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Editorial

Referring to the article published on pp. 23

30 of this issue

The

PROMIS

of Magnetic Resonance Imaging Cost Effectiveness

in Prostate Cancer Diagnosis?

Jochen Walz

*

Department of Urology, Institut Paoli-Calmettes Cancer Centre, Marseille, France

Since multiparametric magnetic resonance imaging

(mpMRI) was introduced into diagnostic pathways for

prostate cancer, there has been ongoing controversy about

the cost effectiveness of such pathways. mpMRI is currently

recommended before a repeat biopsy, but some authors also

favor use of mpMRI before the first biopsy

[1,2]

. mpMRI is

without doubt a rather expensive test that is time-intensive

and resource-consuming. These issues stand in the context

of the epidemiological characteristics of prostate cancer, the

most frequent male cancer in the Western world, with

further increases in incidence expected. Together these

features represent a major challenge for health care systems

if mpMRI is to be used systematically before any biopsy. For

these reasons, systematic use of mpMRI in the diagnosis of

prostate cancer needs to be carefully evaluated.

In this issue of

European Urology

, Faria and colleagues

[3]

describe a cost-effectiveness analysis based on PROMIS

[4] ,

a trial among

[1_TD$DIFF]

576 biopsy-naïve men in which 1.5-T mpMRI

was followed by a 5-mm transperineal template mapping

biopsy and then a standard transrectal 12-core biopsy to

evaluate the diagnostic accuracy of mpMRI before first

biopsy. From their analysis, Faria and colleagues conclude

that the most cost-effective use of mpMRI is scenario M7

222, involving mpMRI before a first biopsy followed by up to

two mpMRI

targeted biopsies if negative, which has

sensitivity of 0.95 (95% confidence interval [CI] 0.92

0.98), a testing cost of £807 per man (95% CI £777

£833),

and an incremental cost-effectiveness ratio (ICER) of £7076

per quality-adjusted life year (QALY) gained relative to an

approach using systematic biopsy first.

There are several points that should be addressed. First,

when looking at the 383 different possible scenarios, the

combination of a systematic transrectal biopsy followed by

an mpMRI-guided biopsy (scenario T7 222) resulted in

sensitivity of 0.91 (95% CI 0.86

0.94) and a testing cost of

£709 per man (95% CI £688

£730), which is significantly

less expensive but not significantly less effective. When

leaving out other outcomes such as ICER/QALY, which

largely depend on arbitrary thresholds and assumptions,

this provides evidence that the current recommendation of

a systematic biopsy first, followed by an mpMRI-guided

approach might be a valid option. Second, the data are based

on the PROMIS trial, which has several limitations. For the

current analysis the most relevant limitation of PROMIS is

that no MRI-guided or MRI-targeted biopsies were per-

formed. All the results in PROMIS are presented assuming

that targeted biopsies would achieve similar diagnostic

accuracy as the transperineal template biopsy

[4]

. It is clear

that this assumption is not realistic. The true performance

of the mpMRI pathway will be lower

[5]

. The PROMIS

investigators recognized that they cannot accurately assess

the clinical utility of an MRI-targeted biopsy approach, but

such an approach is the cornerstone of an MRI pathway and

a pivotal aspect for realistic cost-effectiveness analysis. The

sensitivity analysis in the current publication demonstrates

that if the sensitivity of MRI is reduced (which will occur in

real life), the strategy of systematic biopsy first followed by

an mpMRI-guided approach second (scenario T7 222)

becomes the most cost effective. This observation needs

to be taken into account when drawing conclusions from

the analysis. Third, there are several flaws associated with

the use of mpMRI that depend largely on quality and quality

assurance. The mpMRI scans in PROMIS were carried out

after centralized and repeated training of radiologists and

E U R O P E A N U R O L O GY 7 3 ( 2 0 18 ) 3 1 3 2

ava ilable at

www.sciencedirect.com

journal homepage:

www.eu ropeanurology.com

DOI of original article:

http://dx.doi.org/10.1016/j.eururo.2017.08.018

.

* Department of Urology, Institut Paoli-Calmettes Cancer Centre, 232 Boulevard Ste. Marguerite, 13009 Marseille, France. Tel. +33 49 1223532; Fax:

+33 49 1223613.

E-mail address:

walzj@ipc.unicancer.fr

.

http://dx.doi.org/10.1016/j.eururo.2017.09.015

0302-2838/© 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.