NCT02516709已完成不适用
CivaString Registry for Prostate Cancer
CivaTech Oncology3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Biochemical Response Rate (PSA)
研究概览
简要总结
Ongoing follow up for subjects implanted with the Linear Source String for prostate cancer.
详细描述
This registry is being conducted to provide long term analysis on the use of the linear Civastring source for prostate cancer. Prospective data collection will record and demonstrate biochemical response rates. Long term side effects and adverse events will be monitored.
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
- •Age > 18 years old
- •Plans to remain in care of enrolling physician for 5 years
- •> 5 years life expectancy
- •Signed informed consent
- •Enrolled within 6 weeks of implant or within 365 days of prior implant
排除标准
- •Not willing or able to comply with protocol visit schedule
结局指标
主要结局
Biochemical Response Rate (PSA)
时间窗: Up to 5 years
次要结局
- Side Effects (IPSS, IIEF, RFAS score)(Up to 5 years)
- Adverse Events(Up to 5 years)
研究者
研究点 (3)
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