NCT03563014已完成不适用
A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections
研究概览
简要总结
The aim of this non interventional study is to describe the proportion of Belgian mCRPC patients which were treated with 1 to 4 and 5 to 6 Radium-223 injections and the patient characteristics which are potentially associated with this proportion.
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 a diagnosis of castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases
- •All consecutive patients who started Radium-223 treatment between 22 December 2014 and 01 June 2017
- •Availability of medical records during the observation period (22DEC2013 - 01JUN2018)
排除标准
- •Patients treated with Radium-223 for any reason before 22 December 2014 (for example an interventional trial)
- •Patients participated in an investigational program with interventions outside of routine clinical practice during the radium-223 treatment period
- •Patients received other radiopharmaceuticals for the systemic concomitant use for treatment of prostate cancer or for other use during the Radium-223 treatment period
研究组 & 干预措施
Radium-223 (Xofigo, Bay88-8223)
Belgium patients with a diagnosis of mCRPC (no known visceral metastases) and who were treated with Radium-223 for this indication
干预措施: Radium-223 (Xofigo, Bay88-8223) (Drug)
结局指标
主要结局
The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections
时间窗: Retrospectively analysis from 22 December 2013 to 01 June 2018
次要结局
- The number of prior and post life prolonging systemic anti-cancer therapies will be described(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The occurrence of SSE related hospitalizations(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The overall survival in routine clinical practice(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The characteristics of patients according to the experience of the study centers with Radium-223(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The frequency of blood transfusions(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The timing of progression post first dose of Radium-223(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The frequency of SSE related hospitalizations(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The number of patients receiving first- and second-line systemic anti-cancer treatment in mCRPC(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The number of patients receiving next line of systemic anti-cancer therapy(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The occurrence of progression post first dose of Radium-223(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The number of discontinuation of Radium-223(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The proportion of patients with 5-6 Radium-223 injections versus 1-4 Radium-223 injections by Radium-223 line of treatment (1st, 2nd and further line)(Retrospectively analysis from 22 December 2013 to 01 June 2018)
- The time between last Radium-223 injection and next line of systemic anti-cancer therapy(Retrospectively analysis from 22 December 2013 to 01 June 2018)
研究者
研究点 (1)
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