Novel Hormonal Therapy (NHT) for Treating Patients With Metastatic Castration-Sensitive Prostate Cancer (mCSPC): An Analysis of National Veterans Affairs Health Care Network Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,313
- 试验地点
- 1
- 主要终点
- Duration of Therapy (DOT)
研究概览
简要总结
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines:
- abiraterone,
- apalutamide,
- 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. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer.
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 National Veteran's Affairs (VA) Health Care Network.
The study will include patients' information from the database for men who:
- were identified to have mCSPC.
- started treatment with NHT for mCSPC.
- were 18 years of age or older at start of NHT.
Men in this study will be taking NHT for treatment of their mCSPC. The study will explain:
- how long men take the therapy.
- how long it takes to start next therapy.
This study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT 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
- 18 Years 至 —（Adult, 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
- •Had documented secondary metastasis code on or after the initial prostate cancer diagnosis
- •Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 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
- •≥18 years old on index date
- •Continuous enrollment for at least 365 days before index date
- •Evidence to be castration-sensitive:
- •No prior surgical castration any time prior to the index date or no medical castration with ≥8 weeks of continuous use within -90 to -365 days prior to the index date, OR
- •Diagnosis of hormone sensitive malignancy status within 90 days before the index date
排除标准
- •Evidence of castration-resistance prior to the index date
- •Received other prostate cancer treatment including NHT, non-steroidal anti-androgen (NSAA), chemotherapy, immunotherapy, radium 223, lutetium Lu 177 vipivotide tetraxetan, ketoconazole, or PARP inhibitor prior to the index date
- •Had diagnosis code indicating hormone resistance prior to the index date
- •A rise in prostate-specific antigen from the nadir by ≥2 ng/mL after castration
- •Had a prior history of other cancers (except non-melanoma skin cancer)
- •Participation in a clinical trial during the 30 days before the index date
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 Therapy (DOT)
时间窗: From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months
DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months).
次要结局
- Time to Next Therapy (TTNT)(From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months)