A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time to symtomatic skeletal event(SSE)
研究概览
简要总结
The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.
The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.
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
- •Received at least one dose of radium-223 after mCRPC diagnosis
- •Received at least one prescription or dose of chemotherapy for treatment of mCRPC
排除标准
- •No documented visceral metastasis at initiation of radium-223
研究组 & 干预措施
Ra-223 therapy before chemotherapy
Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy
干预措施: Xofigo (Drug)
Ra-223 therapy before chemotherapy
Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy
干预措施: Taxotere (Drug)
Ra-223 therapy before chemotherapy
Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy
干预措施: Jevtana (Drug)
Ra-223 after chemotherapy
Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
干预措施: Xofigo (Drug)
Ra-223 after chemotherapy
Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
干预措施: Taxotere (Drug)
Ra-223 after chemotherapy
Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
干预措施: Jevtana (Drug)
结局指标
主要结局
Time to symtomatic skeletal event(SSE)
时间窗: Up to 30 months
Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
Reasons for treatment discontinuation
时间窗: Up to 30 months
data for treatment discontinuation for each mCRPC therapy will be collected
Overall survival
时间窗: Up to 30 months
Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).
次要结局
- Number of hospitalizations(Up to 30 months)
- PSA PFS(Up to 30 months)
- Non-laboratory based clinically relevant safety outcomes(Up to 30 months)
- Laboratory-based outcomes collected by questionnaire(Up to 30 months)
- Treatments received(Up to 30 months)
- hospital length of stay(Up to 30 months)