Spots Global Cancer Trial Database for Comparison of Prostate Fusion Biopsies With Software and Cognitive

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Trial Identification

Brief Title: Comparison of Prostate Fusion Biopsies With Software and Cognitive

Official Title: 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

Study ID: NCT04291742

Conditions

Prostate Cancer Detection

Fusion Prostate Biopsy

Interventions

cognitive vs software

Study Description

Brief 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.

Detailed 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.