title: Diagnostic Pathway with Multiparametric Magnetic Resonance Imaging Versus Standard Pathway: Results from a Randomized Prospective Study in Biopsy-naïve Patients with Suspected Prostate Cancer.
abstract: An approach based on multiparametric magnetic resonance imaging (mpMRI) might increase the detection rate (DR) of clinically significant prostate cancer (csPCa).
  
  
  
  To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa.
  
  
  
  Between November 2014 and April 2016, 212 biopsy-naïve patients with suspected PCa (prostate specific antigen level ≤15 ng/ml and negative digital rectal examination results) were included in this randomized clinical trial. Patients were randomized into a prebiopsy mpMRI group (arm A, n=107) or a standard biopsy (SB) group (arm B, n=105).
  
  
  
  In arm A, patients with mpMRI evidence of lesions suspected for PCa underwent mpMRI/transrectal ultrasound fusion software-guided targeted biopsy (TB) (n=81). The remaining patients in arm A (n=26) with negative mpMRI results and patients in arm B underwent 12-core SB.
  
  
  
  The primary end point was comparison of the DR of PCa and csPCa between the two arms of the study; the secondary end point was comparison of the DR between TB and SB.
  
  
  
  The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; p=0.002) and csPCa (43.9% vs 18.1%, respectively; p<0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; p<0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; p<0.001). The reproducibility of the study could have been affected by the single-center nature.
  
  
  
  A diagnostic pathway based on mpMRI had a higher DR than the standard pathway in both PCa and csPCa.
  
  
  
  In this randomized trial, a pathway for the diagnosis of prostate cancer based on multiparametric magnetic resonance imaging (mpMRI) was compared with the standard pathway based on random biopsy. The mpMRI-based pathway had better performance than the standard pathway.
authors: Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy. Electronic address: porpiglia@libero.it.
authors: Francesco
authors: F
authors: Porpiglia
authors: Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
authors: Matteo
authors: M
authors: Manfredi
authors: Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
authors: Fabrizio
authors: F
authors: Mele
authors: Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
authors: Marco
authors: M
authors: Cossu
authors: Division of Pathology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
authors: Enrico
authors: E
authors: Bollito
authors: Division of Radiology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
authors: Andrea
authors: A
authors: Veltri
authors: Division of Radiology, Mauriziano Hospital, Turin, Italy.
authors: Stefano
authors: S
authors: Cirillo
authors: Department of Radiology, Candiolo Cancer Institute-FPO, IRCCS, Candiolo, Turin, Italy.
authors: Daniele
authors: D
authors: Regge
authors: Department of Surgical Sciences, Radiology Unit, University of Turin, Città della Salute e della Scienza, Turin, Italy.
authors: Riccardo
authors: R
authors: Faletti
authors: Division of Nuclear Medicine, University of Turin, San Giovanni Battista Hospital, Turin, Italy.
authors: Roberto
authors: R
authors: Passera
authors: Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
authors: Cristian
authors: C
authors: Fiori
authors: Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.
authors: Stefano
authors: S
authors: De Luca
mesh_terms: D000368:Aged; D001706:Biopsy; D019091:Critical Pathways; D006801:Humans; D007610:Kallikreins / Q000097:blood; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D011237:Predictive Value of Tests; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000000981:diagnostic imaging* / Q000473:pathology*; D015203:Reproducibility of Results
chemical_list: C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen
keywords: Diagnosis; Magnetic resonance imaging; Prostate cancer; Systematic random biopsy; Targeted biopsy