urology Group

    Gahanna, Ohio 43230
    United States

    Site Not Available

  • Premier Clinical Research LLC dba STAT Research

    Springboro, Ohio 45440
    United States

    Site Not Available

  • The University of Toledo

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Oregon Urology Institute

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Spokenword Clinical Trials

    Easton, Pennsylvania 18045
    United States

    Site Not Available

  • Keystone Urology Specialist

    Lancaster, Pennsylvania 17604
    United States

    Site Not Available

  • GU, Inc.

    Latrobe, Pennsylvania 15650
    United States

    Site Not Available

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Lowcountry Urology Clinics

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • The Conrad Pearson Clinic

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Urology Austin

    Austin, Texas 78759
    United States

    Site Not Available

  • Ascend Pharma Holdings

    Houston, Texas 77079
    United States

    Site Not Available

  • Hmu, Crc Llc

    Houston, Texas 77027
    United States

    Site Not Available

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

  • New Horizon Medical Group, LLC

    Houston, Texas 77042
    United States

    Site Not Available

  • The Urology Place

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Urology San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Urology San Antonio, P.A. dba USA Clinical Trials

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Potomac Urology Center, PC

    Alexandria, Virginia 22311
    United States

    Site Not Available

  • MedAtlantic

    Richmond, Virginia 23235
    United States

    Site Not Available

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia 23462
    United States

    Site Not Available

  • Spokane Urology, P.S.

    Spokane, Washington 99202
    United States

    Site Not Available

  • Wisconsin Institute of Urology

    Neenah, Wisconsin 54956
    United States

    Site Not Available

  • Aspirus

    Wausau, Wisconsin 54401
    United States

    Site Not Available

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