An Exploratory Study of Optimizing the Core Number and Location for MRI/Ultrasound Fusion Targeted Prostate Biopsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area
研究概览
简要总结
This study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.
详细描述
This is a single-center prospective study. The investigators perform MRI/US image fusion targeted saturation biopsy on prostate lesions with PI-RADS score 4, to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men more than 18 years old with clinical suspicion of prostate cancer;
- •Serum PSA ≤ 20 ng/ml within the previous 3 months;
- •No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- •mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm；
- •Able to provide written informed consent.
排除标准
- •Prior prostate biopsy or prostate surgery;
- •Prior treatment for prostate cancer;
- •Contraindication to MRI (e.g. claustrophobia, pacemaker);
- •Contraindication to prostate biopsy;
- •Men in whom artifact would reduce the quality of the MRI.
研究组 & 干预措施
MRI/Ultrasound Fusion Saturation Biopsy
干预措施: MRI/Ultrasound Fusion Saturation Biopsy (Procedure)
结局指标
主要结局
The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area
时间窗: When histology results available, at an expected average of 3 days post-biopsy
次要结局
未报告次要终点
研究者
Hongqian Guo
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School