Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
详细描述
The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan.
The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases
- •Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator
- •No contra-indications according to the local marketing authorization
排除标准
- •Previously treated with Radium-223 for any reason
- •Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period
研究组 & 干预措施
CRPC patients
Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 7 months
Incidence of drug-related TEAEs
时间窗: Up to 7 months
Descriptive analysis of long-term safety information during the extended follow-up period
时间窗: Up to 2 years
This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.
次要结局
- Proportion of patients with total ALP (tALP) response(Up to 2 years)
- Change in pain status(Up to 2 years)
- Overall survival(Up to 2 years)
- Time to the first symptomatic skeletal event (SSE)(Up to 2 years)
- Proportion of patients with PSA response(Up to 2 years)
- Change in ECOG-PS(Up to 2 years)