1.
Introduction
A correlation with radical prostatectomy specimens has
demonstrated that multiparametric magnetic resonance
imaging (mpMRI) has excellent sensitivity in detecting
prostate cancer (PCa) with a Gleason score of 7
[1–3]. As a
result, prostate mpMRI is increasingly used in patients with
a suspicion of PCa to localise abnormal areas before biopsy.
A large body of literature has shown that targeted biopsies
of suspicious lesions seen on mpMRI (TBx) improved the
detection of clinically significant PCa (csPCa), at least in the
repeat biopsy setting
[4–6]. As a result, it is now
recommended that an mpMRI is performed before repeat
biopsy to allow TBx of suspicious lesions in addition to
standard biopsies
[7].
Some authors have recently suggested that, besides
improving csPCa detection, mpMRI could also be used as a
triage test so that patients with negative mpMRI findings
could obviate biopsy. Such a strategy remains highly
controversial
[8]and depends upon the negative predictive
value (NPV) of mpMRI. Therefore, the European Association
of Urology Prostate Cancer Guidelines Panel undertook this
systematic review and meta-analysis to assess the NPV of
mpMRI in patients with a suspicion of PCa and, thus, its
potential role in eliminating unnecessary prostate biopsy.
2.
Evidence acquisition
2.1.
Objective
Our primary aim was to systematically evaluate the
performance of negative prebiopsy prostate mpMRI in
predicting a negative biopsy result for overall PCa and csPCa
in biopsy-naı¨ve men and in men with previously negative
biopsies. A further objective was to explore and define
factors that may contribute to relevant thresholds in order
to provide guidance for future studies.
2.2.
Data acquisition and search strategy
The review was performed according to the Preferred
Reporting Items for Systematic Reviews and Meta-Analysis
(PRISMA) statement
[9] .The review protocol was published
in PROSPERO database (
http://www.crd.york.ac.uk/ PROSPERO;registration number CRD42015021929). Data-
bases searched included the Embase and OVID Medline
databases, the Cochrane database of systematic reviews,
and the Cochrane Central Register for Clinical Trials,
covering from January 1, 2000 to February 13, 2016. Sys-
tematic or standard prostate biopsies were used as
reference standards, with positive or negative cases of
PCa being determined by histopathological examination.
The detailed search strategy is presented in Supplement 1.
2.3.
Inclusion and exclusion criteria
Included studies focused on men who were assessed for
suspected PCa by mpMRI before undergoing prostate
biopsy. Studies enrolling both biopsy-naı¨ve men and men
who had undergone previous negative biopsies were
included. Prebiopsy prostate mpMRI was considered the
index test and comprised T2-weighted imaging (T2WI) and
at least one functional imaging technique (diffusion-
weighted imaging [DWI], dynamic contrast-enhanced
imaging [DCEI], or magnetic resonance spectroscopic
imaging [MRSI]). For inclusion, studies had to report on
and results reported at patient level for the detection of overall PCa or clinically significant
PCa (csPCa) defined as Gleason 7 cancer.
Evidence synthesis:
A total of 48 studies (9613 patients) were eligible for inclusion. At
patient level, the median prevalence was 50.4% (interquartile range [IQR], 36.4–57.7%) for
overall cancer and 32.9% (IQR, 28.1–37.2%) for csPCa. The median mpMRI NPV was 82.4%
(IQR, 69.0–92.4%) for overall cancer and 88.1% (IQR, 85.7–92.3) for csPCa. NPV significantly
decreased when cancer prevalence increased, for overall cancer (
r
= –0.64,
p
<
0.0001) and
csPCa (
r
= –0.75,
p
= 0.032). Eight studies fulfilled the inclusion criteria for meta-analysis.
Seven reported results for overall PCa. When the overall PCa prevalence increased from 30%
to 60%, the combined NPV estimates decreased from 88% (95% confidence interval [95% CI],
77–99%) to 67% (95% CI, 56–79%) for a cut-off score of 3/5. Only one study selected for meta-
analysis reported results for Gleason 7 cancers, with a positive biopsy rate of 29.3%. The
corresponding NPV for a cut-off score of 3/5 was 87.9%.
Conclusions:
The NPV of mpMRI varied greatly depending on study design, cancer preva-
lence, and definitions of positive mpMRI and csPCa. As cancer prevalence was highly
variable among series, risk stratification of patients should be the initial step before
considering prebiopsy mpMRI and defining those in whom biopsy may be omitted when
the mpMRI is negative.
Patient summary:
This systematic review examined if multiparametric magnetic reso-
nance imaging (MRI) scan can be used to reliably predict the absence of prostate cancer in
patients suspected of having prostate cancer, thereby avoiding a prostate biopsy. The
results suggest that whilst it is a promising tool, it is not accurate enough to replace
prostate biopsy in such patients, mainly because its accuracy is variable and influenced by
the prostate cancer risk. However, its performance can be enhanced if there were more
accurate ways of determining the risk of having prostate cancer. When such tools are
available, it should be possible to use an MRI scan to avoid biopsy in patients at a low risk of
prostate cancer.
#
2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.
Prostate biopsy
Risk stratification
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