Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy

Arms (2)

1. type

   EXPERIMENTAL

   label

   MRI/ultrasound transperineal prostate biopsy

   description

   In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS\<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.

   interventionNames

   1. Device: MRI/ultrasound transperineal prostate biopsy

2. type

   ACTIVE_COMPARATOR

   label

   transrectal ultrasound-guided prostate biopsy

   description

   TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.