Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 334
- 主要终点
- Number of adverse events as a measure of safety
研究概览
简要总结
This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.
详细描述
This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months.
During the observation period (i.e. up to 6 months), safety and effectiveness information is collected. Since patient's visit occurs under the routine clinical practice, the study protocol does not define exact referral dates for those visits. The physician records patient data as defined in the protocol.
The extended follow-up period is to collect bone fractures and survival with post-treatment information after Xofigo under the real-world in Japan.
The results of this study (except of extended follow-up period) have to be submitted to the Japanese regulatory authorities as a part of the reexamination period (8 years). This study is conducted in accordance with Article 14-4 (re-examination) of the Pharmaceutical Affairs Law, and Good Post-marketing Surveillance Practice from a ministerial ordinance of Ministry of Health, Labor and Welfare in Japan.
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
- •Patients suffered from CRPC with bone metastases
- •Patients for whom the decision to initiate treatment with Xofigo is made as per physician's routine clinical practice.
- •Xofigo treatment naïve
排除标准
- •Patients treated Xofigo previously
- •Patients participating in an investigational program with interventions outside of routine clinical practice
研究组 & 干预措施
Xofigo / Cohort 1
Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice.
干预措施: Radium-223 dichloride (Xofigo, BAY 88-8223) (Drug)
结局指标
主要结局
Number of adverse events as a measure of safety
时间窗: Up to 6 months
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
Number of adverse drug reactions as a measure of safety
时间窗: Up to 6 months
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
次要结局
- Change in laboratory findings (e.g. ALP, bone markers)(From Baseline up to 6 month)
- Change in analgesic use as a surrogate of pain status(From Baseline up to 6 month)
- Survival rate(Up to 3 years)
- Post-treatment information(Up to 3 years)
- Number of patients with bone fractures(Up to 3 years)