Use of Darolutamide, Enzalutamide and Apalutamide for Non-metastatic Castration-Resistant Prostate Cancer (nmCRPC) - EXTension of the DEAR Real-world Study (NCT05362149)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,375
- 试验地点
- 1
- 主要终点
- Time to ARI treatment discontinuation
研究概览
简要总结
This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide.
The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones.
The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. .
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
- •Men diagnosed with prostate cancer.
- •Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation
- •Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time
- •Age ≥ 18 years at treatment start
- •At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months.
排除标准
- •Evidence of metastatic disease before or 30 days after treatment start
- •Prior history of other primary cancers
研究组 & 干预措施
Enzalutamide
干预措施: Enzalutamide (Drug)
Apalutamide
干预措施: Apalutamide (Drug)
Darolutamide
干预措施: Darolutamide (BAY 1841788) (Drug)
结局指标
主要结局
Time to ARI treatment discontinuation
时间窗: Retrospective analysis from 01-Aug-2019 to 30 Sep 2023
次要结局
- Proportion of patients, who switched to another ARI therapy(Retrospective analysis from 01-Aug-2019 to 30 Sep 2023)
- Frequency of adverse events(Retrospective analysis from 01-Aug-2019 to 30 Sep 2023)
- Dose modification of initial ARI(Retrospective analysis from 01-Aug-2019 to 30 Sep 2023)
- Reasons for ARI treatment discontinuation(Retrospective analysis from 01-Aug-2019 to 30 Sep 2023)
- Time to progression to mCRPC(Retrospective analysis from 01-Aug-2019 to 30 Sep 2023)