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

Completed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05467176

Run by

Sumitomo Pharma America, Inc.

People needed

999

Starts

2022-10-04

Expected to finish

2026-06-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• City of Hope — Duarte, California, United States
• Urology Associates of Central California — Fresno, California, United States
• UCSD — La Jolla, California, United States
• USC Norris Cancer Center — Los Angeles, California, United States
• Tower Urology — Los Angeles, California, United States
• VA Greater Los Angeles Medical Center — Los Angeles, California, United States
• Tri Valley Urology — Murrieta, California, United States
• Genesis Research LLC — San Diego, California, United States
• Golden State Urology — Stockton, California, United States
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Banner MD Anderson Cancer Center — Greeley, Colorado, United States
• Colorado Urology — Lakewood, 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
• MemorialCare, Long Beach Memorial Medical Center — Washington D.C., District of Columbia, United States
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States
• Manatee Medical Research Institute, LLC — Bradenton, Florida, United States
• Advanced Urology Institute — Daytona Beach, Florida, United States
• Urology Centers of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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