Rates of Bone Fractures and Survival in Metastatic Castration-resistant PRostate Cancer (mCRPC) PatiEnts Treated With Radium 223 in Routine Clinical practIce in SwedEn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,434
- 试验地点
- 1
- 主要终点
- Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe
研究概览
简要总结
In this observational study researchers want to gather more information about bone fractures and survival in castration-resistant prostate cancer (CRPC) patients treated with radium-223 in routine clinical practice in Sweden. The goal is to estimate the proportion of new cases (incidence) of symptomatic bone fractures and to estimate the proportion of death occurred in years of observation time per person (person years). Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
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
- •Histologically confirmed adenocarcinoma of the prostate, i.e., the patient is registered in the NPCR (histology other than adenocarcinomas are not registered in the NPCR).
- •Start of Ra-223 treatment for mCRPC as an n-th line of treatment, where "n" goes from 1 to
- •ECOG performance status of 0-2 at treatment initiation. We will assume that patients starting any of the systemic therapies under study have a performance status of 0-2.
排除标准
- •Prior use of Ra-223
- •Patients that have participated in a Ra-223 RCT
研究组 & 干预措施
Ra-223 initiators
Patients diagnosed with mCRPC (Metastatic Castration-Resistant Prostate Cancer) who start treatment with Ra-223. Patients will be identified from the "Patient-overview Prostate Cancer" (PPC), a sub-registry of the Prostate Cancer data Base Sweden (PCBaSe) data set.
干预措施: Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
Initiators of other standard of care
The comparator cohort will be patients using standard of care other than Ra-223.
干预措施: Other standard care (Drug)
结局指标
主要结局
Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe
时间窗: Retrospectively analysis from November 2013 to December 2018
PCBaSe: Prostate Cancer data Base Sweden
次要结局
- Death due to all causes(Retrospectively analysis from November 2013 to December 2018)
- Death due to prostate cancer(Retrospectively analysis from November 2013 to December 2018)