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1.

Introduction

Prostate cancer (PCa) is the second leading cause of cancer-

related mortality in Western men

[1]

. With the recent

technological advancements and growing availability,

multiparametric magnetic resonance imaging (mpMRI)

currently is increasingly being used for guiding several

aspects of PCa management, including detection, staging,

and treatment planning

[2]

. Despite abundant evidence in

the literature reporting high accuracy of mpMRI for PCa

diagnosis, widespread acceptance has been hampered by

several factors including difficulty of interpretation, lack of

standardized criteria for interpretation (ie, use of Likert

scales based on the radiologist’s subjective level of

suspicion for PCa), and resulting substantial inter-reader

variability

[3,4]

.

To bring standardization to the evaluation and

reporting of mpMRI of the prostate, the European Society

of Urogenital Radiology (ESUR) published a guideline

termed Prostate Imaging Reporting and Data System (PI-

RADS) in 2012

[5]

. PI-RADS was generated based on

expert consensus and provides a detailed scoring system

for each MRI sequence (T2-weighted imaging [T2WI],

diffusion-weighted imaging [DWI], dynamic contrast-

enhanced MRI [DCE-MRI], and MR spectroscopy) for the

presence of clinically significant PCa (csPCa). Several

investigators have validated the accuracy and reproduc-

ibility of PI-RADS, and a recent meta-analysis reported

pooled sensitivity and specificity of 0.78 and 0.79,

respectively

[6]

. However, as there was no guideline for

the generation of an overall score, different research

groups utilized various measures for this purpose—some

used a sum of the scores from each sequence (ranging

from 3 to 15), whereas others used an overall score of 1–5

[7,8] .

Furthermore, emerging data questioned the value of

curve-type analysis of DCE-MRI

[9] .

In addition, investi-

gators suggested that some sequences may be more

important in determining the likelihood of PCa (ie, DWI in

the peripheral zone [PZ] and T2WI in the transition

zone [TZ]) rather than equal weighting for all sequences

[10]

.

To address these issues, the ESUR and American College

of Radiology recently released the updated PI-RADS version

2 (PI-RADSv2)

[11]

. The main changes fromPI-RADSv1 to PI-

RADSv2 are the following: (1) introduction of dominant

sequences according to zonal anatomy (DWI for the PZ and

T2WI for the TZ), (2) limited contribution of DCE-MRI data

as merely presence and absence of early focal enhancement,

and (3) generation of an overall score (1–5) integrating

findings across all MRI sequences.

Since then, several studies assessing the value of PI-

RADSv2 have been published. However, the diagnostic

performance of this new scoring system has not been

evaluated systematically. Therefore, the purpose of our

study was to assess the diagnostic performance of PI-

RADSv2 for the detection of PCa. In addition, we aimed

to compare the diagnostic performance of PI-RADSv1

and PI-RADSv2 in studies available for head-to-head

comparison.

2.

Evidence acquisition

This meta-analysis was performed and written according to

the preferred reporting items for systematic reviews and

meta-analyses (PRISMA) guidelines

[12]

.

2.1.

Literature search

A computerized search of MEDLINE and EMBASE up to

December 7, 2016, was performed in order to identify

studies evaluating the diagnostic performance of PI-RADSv2

for the detection of PCa. The search query combined

synonyms for PCa, MRI, and PI-RADS as follows: (prostate

cancer OR prostatic cancer OR prostate neoplasm OR

prostatic neoplasm OR prostate tumor OR prostatic tumor

OR prostate carcinoma OR prostatic carcinoma OR PCa) AND

(magnetic resonance imaging OR MRI OR MR) AND

(prostate imaging reporting and data system OR pi-rads

OR pi rads OR pirads). Bibliographies of identified articles

were also screened to expand the scope of search. Our

search was limited to publications in English.

2.2.

Study selection

2.2.1.

Inclusion criteria

Studies were included if they satisfied all the following

requirements according to the PICOS criteria

[12]

: (1)

included patients with suspected or diagnosed PCa; (2) for

index test, mpMRI of the prostate including all required

sequences of T2WI, DWI, and DCE-MRI was performed and

assessed with a PI-RADSv2 scoring system; (3) for

comparison, a reference standard based on the histopatho-

logical examination of radical prostatectomy or biopsy was

used; (4) results were reported in sufficient detail for the

reconstruction of 2 2 tables and determination of

sensitivity and specificity at specified cutoff values for

evaluating the diagnostic performance of PI-RADSv2; and

(5) studies had to be original articles.

2.2.2.

Exclusion criteria

Studies were excluded if any of the following criteria were

met: (1) studies involving

<

10 patients; (2) review articles,

guidelines, consensus statements, letters, editorials, and

conference abstracts; (3) studies using only PI-RADSv1 for

the evaluation of mpMRI of the prostate; (4) studies focusing

on topics other than using the PI-RADSv2 system for

diagnosing PCa (ie, staging and prediction of biochemical

recurrence); and (5) studies with overlapping patient

population.

Two reviewers (S.W. and C.H.S., with 3 yr of experience in

performing systematic reviews and meta-analyses) inde-

pendently evaluated the eligibility of the selected studies

from the literature. Disagreements, if present between the

two reviewers, were resolved by consensus via discussion

with a third reviewer (S.Y.K.).

2.3.

Data extraction and quality assessment

We extracted the following data regarding study design and

results from the selected studies using a standardized form:

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