A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 999
- 试验地点
- 180
- 主要终点
- Demographics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Participants with Prostate Cancer
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.
干预措施: Relugolix (Drug)
结局指标
主要结局
Demographics
时间窗: Up to 5 years
Patient demographics
Health-Related Quality-of-Life Indicators
时间窗: Up to 5 years
Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)
Selective Safety Data
时间窗: 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
时间窗: Up to 5 years
Clinical characteristics of patients
次要结局
- Clinical Course and Disease Progression(Up to 5 years)
- Mortality(Up to 5 years)
- Co-Morbidities(Up to 5 years)
- Treatment Adherence(Up to 5 years)