NCT01553838已完成不适用
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Prostate cancer detection rate
研究概览
简要总结
The purpose of this study is to determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values > 4.0 ng/ml.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •PSA > 4.0 ng/ml
- •written informed consent
排除标准
- •patients with prostate cancer
- •patients with prior prostate biopsy
- •patients with contraindications against MRI or biopsy
研究组 & 干预措施
Sequentially MRI guided and TRUS guided biopsy
Experimental
Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy
干预措施: MRI guided prostate biopsy and TRUS guided biopsy (Device)
结局指标
主要结局
Prostate cancer detection rate
时间窗: 3 years
次要结局
- Number of Participants with Adverse Events as a measure of Safety and Tolerability(3 years)
研究者
研究点 (2)
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