Prospective and Randomized Study to Compare the Efficacy of Cognitive Fusion Prostate Biopsies and Prostate Biopsies Performed by "BK-fusion®" Software, for the Diagnosis of Significant Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 804
- 试验地点
- 2
- 主要终点
- Rate of overall prostate cancer and significant prostate cancer between the groups
研究概览
简要总结
This study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.
详细描述
Various techniques have been developed to perform targeted prostate biopsies aimed at suspicious lesions detected in mpMRI. The two most frequently used are cognitive fusion, in which the physician locates the areas where the mpMRI detects suspicious lesions and directs the puncture by ultrasound; and software fusion, in which the images of the mpMRI are integrated by a software with the ultrasound allowing to direct the puncture to the lesion itself. Both forms of fusion biopsy have proven to be superior to systematized prostate biopsies in the detection of significant prostate cancer, although neither has demonstrated superiority over the other.
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
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age over 40 years.
- •mpMRI carried out in our center.
- •Presence of lesions with PIRADSv.2 ≥
- •Acceptance to participate in the study.
排除标准
- •PSA> 30 ng / ml
- •Treatment with 5-ARIs (5-alpha-reductase inhibitors).
- •Previous diagnosis of PCa.
结局指标
主要结局
Rate of overall prostate cancer and significant prostate cancer between the groups
时间窗: 2 years
Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed.
次要结局
- Rate of overall prostate cancer and significant prostate cancer between the groups according to the prostate volume.(2 years)
- Rate of overall prostate cancer and significant prostate cancer between the groups according to the PIRADS (prostate imaging and reporting and data System) of the lesions.(2 years)
- Rate of overall prostate cancer and significant prostate cancer between the groups according to the location of the lesions.(2 years)
- Rate of overall prostate cancer and significant prostate cancer between the groups according to the size of the lesions.(2 years)