Post-eRADicAte: A Long Term Follow up to eRADicAte (NCT 02097303), an Open Label Phase Two Study of RADium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in CRPC Subjects With Symptomatic Bone Metastasis.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 31
- 试验地点
- 5
- 主要终点
- To investigate the overall survival of subjects that completed the "eRADicAte" study.
研究概览
简要总结
This is a Long Term Follow Up study to eRADicAte, an open label study designed to examine the effects of Radium Ra 223 dichloride with concurrent administration of Abiraterone Acetate plus Prednisone Castrate-Resistant (Hormone-Refractory) Prostate Cancer subjects with symptomatic bone metastasis.
详细描述
This is a Long Term Follow Up study to eRADicAte, an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases.
31 subjects completed all study visits in the eRADicAte study, and were thus evaluable. All 31 subjects will be asked to participate in this Long Term Follow Up study which will evaluate overall survival, subsequent additional prostate cancer therapies and medications, radiographic changes and SSE's (Symptomatic Skeletal Events), incidence of bone marrow failure, and diagnosis with secondary malignancies.
Living subjects will be evaluated at least 12 weeks after their last dose of Radium Ra 223 dichloride and at each subsequent clinic visit. Deceased subject's data will be obtained retrospectively, from 12 weeks after the eRADicAte End of Treatment visit and prospectively through the date of death. The total duration of the study is expected to be 48 months
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects are adults over the age of 18 with mCRPC that completed the eRADicAte study. The living study subject or legally authorized representative must be able to understand and sign the written informed consent form.
排除标准
- •A living study subject or his legally authorized representative are not able to understand or willing to sign the written informed consent form.
结局指标
主要结局
To investigate the overall survival of subjects that completed the "eRADicAte" study.
时间窗: From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years
Long term follow up
To investigate subsequent prostate cancer therapies and medications of subjects that completed the "eRADicAte" study.
时间窗: From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years
Long term follow up
To investigate radiographic changes of subjects that completed the "eRADicAte" study.
时间窗: From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years
Long term follow up
To investigate SSE's of subjects that completed the "eRADicAte" study
时间窗: From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years
Long term follow up
To investigate the incidence of bone marrow failure of subjects that completed the "eRADicAte" study.
时间窗: From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years
Long term follow up
To investigate the occurence of subsequent diagnosis with secondary malignancies of subjects that completed the "eRADicAte" study.
时间窗: From the end of "eRADicAte" study, subjects will be followed retroactively from the time they completed the study and proactively for up to 4 years
Long term follow up
次要结局
未报告次要终点