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

July 10, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sumitomo Pharma America, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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