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临床试验/NCT03366792
NCT03366792终止不适用

Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
46
试验地点
1
主要终点
Core Cancer Length

研究概览

简要总结

The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.

详细描述

Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.

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
40 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score >3/5)

排除标准

  • Prior pelvic radiotherapy
  • Evidence of urinary tract infection or significant urinary retention
  • Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI
  • No evidence of suspicious lesions on mpMRI
  • Irreversible coagulopathy
  • Contraindication to sedation

结局指标

主要结局

Core Cancer Length

时间窗: 2 Months

Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)

次要结局

  • Percentage of High-Grade Prostate Cancer Using Gleason Score(2 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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