Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 2
- 主要终点
- Rate of infectious complications
研究概览
简要总结
This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy.
Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach.
This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.
详细描述
There are two ways to take biopsy (tissue) samples from the prostate. The more commonly used method is trans-rectal needle biopsy of the prostate (TR-Bx) with a needle inserted through a probe in the rectum to reach the prostate.
TR-Bx is usually performed in the office, using local anesthesia, and often using a targeted biopsy approach using MRI/ultrasound fusion technique.
Trans-perineal biopsy (TP-Bx) with a needle inserted directly through the skin to reach the prostate.
Typically, TP-BX is performed in the outpatient surgical setting due significant pain associated with the procedure, requiring the use anesthesia and/or sedation.
TP-Bx. procedure is very uncommon in the USA and is often performed using ultrasound alone (less accurate), without the benefit of MRI guided targeted biopsy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
- •Either with or without an MRI
排除标准
- •Patients with no access to rectum (due to previous rectal surgery)
- •Any abnormalities of the perineal skin (e.g. infection)
- •Patients whose procedure requires sedation or general anesthesia
结局指标
主要结局
Rate of infectious complications
时间窗: 30 days
Whether or not patient had an infection after the biopsy
Clinically significant cancer detection rate
时间窗: 14 days
The rate of grade group 2 prostate cancer detected in each study arm
次要结局
- Patient reported urinary function measures using IPSS questionaire(30 days)
- Cost of the procedures(30 days)
- Patient reported sexual function measures using IIEF questionaire(30 days)
- Rate of Bleeding complications(30 days)
- Tolerability under local anesthesia(30 days)
研究者
Badar M. Mian
Professor of Surgery
Albany Medical College