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Prostate CancerOPTYXNCT05467176

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

An observational study of Prostate Cancer, run by Sumitomo Pharma America, Inc. at 96 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Relugolix
Type of treatment
Pill or oral medicine
How many people
999 participants
Where
96 sitesUnited States
Study dates
4 Oct 2022to 30 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

96 sites in 1 country.

96 sites in 1 country

United States96 sites

  • Potomac Urology Center, PC

    Alexandria, Virginia, 22311

  • PRiSMS Group LLC

    Arlington Heights, Illinois, 60005

  • Emory University

    Atlanta, Georgia, 30342

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

  • Urology Austin

    Austin, Texas, 78759

  • John Hopkins

    Baltimore, Maryland, 20777

  • Chesapeake Urology Associates

    Baltimore, Maryland, 21204

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744

  • Clinical Inquest Center Ltd

    Beavercreek, Ohio, 45431

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

    Berkeley Heights, New Jersey, 907922

  • NEO Urology Associates, Inc.

    Boardman, Ohio, 44512

  • Manatee Medical Research Institute, LLC

    Bradenton, Florida, 34205

  • Urology of Indiana

    Carmel, Indiana, 46032

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • University Hospitals

    Cleveland, Ohio, 44106

  • Maryland Oncology Hematology

    Columbia, Maryland, 21044

  • Medstar Georgetown University Hospital

    Columbia, Maryland, 21044

  • Greater Regional Health

    Creston, Iowa, 50801

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114

  • Georgia Urology

    Decatur, Georgia, 30033

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • City of Hope

    Duarte, California, 91010

  • Durham VA Healthcare

    Durham, North Carolina, 27705

  • Spokenword Clinical Trials

    Easton, Pennsylvania, 18045

  • AtlanticCare Cancer Institute

    Egg Harbor, New Jersey, 08234

  • Northwestern University

    Evanston, Illinois, 60208

  • Urology Associates of Central California

    Fresno, California, 93720

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138

  • UroPartners Research

    Glenview, Illinois, 60026

  • Banner MD Anderson Cancer Center

    Greeley, Colorado, 80631

  • GenesisCare USA

    Greenville, North Carolina, 27834

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • Hmu, Crc Llc

    Houston, Texas, 77027

  • MD Anderson

    Houston, Texas, 77030

  • New Horizon Medical Group, LLC

    Houston, Texas, 77042

  • Ascend Pharma Holdings

    Houston, Texas, 77079

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • UCSD

    La Jolla, California, 92097

  • Southern Urology

    Lafayette, Louisiana, 70508

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010

  • Colorado Urology

    Lakewood, Colorado, 80228

  • Keystone Urology Specialist

    Lancaster, Pennsylvania, 17604

  • GU, Inc.

    Latrobe, Pennsylvania, 15650

  • Baptists Health Lexington

    Lexington, Kentucky, 40503

  • Duly Health and Care

    Lisle, Illinois, 60532

  • Arkansas Urology Research Center

    Little Rock, Arkansas, 72211

  • Urology Associates

    Lone Tree, Colorado, 80124

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • Tower Urology

    Los Angeles, California, 90048

  • VA Greater Los Angeles Medical Center

    Los Angeles, California, 90073

  • Urologic Specialists of Northwest Indiana

    Merrillville, Indiana, 46410

  • United Medical Group

    Miami, Florida, 33135

  • SG Research LLC

    Miami, Florida, 33145

  • Crystal Run Healthcare

    Middletown, New York, 10941

  • Urology Associates of Mobile

    Mobile, Alabama, 36607

  • Optum Medical Care, P. C.

    Mount Kisco, New York, 10549

  • Tri Valley Urology

    Murrieta, California, 92562

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572

  • Genesis Care USA

    Naples, Florida, 34119

  • Wisconsin Institute of Urology

    Neenah, Wisconsin, 54956

  • Advanced Urology Associates

    New Lenox, Illinois, 60451

  • Mount Sinai Hospital

    New York, New York, 10029

  • Lowcountry Urology Clinics

    North Charleston, South Carolina, 29406

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Dignity Health

    Phoenix, Arizona, 85013

  • Associated Urologist of North Carolina

    Raleigh, North Carolina, 27612

  • MedAtlantic

    Richmond, Virginia, 23235

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

    San Antonio, Texas, 78229

  • The Urology Place

    San Antonio, Texas, 78240

  • Genesis Research LLC

    San Diego, California, 92123

  • Spokane Urology, P.S.

    Spokane, Washington, 99202

  • Premier Clinical Research LLC dba STAT Research

    Springboro, Ohio, 45440

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141

  • The Stamford Hospital

    Stamford, Connecticut, 06902

  • Golden State Urology

    Stockton, California, 95219

  • SUNY Upstate Medical Institution

    Syracuse, New York, 13210

  • Associated Medical Professionals of NY, PLLC

    Syracuse, New York, 95054

  • Florida Urology Partners, LLP

    Tampa, Florida, 33607

  • Regional Cancer Care Associates

    Teaneck, New Jersey, 07666

  • The University of Toledo

    Toledo, Ohio, 43606

  • Michigan Institute of Urology

    Troy, Michigan, 48084

  • GenesisCare USA

    Troy, Michigan, 48098

  • Arizona Urology Specialists, PLLC

    Tucson, Arizona, 85704

  • Mohawk Valley Health Services

    Utica, New York, 13502

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia, 23462

  • Urologic Surgeons of Washington

    Washington D.C., District of Columbia, 20036

  • MemorialCare, Long Beach Memorial Medical Center

    Washington D.C., District of Columbia, 20037

  • Aspirus

    Wausau, Wisconsin, 54401

  • Wichita Urology Group, P.A.

    Wichita, Kansas, 67226

  • Minnesota Urology

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Relugolix
Keywords
relugolix, ORGOVYX, prostate cancer, OPTYX
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelugolixDrug

    Also called TAK-385, MVT-601, RVT-601, T-1331285

    Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1

Study groups in NCT05467176
Study groupRoleWhat they receive
Participants with Prostate CancerPatients 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.
Receives: Drug: Relugolix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographics

    Patient demographics

    Measured: Up to 5 years

  2. 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.

    Measured: Up to 5 years

  3. Health-Related Quality-of-Life Indicators

    Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)

    Measured: Up to 5 years

  4. Clinical Characteristics

    Clinical characteristics of patients

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Clinical Course and Disease Progression

    Changes in disease stage and clinical treatment

    Measured: Up to 5 years

  2. Mortality

    Any deaths that occur during the study

    Measured: Up to 5 years

  3. Co-Morbidities

    Changes in co-morbidities (presence and/or severity) as assessed by patient's physician

    Measured: Up to 5 years

  4. Treatment Adherence

    Describe patient adherence and persistence including reasons for change with ORGOVYX treatment

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study start4 Oct 2022
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
999 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05467176
Sponsor's protocol ID
MVT-601-058
Acronym
OPTYX
Status last verified
Jul 2026
First submitted
15 Jun 2022
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38488039

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Sumitomo Pharma America, Inc. at 96 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographics (time frame: Up to 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05467176, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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