A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Detection rate for clinically significant prostate cancer
研究概览
简要总结
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy
详细描述
This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy among men. The target population are males that are schedule to undergo MRI-US Fusion prostate biopsy and have an MRI of the prostate. All the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous MRI imaging, and defined as region of interest (ROI).
First the prostate biopsy will be preformed in a transperineal approach; Then a transrectal approach would be used to sample a few more cores.
The primary endpoint will be To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies. Additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.
- •Either primary biopsy or repeated biopsy
- •PI-RADS classification of 3-5
排除标准
- •Men who do not have an MRI of the prostate.
- •PI-RADS classification of 2 or lower
- •Men who were diagnosed with prostate cancer and have begun treatment
结局指标
主要结局
Detection rate for clinically significant prostate cancer
时间窗: within 2 years
To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.
次要结局
- Percentage of cores positive per region of interest (ROI)(within 2 years)
- Amount of volume of cores positive per region of interest (ROI)(within 2 years)