Prostate Cancer
Conditions
Keywords
relugolix, ORGOVYX, prostate cancer, OPTYX
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.
Interventions
DRUGRelugolix
Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
Sponsors
Sumitomo Pharma America, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demographics | Up to 5 years | Patient demographics |
| 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. |
| 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) |
| Clinical Characteristics | Up to 5 years | Clinical characteristics of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Course and Disease Progression | Up to 5 years | Changes in disease stage and clinical treatment |
| Mortality | Up to 5 years | Any deaths that occur during the study |
| 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 |
Countries
United States
Contacts
STUDY_DIRECTORMedical Monitor
Sumitomo Pharma
Outcome results
None listed