A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
- Registration Number
- NCT05467176
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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)
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
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