under systematic quality control of MRI scanners and
images by an independent clinical research organization
[4] .According to a personal communication with the
PROMIS investigators, several centers applied to be study
centers to PROMIS, but were excluded as they were unable
to provide the quality, despite the fact that radiologists had
expert training and expert counseling for setting up MRI
scanners. In view of these facts, systematic use of MRI as a
triage test before a first biopsy will fail if comparable high-
quality standards and systematic long-term quality assur-
ance protocols are not implemented. Moreover, again
because of quality issues, scans that were considered of
insufficient quality needed to be repeated
[4]. It is unknown
how often this was necessary in the PROMIS trial, but from
personal experience, at least a third of MRI scans performed
in the community setting are of poor or insufficient quality
(eg, no scoring system, no high
b
values, no apparent
diffusion coefficient maps, dynamic contrast-enhanced
images with poor temporal resolution)
[6] .Current cost-
effectiveness analyses do not take this issue into account,
but doing so will change the results. Fourth, mpMRI is
resource-consuming but has a low degree of invasiveness.
There is a non-negligible risk that mpMRI will be used not
only in patients with a clear indication for prostate biopsy
(eg, based on prostate-specific antigen results or a suspi-
cious digital rectal examination) but also deliberately as a
low threshold check-up test independent of any solid biopsy
indication. The same concern might result in frequently
repeated MRIs (ie, yearly) for follow-up, just in case of
changes in the prostate. Such policies would literally
explode the use of MRI, and with it, associated costs. Fifth,
the current analysis was conducted under a number of
assumptions to calculate the results. The analysis by Faria
and colleagues is based on the UK health care system, so the
results are only applicable to this system and UK
circumstances. Extrapolation of these results to other
health care systems is not warranted or could only be done
under great caution.
In summary: it is clear that mpMRI is about to
revolutionize the management of and thinking about
prostate cancer, and any image-guided diagnosis is urgently
needed and most welcome. However, before mpMRI can be
used in and recommended for a general population, further
realistic cost-effectiveness analyses for each health care
system are necessary. In addition, the indispensable infra-
structure needs to be set up, with clear regulations to be
established by health care systems to direct indications,
quality, and standards. Without these prerequisites, the
dilemma of prostate cancer diagnosis will not be solved, and
limited and precious resources will be wasted.
Conflicts of interest:
The author receives fees for lectures and consulting
from Hitachi, Supersonic, and ANNA/C-TRUS.
References
[1] Mottet N, Bellmunt J, Briers E, et al. Guidelines on prostate cancer.
European Association of Urology.
http://uroweb.org/guideline/ prostate-cancer.
[2]
Porpiglia F, Manfredi M, Mele F, et al. Diagnostic pathway with multiparametric magnetic resonance imaging versus standard path- way: results from a randomized prospective study in biopsy-naïve patients with suspected prostate cancer. Eur Urol 2017;72:282 – 8.
[3]
Faria R, Soares M, Spackman E, et al. Optimising the diagnosis of prostate cancer in the era of multiparametric magnetic resonance imaging: a cost-effectiveness analysis based on the Prostate MR Imaging Study (PROMIS). Eur Urol 2018;73:23 – 30.
[4]
Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accu- racy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating con fi rmatory study. Lancet 2017; 389:815 – 22.
[5]
Branger N, Maubon T, Traumann M, et al. Is negative multiparametric magnetic resonance imaging really able to exclude signi fi cant pros- tate cancer? The real-life experience. BJU Int 2017;119:449 – 55.
[6]
Renard-Penna R, Rouvière O, Puech P, et al. Current practice and access to prostate MR imaging in France. Diagn Interv Imaging 2016;97:1125 – 9.
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