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

April 2, 2026 updated by: Sumitomo Pharma America, Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
      • Mobile, Alabama, United States, 36607
        • Urology Associates of Mobile
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Dignity Health
      • Tucson, Arizona, United States, 85704
        • Arizona Urology Specialists, PLLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology Research Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Fresno, California, United States, 93720
        • Urology Associates of Central California
      • La Jolla, California, United States, 92097
        • UCSD
      • Los Angeles, California, United States, 90033
        • USC Norris Cancer Center
      • Los Angeles, California, United States, 90048
        • Tower Urology
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Medical Center
      • Murrieta, California, United States, 92562
        • Tri Valley Urology
      • San Diego, California, United States, 92123
        • Genesis Research LLC
      • Stockton, California, United States, 95219
        • Golden State Urology
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Regional VA Medical Center
      • Denver, Colorado, United States, 80211
        • The Urology Center of Colorado
      • Greeley, Colorado, United States, 80631
        • Banner MD Anderson Cancer Center
      • Lakewood, Colorado, United States, 80228
        • Colorado Urology
      • Lone Tree, Colorado, United States, 80124
        • Urology Associates
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • The Stamford Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20036
        • Urologic Surgeons of Washington
      • Washington D.C., District of Columbia, United States, 20037
        • MemorialCare, Long Beach Memorial Medical Center
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Healthcare System
      • Bradenton, Florida, United States, 34205
        • Manatee Medical Research Institute, LLC
      • Daytona Beach, Florida, United States, 32114
        • Advanced Urology Institute
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System
      • Miami, Florida, United States, 33145
        • SG Research LLC
      • Miami, Florida, United States, 33135
        • United Medical Group
      • Naples, Florida, United States, 34119
        • Genesis Care USA
      • Tampa, Florida, United States, 33607
        • Florida Urology Partners, LLP
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Emory University
      • Decatur, Georgia, United States, 30033
        • Georgia Urology
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • PRiSMS Group LLC
      • Chicago Ridge, Illinois, United States, 60415
        • Associated Urological Specialists
      • Evanston, Illinois, United States, 60208
        • Northwestern University
      • Glenview, Illinois, United States, 60026
        • UroPartners Research
      • Lake Barrington, Illinois, United States, 60010
        • Comprehensive Urologic Care
      • Lisle, Illinois, United States, 60532
        • Duly Health and Care
      • New Lenox, Illinois, United States, 60451
        • Advanced Urology Associates
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Urology of Indiana
      • Merrillville, Indiana, United States, 46410
        • Urologic Specialists of Northwest Indiana
    • Iowa
      • Creston, Iowa, United States, 50801
        • Greater Regional Health
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Wichita, Kansas, United States, 67226
        • Wichita Urology Group, P.A.
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptists Health Lexington
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Southern Urology
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Chesapeake Urology Associates
      • Baltimore, Maryland, United States, 20777
        • John Hopkins
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology
      • Columbia, Maryland, United States, 21044
        • MedStar Georgetown University Hospital
    • Michigan
      • Troy, Michigan, United States, 48084
        • Michigan Institute of Urology
      • Troy, Michigan, United States, 48098
        • GenesisCare USA
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Urology
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Specialty Clinical Research of St. Louis
    • New Jersey
      • Berkeley Heights, New Jersey, United States, 907922
        • Summit Medical Group, P.A. | New Jersey Urology
      • Egg Harbor, New Jersey, United States, 08234
        • AtlanticCare Cancer Institute
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
      • Teaneck, New Jersey, United States, 07666
        • Regional Cancer Care Associates
    • New York
      • Middletown, New York, United States, 10941
        • Crystal Run Healthcare
      • Mount Kisco, New York, United States, 10549
        • Optum Medical Care, P. C.
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical Institution
      • Syracuse, New York, United States, 95054
        • Associated Medical Professionals of NY, PLLC
      • Utica, New York, United States, 13502
        • Mohawk Valley Health Services
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • DJL Clinical Research, PLLC
      • Durham, North Carolina, United States, 27705
        • Durham VA Healthcare
      • Greenville, North Carolina, United States, 27834
        • GenesisCare USA
      • Raleigh, North Carolina, United States, 27612
        • Associated Urologist of North Carolina
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Clinical Inquest Center Ltd
      • Boardman, Ohio, United States, 44512
        • NEO Urology Associates, Inc.
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
      • Gahanna, Ohio, United States, 43230
        • Central Ohio Urology Group
      • Springboro, Ohio, United States, 45440
        • Premier Clinical Research LLC dba STAT Research
      • Toledo, Ohio, United States, 43606
        • The University of Toledo
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Oregon Urology Institute
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Spokenword Clinical Trials
      • Lancaster, Pennsylvania, United States, 17604
        • Keystone Urology Specialist
      • Latrobe, Pennsylvania, United States, 15650
        • GU, Inc.
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center, LLC
      • North Charleston, South Carolina, United States, 29406
        • Lowcountry Urology Clinics
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Conrad Pearson Clinic
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Texas
      • Austin, Texas, United States, 78759
        • Urology Austin
      • Houston, Texas, United States, 77030
        • MD Anderson
      • Houston, Texas, United States, 77027
        • Hmu, Crc Llc
      • Houston, Texas, United States, 77042
        • New Horizon Medical Group, LLC
      • Houston, Texas, United States, 77079
        • Ascend Pharma Holdings
      • San Antonio, Texas, United States, 78240
        • The Urology Place
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio, P.A. dba USA Clinical Trials
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Potomac Urology Center, PC
      • Richmond, Virginia, United States, 23235
        • MedAtlantic
      • Virginia Beach, Virginia, United States, 23462
        • Urology Of Virginia, Pllc
    • Washington
      • Spokane, Washington, United States, 99202
        • Spokane Urology, P.S.
    • Wisconsin
      • Neenah, Wisconsin, United States, 54956
        • Wisconsin Institute of Urology
      • Wausau, Wisconsin, United States, 54401
        • Aspirus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: 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 Names:
  • TAK-385
  • MVT-601
  • RVT-601
  • T-1331285
  • ORGOVYX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Up to 5 years
Patient demographics
Up to 5 years
Selective Safety Data
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)
Up to 5 years
Clinical Characteristics
Time Frame: Up to 5 years
Clinical characteristics of patients
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Course and Disease Progression
Time Frame: Up to 5 years
Changes in disease stage and clinical treatment
Up to 5 years
Mortality
Time Frame: Up to 5 years
Any deaths that occur during the study
Up to 5 years
Co-Morbidities
Time Frame: Up to 5 years
Changes in co-morbidities (presence and/or severity) as assessed by patient's physician
Up to 5 years
Treatment Adherence
Time Frame: Up to 5 years
Describe patient adherence and persistence including reasons for change with ORGOVYX treatment
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma America, Inc.

Investigators

  • Study Director: Medical Monitor, Sumitomo Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MVT-601-058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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