A Prospective Randomized Trial of Prostate Biopsy Protocols Comparing the Vienna Nomogram and a Standard 10-core Biopsy Scheme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 463
- 试验地点
- 2
- 主要终点
- Prostate cancer detection rate
研究概览
简要总结
In this study, the investigators aim to determine if the Vienna nomogram increases the detection rate of TRUS-guided prostate biopsies by conducting a prospective randomized study comparing the Vienna nomogram with a 10-core biopsy protocol.
详细描述
Trans rectal ultrasound (TRUS) guided prostate biopsy remains the standard for prostate cancer diagnosis. However, the standard protocols miss 15 to 30% of cancers, leading to a variable number of repeat biopsies.
In 2005 the Vienna nomogram was introduced, defining the number of cores to be obtained in a prostate biopsy in relation to age and prostate volume in patients with a serum PSA level of 2-10 ng/mL.
The objective of the study is to determine if the Vienna nomogram increases the detection rate of trans rectal ultrasound guided prostate biopsies, compared to a 10-core biopsy.
This prospective randomized study enrolled men eligible for a prostate biopsy were randomized to a Vienna nomogram protocol or a 10-core protocol. They were further stratified according to age (≤65; >65 and ≤70; >70 years) and prostate volume (≤30; >30 and ≤50; >50 and ≤70; >70 cc).
A subgroup analysis for patients with serum PSA values between 2 and 10 ng/mL was performed.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PSA elevation
- •Abnormal digital rectal examination
- •Abnormal findings on prostate imaging
排除标准
- •Active urinary tract infection
- •Documented previous pathological prostatitis
- •History of urinary retention
- •Recent lower urinary tract surgery
研究组 & 干预措施
10-core prostate biopsy protocol group
Ultrasound guided prostate biopsy with extraction of 10 cores
干预措施: 10-core prostate biopsy protocol (Procedure)
Vienna nomogram prostate biopsy protocol group
Ultrasound guided prostate biopsy performed according to the Vienna nomogram
干预措施: Vienna nomogram prostate biopsy protocol (Procedure)
结局指标
主要结局
Prostate cancer detection rate
时间窗: Up to four weeks after intervention
次要结局
- Prostate cancer detection rate in prostate volume and age subclasses(Up to four weeks after intervention)
- Gleason score concordance between biopsy and prostatectomy specimens(Up to four weeks after prostatectomy)
研究者
Tito Palmela Leitão
Dr.
Hospital de Santa Maria, Portugal