EURURO Vol. 72 No. 6

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Based on our cohort, for men after previous biopsy, our
RM provided the best sPC discrimination. For biopsy-naı¨ve
men, adding mpMRI to the original ERSPC-RC3 or clinical
parameters (our RM) exceeded the discrimination of all
tools alone. Therefore, both ERSPC-RC3 + mpMRI and the
RM could be used in the future.
Findings of our study should be interpreted in context of
some limitations. First, we prospectively used PI-RADSv1.0,
while PI-RADSv2.0 has recently become the favored ap-
proach, since the time period for data accrual predominantly
was before publication of PI-RADSv2.0. Since 2015, we
routinely use PI-RADSv2.0 and PI-RADSv1.0, because data are
still not fully decisive as to the advantage of either over the
other. In a recent meta-analysis, higher pooled sensitivity
(0.95) for PI-RADSv2.0 compared with that of PI-RADSv1.0
(0.88) but comparable pooled specificity (0.73 vs 0.75) were
detected On the contrary, Auer et al[5_TD$DIFF] found significantly
larger discrimination for PI-RADSv1.0 (0.96) versus PI-
RADSv2.0 (0.90)[13_TD$DIFF] All our mpMRI results were read by
expert readers, but we did not assess for interobserver
variability even among specialized radiologists, as men-
tioned by Rosenkrantz et al . These points have to be
contemplated when validating our RMs externally. Further-
more, we took FTB from PI-RADS 2 lesions to gain
maximum security. However, FTB of PI-RADS = 2 lesions is
of no relevant benefit. Therefore, we have stopped to target
PI-RADS = 2 foci in 2016.
Our sPC definition of GS 3 + 4 is debatable. However, to
compare our results with ERSPC-RC3/4, GS 3 + 4 was most
appropriate. We acknowledge that the comparison to
ERSPC-RCs is not perfect, since we did not include clinical
T staging in our sPC definition .
Lastly, the time and cost consumption of mpMRI and
fusion biopsy compared with relatively inexpensive clinical
parameters have to be weighed against the benefit for sPC
detection. However, cost effectiveness of mpMRI prior to
biopsy has been suggested previously .
5. Conclusions
Novel RMs incorporating clinical parameters and MRI
assessment according to PI-RADS are superior to ERSPC-
RCs and PI-RADS alone to discriminate between the
presence and absence of sPC. Benefits of the RMs exceed
those of original ERSPC-RCs and PI-RADS alone in the
selection of patients who should receive biopsy.
Author contributions: Jan Philipp Radtke had full access to all the data in
the study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Hadaschik, Radtke, Bonekamp, Hohenfellner.
Acquisition of data: Radtke, Kesch, Celik, Distler, Wieczorek.
Analysis and interpretation of data: Radtke, Bonekamp, Hadaschik,
Roethke, Schlemmer.
Drafting of the manuscript: Radtke, Freitag.
Critical revision of themanuscript for important intellectual content: Kesch, Alt,
Roethke, Schlemmer, Duensing, Roth, Teber, Hohenfellner, Hadaschik.
Statistical analysis: Wiesenfarth, Radtke, Stock, Bonekamp.
Obtaining funding: None.
Administrative, technical, or material support: Roethke, Schlemmer,
Duensing, Roth, Wieczorek.
Supervision: Hadaschik, Hohenfellner, Schlemmer, Bonekamp.
Other: None.
Financial disclosures: Jan Philipp Radtke certifies that all conflicts of
interest, including specific financial interests and relationships and
affiliations relevant to the subject matter or materials discussed in the
manuscript (eg, employment/affiliation, grants or funding, consultancies,
honoraria, stock ownership or options, expert testimony, royalties, or
patents filed, received, or pending), are the following: B. Hadaschik is
grateful for funding from the German Research Foundation. This source had
not any input whatsoever into this article. D. Bonekamp is speaker for
Profound Medical Inc. The other authors of the manuscript have nothing to
disclose.
Funding/Support and role of the sponsor: None.
Appendix A. data
Supplementary data associated with this article can be
found, in the online version, at
.
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