A Real-World Comparison of Clinical Outcomes in Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Initiated Enzalutamide vs. Abiraterone Acetate (Abiraterone) in Flatiron Electronic Health Record (EHR) Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,731
- 试验地点
- 1
- 主要终点
- Overall Survival (OS): Adjusted Using Inverse Probability Treatment Weighting (IPTW)
研究概览
简要总结
The purpose of this real-world study is to learn about the effects of 2 study medicines called enzalutamide and abiraterone used to treat metastatic castration-resistant prostate cancer (mCRPC).
Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Most prostate cancers need male sex hormones, such as testosterone, to grow. Prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels is known as "castration-resistant". Metastatic cancer is a cancer that has spread to other parts of the body.
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 information from the Flatiron Electronic Health Record (EHR) database.
The study will include patients' information from the database for men who:
- Were confirmed by medical tests to have mCRPC
- Started first-line treatment with enzalutamide or abiraterone (index date) for mCRPC
- Had not received chemotherapy treatment before index date
- Were 18 years of age or older on index date
Men who are part of this study will receive enzalutamide or abiraterone as part of their usual treatment for mCRPC.
We will compare the following between men receiving enzalutamide and men receiving abiraterone:
- time from treatment start until death,
- treatment duration, and
- time to next treatment. This study will use patient information from the database until the end of information that 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male with metastatic prostate cancer diagnosis and abstracted castration-resistant prostate cancer diagnosis
- •Initiated enzalutamide or abiraterone within 14 days prior to or after the metastatic castration-resistant prostate cancer diagnosis. The initiation date of enzalutamide or abiraterone will be defined as the index date.
- •At least 18 years old at the index date
排除标准
- •Received chemotherapy, novel hormonal therapy, radium-223, olaparib/rucaparib, or immunotherapy prior to the index date
- •Had a prior history of other cancers
研究组 & 干预措施
Enzalutamide cohort
Patients with mCRPC initiating enzalutamide
干预措施: Enzalutamide (Drug)
Abiraterone cohort
Patients with mCRPC initiating abiraterone acetate
干预措施: Abiraterone acetate (Drug)
结局指标
主要结局
Overall Survival (OS): Adjusted Using Inverse Probability Treatment Weighting (IPTW)
时间窗: From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months
OS was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die during this period were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Kaplan-Meier (weighted) method was used for analysis.
次要结局
- OS Without Subsequent Therapy: Adjusted Using IPTW(From index date to date of death or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months)
- Time to Treatment Discontinuation (TTD): Adjusted Using IPTW(From index date to date of treatment discontinuation or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months)
- Time to Subsequent Therapy (TTST): Adjusted Using IPTW(From index date to date of start of next LOT or censoring date, whichever occurred first (approximately 104.7 months); retrospective data retrieved and evaluated during approximately 18.7 months)