Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Clinically significant prostate cancer detection rate
研究概览
简要总结
The aim of this study is to compare clinically significant prostate cancer detection rate by the 4 biopsy methods: TRUS-guided, cognitive, fusion and transperineal template mapping biopsy.
It is recommended to combine MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) biopsy for high yield of prostate cancer diagnosis. Nevertheless, it remains unclear which biopsy combination is more precise for prostate cancer detection.
详细描述
Taking into consideration the variety of prostate biopsy methods (TRUS-guided, cognitive, fusion and transperineal template mapping biopsy), the issue of indications for each of them remains unresolved. Current EAU guidelines recommend combining MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) one for high yield of prostate cancer diagnosis. Nevertheless, it also remains unclear which biopsy combination is more precise for prostate cancer detection.
This is a prospective single-arm study.
All patients underwent prostate TRUS examination and mpMRI. Suspicious lesion found on MRI were classified with the Pi-RADS v2.1. First step: the "unblinded" urologist №1 performed a fusion and transperineal template mapping biopsy. Second step: the "blinded" urologist №2 performed TRUS-guided and cognitive biopsy.
Objectives of the study: to determine clinically significant prostate cancer detection rate, overall cancer detection rate, clinically insignificant prostate cancer detection rate, sampling efficiency (positive biopsy cores' number, maximum cancer core length (MCCL)). Results were calculated for each biopsy method separately and for combinations of TRUS-guided and cognitive biopsy (combination №1) and fusion and transperineal template mapping biopsy (combination №2).
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
盲法说明
The "blinded" urologist performed TRUS-guided and cognitive biopsy without prior knowledge about MRI results
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
- •PSA >2 ng/mL, and/or positive digital rectal examination (DRE), and/or suspicious lesion on TRUS
- •Pi-RADSv2.1 ≥3 score
排除标准
- •previously diagnosed PCa;
- •acute prostatitis within the last 3 months;
- •5-α reductase inhibitors therapy within the last 6 months;
- •extracapsular extension;
- •prostate volume ≥80 cc;
- •contraindications for mpMRI.
结局指标
主要结局
Clinically significant prostate cancer detection rate
时间窗: 2 weeks after performed 4 biopsy methods
Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically significant prostate cancer (ISUP ≥2) in relation to total number of patients
次要结局
- Predicting factors of PCa detection(2 weeks after performed 4 biopsy methods)
- Positive biopsy cores' number(2 weeks after performed 4 biopsy methods)
- Maximum cancer core length(2 weeks after performed 4 biopsy methods)
- Number of missed clinically significant prostate cancer(2 weeks after performed 4 biopsy methods)
- Comparison of biopsies and post-prostatectomy pathological results(2 weeks after radical prostatectomy)
- Overall prostate cancer detection rate(2 weeks after performed 4 biopsy methods)
- Added value of prostate cancer(2 weeks after performed 4 biopsy methods)
- Clinically insignificant prostate cancer detection rate(2 weeks after performed 4 biopsy methods)
研究者
Dmitry Enikeev, MD, PhD
Professor
Medical University of Vienna