Novel Hormonal Therapies (NHTs) for the Treatment of Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Medicare Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 3,017
- 试验地点
- 1
- 主要终点
- Duration of NHT Treatment
研究概览
简要总结
The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide.
Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.
This is a real-world study, not a clinical trial. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use insurance claim information from Medicare claims data.
The study will include patients' information from the database for men who:
- Were identified to have mCSPC.
- Started treatment with novel hormonal therapy (index date) for mCSPC.
- Were 65 years of age or older one year before index date.
Men in this study will be taking novel hormonal therapy for treatment of their mCSPC. We will describe how long men take novel hormonal therapy. This study will use patient information from insurance claims. It will take information one year before start of novel hormonal treatment until the end of insurance period or until information is available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male with ≥ 1 diagnosis claim for prostate cancer
- •Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
- •Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date.
- •Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date
- •≥65 years old 12 months prior to the index date
- •Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death)
排除标准
- •Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance
- •Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration prior to the index date
- •Had a prior history of other cancers
研究组 & 干预措施
Novel hormonal therapy cohort
Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC
干预措施: Novel hormonal therapy (Drug)
结局指标
主要结局
Duration of NHT Treatment
时间窗: 2 years (retrospective data observation duration)
Treatment duration was defined as the time from the initial claim date of NHT (abiraterone, apalutamide, or enzalutamide) until the end of observation for any of the following reasons: (i) end of data availability (December 31, 2022), (ii) participant's date of death, (iii) day before a treatment switch, (iv) day of treatment discontinuation (a 90-day gap in days supply was considered as discontinuation). Retrospective retrieved data collected was evaluated for approximately 1.2 years of this study. Kaplan-Meier method was used for estimation.
次要结局
未报告次要终点