Prostate Cancer Clinical Trial
— OPTYXOfficial title:
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
NCT number | NCT05467176 |
Other study ID # | MVT-601-058 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 4, 2022 |
Est. completion date | May 31, 2028 |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | May 31, 2028 |
Est. primary completion date | May 31, 2028 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Potomac Urology Center, PC | Alexandria | Virginia |
United States | PRiSMS Group LLC | Arlington Heights | Illinois |
United States | Rocky Mountain Regional VA Medical Center | Aurora | Colorado |
United States | Urology Austin | Austin | Texas |
United States | Chesapeake Urology Associates | Baltimore | Maryland |
United States | Clinical Inquest Center Ltd | Beavercreek | Ohio |
United States | Summit Health | New Jersey Urology | Berkeley Heights | New Jersey |
United States | NEO Urology Associates, Inc. | Boardman | Ohio |
United States | Manatee Medical Research Institute, LLC | Bradenton | Florida |
United States | Urology of Indiana | Carmel | Indiana |
United States | DJL Clinical Research, PLLC | Charlotte | North Carolina |
United States | Associated Urological Specialists | Chicago Ridge | Illinois |
United States | University Hospitals | Cleveland | Ohio |
United States | Advanced Urology Institute | Daytona Beach | Florida |
United States | The Urology Center of Colorado | Denver | Colorado |
United States | AtlanticCare Cancer Institute | Egg Harbor Township | New Jersey |
United States | Northwestern University | Evanston | Illinois |
United States | Urology Associates of Central California | Fresno | California |
United States | Central Ohio Urology Group | Gahanna | Ohio |
United States | The Conrad Pearson Clinic | Germantown | Tennessee |
United States | UroPartners Research | Glenview | Illinois |
United States | Memorial Healthcare System | Hollywood | Florida |
United States | Urology Centers of Alabama | Homewood | Alabama |
United States | Hmu, Crc Llc | Houston | Texas |
United States | New Horizon Medical Group, LLC | Houston | Texas |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Southern Urology | Lafayette | Louisiana |
United States | Comprehensive Urologic Care | Lake Barrington | Illinois |
United States | Keystone Urology Specialist | Lancaster | Pennsylvania |
United States | GU, Inc. | Latrobe | Pennsylvania |
United States | Arkansas Urology Research Center | Little Rock | Arkansas |
United States | Urology Associates | Lone Tree | Colorado |
United States | Tower Urology | Los Angeles | California |
United States | Urologic Specialists of Northwest Indiana | Merrillville | Indiana |
United States | SG Research LLC | Miami | Florida |
United States | Crystal Run Healthcare | Middletown | New York |
United States | Urology Associates of Mobile | Mobile | Alabama |
United States | Urologic Surgeons of Long Island | Mount Kisco | New York |
United States | Tri Valley Urology | Murrieta | California |
United States | Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina |
United States | Wisconsin Institute of Urology | Neenah | Wisconsin |
United States | Advanced Urology Associates | New Lenox | Illinois |
United States | Lowcountry Urology Clinics | North Charleston | South Carolina |
United States | The Valley Hospital | Paramus | New Jersey |
United States | Dignity Health | Phoenix | Arizona |
United States | Associated Urologist of North Carolina | Raleigh | North Carolina |
United States | MedAtlantic | Richmond | Virginia |
United States | Specialty Clinical Research of St. Louis | Saint Louis | Missouri |
United States | The Urology Place | San Antonio | Texas |
United States | Urology San Antonio | San Antonio | Texas |
United States | Genesis Research LLC | San Diego | California |
United States | Spokane Urology, P.S. | Spokane | Washington |
United States | Premier Clinical Research LLC dba STAT Research | Springboro | Ohio |
United States | The Stamford Hospital | Stamford | Connecticut |
United States | Associated Medical Professionals of NY, PLLC | Syracuse | New York |
United States | Florida Urology Partners, LLP | Tampa | Florida |
United States | Regional Cancer Care Associates | Teaneck | New Jersey |
United States | The University of Toledo | Toledo | Ohio |
United States | Arizona Urology Specialists, PLLC | Tucson | Arizona |
United States | Urology of Virginia, PLLC | Virginia Beach | Virginia |
United States | Urologic Surgeons of Washington | Washington | District of Columbia |
United States | Wichita Urology Group, P.A. | Wichita | Kansas |
United States | Minnesota Urology | Woodbury | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Sumitomo Pharma Switzerland GmbH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demographics | Patient demographics | Up to 5 years | |
Primary | 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. | Up to 5 years | |
Primary | Health-Related Quality-of-Life Indicators | Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs) | Up to 5 years | |
Primary | Clinical Characteristics | Clinical characteristics of patients | Up to 5 years | |
Secondary | Clinical Course and Disease Progression | Changes in disease stage and clinical treatment | Up to 5 years | |
Secondary | Mortality | Any deaths that occur during the study | Up to 5 years | |
Secondary | Co-Morbidities | Changes in co-morbidities (presence and/or severity) as assessed by patient's physician | Up to 5 years | |
Secondary | Treatment Adherence | Describe patient adherence and persistence including reasons for change with ORGOVYX treatment | Up to 5 years |
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