Magnetic Resonance Imaging Targeted (fusion) Versus Cognitive Prostatic Biopsy in Biopsy-naïve Suspected Cancer Prostate Patient a Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- detection of clinically significant prostate cancer
研究概览
简要总结
The aim of the present study is to compare the accuracy of Magnetic resonance imaging targeted (fusion) versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient
详细描述
Prostate cancer is the second most frequent malignancy (after lung cancer) in men worldwide, counting 1,276,106 new cases and causing 358,989 deaths (3.8% of all deaths caused by cancer in men.
The clinical prostate cancer detection rate of TRUS-guided needle biopsies is only 25-30%. while more than 50% of cancers that require definitive treatment remain undetected during initial biopsies .
Clinical studies have shown that 75-80% of non-palpable carcinomas remain undetected during initial prostate biopsies.
Multi-parametric prostate MRI has a high sensitivity for the detection of prostate adenocarcinoma and has shown promise for targeted biopsy of lesions that may be missed on routine systematic trans -rectal ultrasound (TRUS) biopsy .
The most recent European Association of Urology guidelines recommend MRI before prostate biopsy for biopsy-naïve men with elevated PSA, the strength rating of the recommendation is weak.
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
- Single (Participant)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •prostate biopsy-naïve men
- •PSA levels of up to 20 ng/mL
- •Multi-parametric prostate MRI revealed a PIRAD 4 or PIRAD 5.
排除标准
- •PSA level greater than 20 ng/mL
- •patient with history of TRUS biopsy
- •patient diagnosed as cancer prostate or with distant metastasis
结局指标
主要结局
detection of clinically significant prostate cancer
时间窗: two weeks
accuracy of MRI targeted fusion versus cognitive prostatic biopsy in biopsy-naïve suspected cancer prostate patient to detect clinically significant prostate cancer
次要结局
未报告次要终点
研究者
Ahmed Mohamed Shebl Mehanna
Doctor
Menoufia University