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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04291742
Study type Interventional
Source Hospital Universitari Vall d'Hebron Research Institute
Contact Ana Celma, MD
Phone 0034932746000
Email acelma@vhebron.net
Status Recruiting
Phase N/A
Start date January 16, 2020
Completion date February 27, 2022

See also
  Status Clinical Trial Phase
Completed NCT02013180 - Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection