A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,976
- 试验地点
- 250
- 主要终点
- To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects
研究概览
简要总结
The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.
详细描述
Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •subjects must be at least 18 years of age
- •subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment
- •subjects must understand and sign an informed consent form
排除标准
- 未提供
结局指标
主要结局
To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects
时间窗: Every 3 months for a minimum of 3 years
The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.
次要结局
- Survival(Every 3 months for a minimum of 3 years)