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Prostate cancer drug ORGOVYX under Real-World scrutiny

NCT ID NCT05467176

Disease control Sponsor: Sumitomo Pharma America, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study follows nearly 1,000 prostate cancer patients taking ORGOVYX (relugolix) to see how the drug works in everyday medical practice. Researchers will track side effects, quality of life, and disease progression. The goal is to understand the drug's real-world safety and effectiveness beyond clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Relugolix (ORGOVYX)
What this could lead to
If successful, this study could provide real-world evidence on how well ORGOVYX controls prostate cancer and its side effects in everyday practice.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient differences and routine care variations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

999 people

The number who actually took part.

Started

Oct 2022

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Advanced Urology Associates

    New Lenox, Illinois, 60451, United States

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114, United States

  • Arizona Urology Specialists, PLLC

    Tucson, Arizona, 85704, United States

  • Arkansas Urology Research Center

    Little Rock, Arkansas, 72211, United States

  • Ascend Pharma Holdings

    Houston, Texas, 77079, United States

  • Aspirus

    Wausau, Wisconsin, 54401, United States

  • Associated Medical Professionals of NY, PLLC

    Syracuse, New York, 95054, United States

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415, United States

  • Associated Urologist of North Carolina

    Raleigh, North Carolina, 27612, United States

  • AtlanticCare Cancer Institute

    Egg Harbor, New Jersey, 08234, United States

  • Banner MD Anderson Cancer Center

    Greeley, Colorado, 80631, United States

  • Baptists Health Lexington

    Lexington, Kentucky, 40503, United States

  • Bay Pines VA Healthcare System

    Bay Pines, Florida, 33744, United States

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina, 29572, United States

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230, United States

  • Chesapeake Urology Associates

    Baltimore, Maryland, 21204, United States

  • City of Hope

    Duarte, California, 91010, United States

  • Clinical Inquest Center Ltd

    Beavercreek, Ohio, 45431, United States

  • Colorado Urology

    Lakewood, Colorado, 80228, United States

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010, United States

  • Crystal Run Healthcare

    Middletown, New York, 10941, United States

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina, 28210, United States

  • Dignity Health

    Phoenix, Arizona, 85013, United States

  • Duly Health and Care

    Lisle, Illinois, 60532, United States

  • Durham VA Healthcare

    Durham, North Carolina, 27705, United States

  • Emory University

    Atlanta, Georgia, 30342, United States

  • Florida Urology Partners, LLP

    Tampa, Florida, 33607, United States

  • GU, Inc.

    Latrobe, Pennsylvania, 15650, United States

  • Genesis Care USA

    Naples, Florida, 34119, United States

  • Genesis Research LLC

    San Diego, California, 92123, United States

  • GenesisCare USA

    Troy, Michigan, 48098, United States

  • GenesisCare USA

    Greenville, North Carolina, 27834, United States

  • Georgia Urology

    Decatur, Georgia, 30033, United States

  • Golden State Urology

    Stockton, California, 95219, United States

  • Greater Regional Health

    Creston, Iowa, 50801, United States

  • Hmu, Crc Llc

    Houston, Texas, 77027, United States

  • John Hopkins

    Baltimore, Maryland, 20777, United States

  • Keystone Urology Specialist

    Lancaster, Pennsylvania, 17604, United States

  • Lowcountry Urology Clinics

    North Charleston, South Carolina, 29406, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • Manatee Medical Research Institute, LLC

    Bradenton, Florida, 34205, United States

  • Maryland Oncology Hematology

    Columbia, Maryland, 21044, United States

  • MedAtlantic

    Richmond, Virginia, 23235, United States

  • Medstar Georgetown University Hospital

    Columbia, Maryland, 21044, United States

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • MemorialCare, Long Beach Memorial Medical Center

    Washington D.C., District of Columbia, 20037, United States

  • Michigan Institute of Urology

    Troy, Michigan, 48084, United States

  • Minnesota Urology

    Woodbury, Minnesota, 55125, United States

  • Mohawk Valley Health Services

    Utica, New York, 13502, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NEO Urology Associates, Inc.

    Boardman, Ohio, 44512, United States

  • New Horizon Medical Group, LLC

    Houston, Texas, 77042, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Optum Medical Care, P. C.

    Mount Kisco, New York, 10549, United States

  • Oregon Urology Institute

    Springfield, Oregon, 97477, United States

  • PRiSMS Group LLC

    Arlington Heights, Illinois, 60005, United States

  • Potomac Urology Center, PC

    Alexandria, Virginia, 22311, United States

  • Premier Clinical Research LLC dba STAT Research

    Springboro, Ohio, 45440, United States

  • Regional Cancer Care Associates

    Teaneck, New Jersey, 07666, United States

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045, United States

  • SG Research LLC

    Miami, Florida, 33145, United States

  • SUNY Upstate Medical Institution

    Syracuse, New York, 13210, United States

  • Southern Urology

    Lafayette, Louisiana, 70508, United States

  • Specialty Clinical Research of St. Louis

    St Louis, Missouri, 63141, United States

  • Spokane Urology, P.S.

    Spokane, Washington, 99202, United States

  • Spokenword Clinical Trials

    Easton, Pennsylvania, 18045, United States

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

    Berkeley Heights, New Jersey, 907922, United States

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138, United States

  • The Stamford Hospital

    Stamford, Connecticut, 06902, United States

  • The University of Toledo

    Toledo, Ohio, 43606, United States

  • The Urology Center of Colorado

    Denver, Colorado, 80211, United States

  • The Urology Place

    San Antonio, Texas, 78240, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • Tri Valley Urology

    Murrieta, California, 92562, United States

  • UCSD

    La Jolla, California, 92097, United States

  • USC Norris Cancer Center

    Los Angeles, California, 90033, United States

  • United Medical Group

    Miami, Florida, 33135, United States

  • University Hospitals

    Cleveland, Ohio, 44106, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • UroPartners Research

    Glenview, Illinois, 60026, United States

  • Urologic Specialists of Northwest Indiana

    Merrillville, Indiana, 46410, United States

  • Urologic Surgeons of Washington

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

  • Urology Associates

    Lone Tree, Colorado, 80124, United States

  • Urology Associates of Central California

    Fresno, California, 93720, United States

  • Urology Associates of Mobile

    Mobile, Alabama, 36607, United States

  • Urology Austin

    Austin, Texas, 78759, United States

  • Urology Centers of Alabama

    Homewood, Alabama, 35209, United States

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

    San Antonio, Texas, 78229, United States

  • Urology of Indiana

    Carmel, Indiana, 46032, United States

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia, 23462, United States

  • VA Greater Los Angeles Medical Center

    Los Angeles, California, 90073, United States

  • Wichita Urology Group, P.A.

    Wichita, Kansas, 67226, United States

  • Wisconsin Institute of Urology

    Neenah, Wisconsin, 54956, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.