A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX
- Registration Number
- NCT05467176
- Lead Sponsor
- Sumitomo Pharma Switzerland GmbH
- Brief 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 cessation of ORGOVYX.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 999
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Prostate Cancer Relugolix 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.
- Primary Outcome Measures
Name Time Method Demographics Up to 5 years Patient demographics
Health-Related Quality-of-Life Indicators Up to 5 years Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)
Selective Safety Data 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.
Clinical Characteristics Up to 5 years Clinical characteristics of patients
- Secondary Outcome Measures
Name Time Method Mortality Up to 5 years Any deaths that occur during the study
Clinical Course and Disease Progression Up to 5 years Changes in disease stage and clinical treatment
Co-Morbidities Up to 5 years Changes in co-morbidities (presence and/or severity) as assessed by patient's physician
Treatment Adherence Up to 5 years Describe patient adherence and persistence including reasons for change with ORGOVYX treatment
Trial Locations
- Locations (95)
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
MD Anderson
🇺🇸Houston, Texas, United States
Ascend Pharma Holdings
🇺🇸Houston, Texas, United States
Urology San Antonio, P.A. dba USA Clinical Trials
🇺🇸San Antonio, Texas, United States
City of Hope
🇺🇸Duarte, California, United States
UCSD
🇺🇸La Jolla, California, United States
USC Norris Cancer Center
🇺🇸Los Angeles, California, United States
VA Greater Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Golden State Urology
🇺🇸Stockton, California, United States
Banner MD Anderson Cancer Center
🇺🇸Greeley, Colorado, United States
Colorado Urology
🇺🇸Lakewood, Colorado, United States
MemorialCare, Long Beach Memorial Medical Center
🇺🇸Washington, District of Columbia, United States
Bay Pines VA Healthcare System
🇺🇸Bay Pines, Florida, United States
United Medical Group
🇺🇸Miami, Florida, United States
Genesis Care USA
🇺🇸Naples, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Georgia Urology
🇺🇸Decatur, Georgia, United States
Duly Health and Care
🇺🇸Lisle, Illinois, United States
Greater Regional Health
🇺🇸Creston, Iowa, United States
Baptists Health Lexington
🇺🇸Lexington, Kentucky, United States
John Hopkins
🇺🇸Baltimore, Maryland, United States
Maryland Oncology Hematology
🇺🇸Columbia, Maryland, United States
Medstar Georgetown University Hospital
🇺🇸Columbia, Maryland, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
GenesisCare USA
🇺🇸Greenville, North Carolina, United States
Summit Medical Group, P.A. | New Jersey Urology
🇺🇸Berkeley Heights, New Jersey, United States
Optum Medical Care, P. C.
🇺🇸Mount Kisco, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
SUNY Upstate Medical Institution
🇺🇸Syracuse, New York, United States
Mohawk Valley Health Services
🇺🇸Utica, New York, United States
Durham VA Healthcare
🇺🇸Durham, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
Spokenword Clinical Trials
🇺🇸Easton, Pennsylvania, United States
Aspirus
🇺🇸Wausau, Wisconsin, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Urology Associates of Mobile
🇺🇸Mobile, Alabama, United States
Dignity Health
🇺🇸Phoenix, Arizona, United States
Arizona Urology Specialists, PLLC
🇺🇸Tucson, Arizona, United States
Arkansas Urology Research Center
🇺🇸Little Rock, Arkansas, United States
Urology Associates of Central California
🇺🇸Fresno, California, United States
Tower Urology
🇺🇸Los Angeles, California, United States
Tri Valley Urology
🇺🇸Murrieta, California, United States
Genesis Research LLC
🇺🇸San Diego, California, United States
Rocky Mountain Regional VA Medical Center
🇺🇸Aurora, Colorado, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Urology Associates
🇺🇸Lone Tree, Colorado, United States
The Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Urologic Surgeons of Washington
🇺🇸Washington, D.C., District of Columbia, United States
Manatee Medical Research Institute, LLC
🇺🇸Bradenton, Florida, United States
Advanced Urology Institute
🇺🇸Daytona Beach, Florida, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
SG Research LLC
🇺🇸Miami, Florida, United States
Florida Urology Partners, LLP
🇺🇸Tampa, Florida, United States
PRiSMS Group LLC
🇺🇸Arlington Heights, Illinois, United States
Associated Urological Specialists
🇺🇸Chicago Ridge, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
UroPartners Research
🇺🇸Glenview, Illinois, United States
Comprehensive Urologic Care
🇺🇸Lake Barrington, Illinois, United States
Advanced Urology Associates
🇺🇸New Lenox, Illinois, United States
Urology of Indiana
🇺🇸Carmel, Indiana, United States
Urologic Specialists of Northwest Indiana
🇺🇸Merrillville, Indiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Wichita Urology Group, P.A.
🇺🇸Wichita, Kansas, United States
Southern Urology
🇺🇸Lafayette, Louisiana, United States
Chesapeake Urology Associates
🇺🇸Baltimore, Maryland, United States
Minnesota Urology
🇺🇸Woodbury, Minnesota, United States
Specialty Clinical Research of St. Louis
🇺🇸Saint Louis, Missouri, United States
AtlanticCare Cancer Institute
🇺🇸Egg Harbor Township, New Jersey, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
Regional Cancer Care Associates
🇺🇸Teaneck, New Jersey, United States
Crystal Run Healthcare
🇺🇸Middletown, New York, United States
Associated Medical Professionals of NY, PLLC
🇺🇸Syracuse, New York, United States
DJL Clinical Research, PLLC
🇺🇸Charlotte, North Carolina, United States
Associated Urologist of North Carolina
🇺🇸Raleigh, North Carolina, United States
Clinical Inquest Center Ltd
🇺🇸Beavercreek, Ohio, United States
NEO Urology Associates, Inc.
🇺🇸Boardman, Ohio, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
Central Ohio Urology Group
🇺🇸Gahanna, Ohio, United States
Premier Clinical Research LLC dba STAT Research
🇺🇸Springboro, Ohio, United States
The University of Toledo
🇺🇸Toledo, Ohio, United States
Keystone Urology Specialist
🇺🇸Lancaster, Pennsylvania, United States
GU, Inc.
🇺🇸Latrobe, Pennsylvania, United States
Carolina Urologic Research Center, LLC
🇺🇸Myrtle Beach, South Carolina, United States
Lowcountry Urology Clinics
🇺🇸North Charleston, South Carolina, United States
The Conrad Pearson Clinic
🇺🇸Germantown, Tennessee, United States
Urology Austin
🇺🇸Austin, Texas, United States
Hmu, Crc Llc
🇺🇸Houston, Texas, United States
New Horizon Medical Group, LLC
🇺🇸Houston, Texas, United States
The Urology Place
🇺🇸San Antonio, Texas, United States
Potomac Urology Center, PC
🇺🇸Alexandria, Virginia, United States
MedAtlantic
🇺🇸Richmond, Virginia, United States
Urology of Virginia, PLLC
🇺🇸Virginia Beach, Virginia, United States
Spokane Urology, P.S.
🇺🇸Spokane, Washington, United States
Wisconsin Institute of Urology
🇺🇸Neenah, Wisconsin, United States