NCT05025527尚未招募不适用
Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study
Shanghai East Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The proportion of men with clinically significant cancer
研究概览
简要总结
This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 80 years old
- •life-expectancy at least 10 years
- •fully understand the clinical trial protocol and sign the informed consent;
排除标准
- •Already diagnosis with prostate cancer;
- •cannot tolerate prostate biopsy or has contraindication to biopsy;
- •cannot tolerate prostate biopsy or has contraindication to MRI examination;
- •undergo biopsy within 1 year
- •patients judged by the investigator to be unsuitable to participate in the clinical trial;
结局指标
主要结局
The proportion of men with clinically significant cancer
时间窗: Within 1 month after the biopsy
The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 2 or more
次要结局
- The proportion of men with clinically insignificant cancer(Within 1 month after the biopsy)
- The proportion of men who do not undergo biopsy(Within 1 month after the biopsy)
- The proportion of men with adverse events after the intervention(Within 1 week after the biopsy)
研究者
研究点 (1)
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