EURURO Vol. 72 No. 2

282 320

Prostate Cancer
Diagnostic Pathway with Multiparametric Magnetic Resonance
Imaging Versus Standard Pathway: Results from a Randomized
Prospective Study in Biopsy-naı¨ve Patients with Suspected
Prostate Cancer
Francesco Porpiglia Matteo Manfredi Fabrizio Mele Marco Cossu Enrico Bollito
Andrea Veltri Stefano Cirillo Daniele Regge Riccardo Faletti Roberto Passera
Cristian Fiori Stefano De Luca
a Division of Urology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy; bDivision of Pathology, University of Turin, San Luigi Gonzaga
Hospital, Orbassano, Turin, Italy; cDivision of Radiology, University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy; d Division of Radiology,
Mauriziano Hospital, Turin, Italy; e Department of Radiology, Candiolo Cancer Institute–FPO, IRCCS, Candiolo, Turin, Italy; f Department of Surgical Sciences,
Radiology Unit, University of Turin, Citta` della Salute e della Scienza, Turin, Italy; g Division of Nuclear Medicine, University of Turin, San Giovanni Battista
Hospital, Turin, Italy
available at
journal homepage:
Article info
Article history:
Accepted August 17, 2016
Associate Editor:
Giacomo Novara
Keywords:
Diagnosis
Magnetic resonance imaging
Prostate cancer
Systematic random biopsy
Targeted biopsy
Abstract
Background: An approach based on multiparametric magnetic resonance imaging (mpMRI)
might increase the detection rate (DR) of clinically significant prostate cancer (csPCa).
Objective: To compare an mpMRI-based pathway with the standard approach for the detection of
prostate cancer (PCa) and csPCa.
Design, setting, and participants: Between November 2014 and April 2016, 212 biopsy-naı¨ve
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).
Intervention: 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 armA (n = 26) with negativempMRI results and patients in armB underwent 12-core SB.
Outcomes measurements and statistical analysis: 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.
Results and limitations: 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.
Conclusions: A diagnostic pathway based on mpMRI had a higher DR than the standard pathway
in both PCa and csPCa.
Patient summary: 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.
# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.
* Corresponding author. Division of Urology, Department of Oncology, University of Turin, San Luigi
Gonzaga Hospital, Regione Gonzole 10, 10043 Orbassano, Turin, Italy. Tel. +39 0119026558;
Fax: +39 0119038654.
E-mail address: (F. Porpiglia).
0302-2838/# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.