DescriPtive Analysis of Real-world Clinical Outcomes of Second Line (2L) Novel Anti-HormonE Therapy (NAH) or RadIum-223 (Xofigo) in Patients With Metastatic Castration Resistance Prostate Cancer (mCRPC) After First Line (1L) NAH Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy
研究概览
简要总结
In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy (NAH) or Radium-223 (Xofigo) after a prior NAH therapy (first line treatment). Additionally the researchers are also interested in the occurrence of bone fractures and other skeletal events. Basis for this study will be the US based Flatiron database which provides access to clinical data for cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with documented mCRPC receiving 1L NAHs.
- •Initiation of Ra-223 after 1L NAH therapy, or
- •Initiation of sequential NAH therapy after 1L NAH therapy
- •Exclusion criteria:
- •Patients involved in clinical trials
- •Patients who received combined therapies in 1L or 2L
排除标准
- 未提供
研究组 & 干预措施
Cohort_2LX
Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as first liine (1L) after diagnosis of mCRPC who then received Ra-223 monotherapy as second line (2L) treatment
干预措施: Radium-223 (Xofigo, BAY88-8223) (Drug)
Cohort_2LX
Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as first liine (1L) after diagnosis of mCRPC who then received Ra-223 monotherapy as second line (2L) treatment
干预措施: Abiraterone (Drug)
Cohort_2LX
Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as first liine (1L) after diagnosis of mCRPC who then received Ra-223 monotherapy as second line (2L) treatment
干预措施: Enzalutamide (Drug)
Cohort_2LH
Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as 1L after diagnosis of mCRPC who then received another NAH monotherapy (i.e., Abiraterone to Enzalutamide or Enzalutamide to Abiraterone) as 2L treatment. None of the patients had ever received Radium-223 dichloride
干预措施: Abiraterone (Drug)
Cohort_2LH
Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as 1L after diagnosis of mCRPC who then received another NAH monotherapy (i.e., Abiraterone to Enzalutamide or Enzalutamide to Abiraterone) as 2L treatment. None of the patients had ever received Radium-223 dichloride
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy
时间窗: Retrospective analysis from 2013-01-01 to 2018-12-30
Overall survival (OS) from initiation of 2L therapy of sequential NAH in patients with mCRPC after 1L NAH therapy
时间窗: Retrospective analysis from 2013-01-01 to 2018-12-30
次要结局
- Descriptive analysis of patient demography at baseline(Retrospective analysis from 2013-01-01 to 2018-12-30)
- Descriptive analysis of clinical characteristics of patients at baseline(Retrospective analysis from 2013-01-01 to 2018-12-30)
- Descriptive analysis of laboratory values at baseline(Retrospective analysis from 2013-01-01 to 2018-12-30)
- Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L(Retrospective analysis from 2013-01-01 to 2018-12-30)
- Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L(Retrospective analysis from 2013-01-01 to 2018-12-30)
- Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L(Retrospective analysis from 2013-01-01 to 2018-12-30)
- Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L(Retrospective analysis from 2013-01-01 to 2018-12-30)
- Period of time from initiation of 2L to first SSE(Retrospective analysis from 2013-01-01 to 2018-12-30)