Real World Evaluation of Access-driven Canadian Treatment Sequences in Progressive Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 4,301
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Study to gather information about the optimal placement of Ra-223 in the order of different treatments in terms of the effect on patients and in terms of the use of healthcare services for the treatment of Canadian patients with prostate gland cancer which spread to other parts of the body. In order to collect this information real world data from prostate gland cancer patients from four Canadian administrative databases will be analyzed.
Data collected from patients treated with their 2nd line of life-prolonging therapy for Non-Metastatic Castration Resistant Prostate Cancer (mCRPC) initiated from 01 Jan 2012 to 31 Dec 2017. For patients included in the study, all available data from the beginning for their record until death, lost to follow-up or database cut-off will be included. The index date is the date of initiation of the 2nd line life-prolonging therapy for mCRPC.
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
- •Use of at least 2 lines of life-prolonging mCRPC therapy
- •The 2nd line of life-prolonging therapy was initiated between 01-Jan-2012 to 31-Dec-2017
排除标准
- •No formal exclusion criteria will be applied in order to capture real world use of Ra-223
研究组 & 干预措施
Early Ra-223 (2nd line)
Patients received Ra-223 in 2nd line
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
Late Ra-223 (3rd or later lines)
Patients received Ra-223 in 3rd or later lines
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Overall survival
时间窗: Retrospective analysis from 01-Jan-2012 to 31-Dec-2017
The length of time from the date of initiation of 2nd line life-prolonging therapy to death due to any cause
次要结局
- Time to first hospitalization(Retrospective analysis from 01-Jan-2012 to 31-Dec-2017)
- Event-free survival (EFS)(Retrospective analysis from 01-Jan-2012 to 31-Dec-2017)
- Time to External Beam Radiation Therapy (EBRT)(Retrospective analysis from 01-Jan-2012 to 31-Dec-2017)
- Total incidence of EBRT(Retrospective analysis from 01-Jan-2012 to 31-Dec-2017)
- Number of overnight hospital stays(Retrospective analysis from 01-Jan-2012 to 31-Dec-2017)
- Average length of hospital stays (number of days)(Retrospective analysis from 01-Jan-2012 to 31-Dec-2017)
- Time to first Emergency Room (ER) visit(Retrospective analysis from 01-Jan-2012 to 31-Dec-2017)
- Number of visits to the ER(Retrospective analysis from 01-Jan-2012 to 31-Dec-2017)