Biopsy diagnosis of prostate cancer in patients with suspected prostate cancer undergoing their first biopsy: comparison of target biopsy alone vs target biopsy in addition to standard biopsy

INTERVENTION: The primary objective of the study is to compare, in naïve patients with positive MRI, the detection rate of clinically significant prostate cancer of a diagnostic pathway based on target biopsy samples vs a diagnostic pathway based on target biopsy samples plus random samples. The patients underwent two‐arm randomization via specific "query" to the website https://www.randomization.com. Patients were randomly assigned to undergo fusion biopsy alone (Group A) or fusion biopsy plus standard biopsy (Group B). Transrectal ultrasound was performed using a Hawk Ultrasound scanner 2102 EXL with a biplanar transducer, biopsies were performed using a disposable 18‐gauge biopsy gun with a specimen size of 18–22 mm. Fusion biopsy was executed using the BioJet fusion system, for patients enrolled in Group B, in accordance with the protocol by Rodríguez‐Covarrubias et al, a standard biopsy was performed obtaining 12 cores via a transrectal approach. The Gleason score (GS) of the biopsy, number of total and positive cores, total and maximum cancer core length (CCL) and maximum cancer core invasion (CCI) rate were acquired in accordance with the standards of reporting for MRI targeted biopsy studies (START) criteria. Clinical significant Prostate Cancer (csPCa) was defined when START criteria for target biopsy (biopsy GS =7 or maximum CCL =5 mm) and updated Epstein criteria for Standard Biopsy were met. Prostate specimens from patients who underwent robot‐assisted radical prostatectomy (RARP) were chosen as the reference standard. The organ’s processing was executed following the aforementioned technique, subsequently calculating GS and ISUP grade for each lesion found. 30‐days biopsy related complications were classified according to the Clavien–Din CONDITION: Prostate cancer ; Cancer ; Malignant neoplasm of prostate PRIMARY OUTCOME: Detection rate (DR) of clinically significant prostate cancer (csPCa) by fusion biopsy alone (Group A) versus fusion biopsy plus standard biopsy (Group B), set as the ratio between the total cases of csPCs diagnosed and the total number of patients. Evaluated after the histological examination. SECONDARY OUTCOME: ; 1. 30‐days biopsy related complications classified according to the Clavien–Dindo classification at 30‐days follow up; 2. The overall DR of prostate cancer by fusion biopsy alone (Group A) versus fusion biopsy plus standard biopsy (Group B). Evaluated after the histological examination.; 3. Whole‐mount histopathological findings after RARP compared with biopsy findings in both study groups, evaluated after the histological examination; INCLUSION CRITERIA: 1. Age <75 years 2. Negative history of previous prostate biopsies 3. Suspected serum prostate‐specific antigen (PSA) values <15 ng/ml 4. Negative rectal examination (DRE) 5. Positive multiparametric magnetic resonance imaging