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.
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.
Study Type
OBSERVATIONAL
Enrollment
999
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
Demographics
Patient demographics
Time frame: Up to 5 years
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.
Time frame: Up to 5 years
Health-Related Quality-of-Life Indicators
Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)
Time frame: Up to 5 years
Clinical Characteristics
Clinical characteristics of patients
Time frame: Up to 5 years
Clinical Course and Disease Progression
Changes in disease stage and clinical treatment
Time frame: Up to 5 years
Mortality
Any deaths that occur during the study
Time frame: Up to 5 years
Co-Morbidities
Changes in co-morbidities (presence and/or severity) as assessed by patient's physician
Time frame: Up to 5 years
Treatment Adherence
Describe patient adherence and persistence including reasons for change with ORGOVYX treatment
Time frame: Up to 5 years
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