Drug utilisatIon Study of Radium 223 Under Routine Clinical Practice in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,067
- 试验地点
- 1
- 主要终点
- The proportion of patients who use radium-223 in combination with abiraterone acetate
研究概览
简要总结
In this study data from people with metastatic castration-resistant prostate cancer (mCRPC) with bone metastasis are studied. mCRPC is a prostate cancer which has spread to other parts of the body even when the amount of testosterone in the body was reduced. Bone metastasis is when the cancer has spread to the bones.
The study drug, radium-223, is currently available as a treatment for mCRPC with bone metastasis. But, its combination with certain other cancer treatments may lead to medical problems. Therefore the instructions about how doctors should use radium-223 with other cancer treatments were changed.
In this study, the researchers want to learn more about how doctors are now using radium-223 to treat patients with mCRPC and bone metastasis.
The participants in this study will include men in Denmark, Germany, or the Netherlands. They will not have received radium-223 before. They will have at least 6 months of medical records before starting treatment with radium-223. The researchers will collect the participants' medical records up to December 2020.
The researchers will review information from the participants' medical records and medical claims from hospitals where the participants received radium-223. They will look at the medical records of participants who first started receiving radium-223 before there were new instructions about using it with other cancer treatments. They will also look at the medical records of participants who first started receiving radium-223 after there were new instructions.
They will then count how many participants received other specific cancer treatments with radium-223. They will compare the results of the participants' who received radium-223 before the new instructions and those who received it after the new instructions.
There are no required visits or tests in this study.
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
- •Patients who receive a first dispensing/administration of radium-223 during the before or after study period
- •Patients who have at least 6 months of continuous enrolment in the study databases before the first dispensing/administration of radium-223 (to allow for evaluation of recent medical history and medication use)
排除标准
- •Patients who used radium-223 ever before the start of the before study period
研究组 & 干预措施
Radium-223
Subjects who received the treatment of radium-223 during the before or after label change study periods.
干预措施: Radium 223 dichloride (Xofigo, BAY88-8223) (Drug)
结局指标
主要结局
The proportion of patients who use radium-223 in combination with abiraterone acetate
时间窗: Data will be collected from Nov 2013 to Dec 2020
The proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues
时间窗: Data will be collected from Nov 2013 to Dec 2020
The proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues
时间窗: Data will be collected from Nov 2013 to Dec 2020
次要结局
- The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with abiraterone acetate(Data will be collected from Nov 2013 to Dec 2020)
- The difference between before and after the label change periods in the proportion of patients who use radium-223 in combination with other systemic therapies for mCRPC, except luteinising hormone-releasing hormone (LHRH) analogues(Data will be collected from Nov 2013 to Dec 2020)
- The difference between before and after the label change periods in the proportion of patients who use radium-223 without having received at least two prior lines of systemic therapy for mCRPC, except LHRH analogues(Data will be collected from Nov 2013 to Dec 2020)