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Our results seemed to contribute to confirming the role
of mpMRI in avoiding unnecessary biopsies. In arm A MRI+,
only one case of csPCa (3.8%) was diagnosed. This finding
could suggest that prostate biopsy in a biopsy-naı¨ve man
with suspicion of PCa but negative mpMRI results could be
avoided in the near future. Nevertheless, strict follow-up of
these patients is recommended until more robust data are
available.
The main strength of this study was its prospective RCT
design, in accordance with good clinical practice guidelines.
The results were reported according to the START recom-
mendations. Moreover, the accuracy of histopathologic
evaluation was guaranteed by the involvement of a single
expert uropathologist. The mpMRI was performed accord-
ing to standardized protocols, and its results were reported
using the PI-RADS classification. This RCT was based on the
creation of a new diagnostic pathway, which was possible
owing to collaboration among the experts of three radiology
centers and a urology division qualified in innovative PCa
diagnosis and treatment.
A limitation of this approach could be the lack of
reproducibility in other centers (ie, lack of skilled staff or
technologies). The reproducibility of a single-center RCT is
not comparable with results of a multicenter study. It is
possible that the adoption of PI-RADS v.2.0 or the use of
a 3-T MRI would have resulted in even better diagnostic
performance of mpMRI, although a recent systematic
review did not support this hypothesis . Further limita-
tions include the lack of correlation with specimen
pathology and the heterogeneity of the mpMRI equipment.
Finally, as previously stated, some comparisons between
the subgroups might have been less reliable owing to the
small sample size.
5. Conclusions
In biopsy-naı¨ve men with suspected PCa, PSA levels
15 ng/ml, and negative DRE results, prebiopsy mpMRI
allowed us to detect greater numbers of PCa and csPCa
lesions compared with 12-core SB. Moreover, biopsy
samples resulted in more information in terms of CCL
and CCI. Our results supported that mpMRI could be
considered prior to a first prostate biopsy. Larger sample
sizes could confirm these data.
Author contributions: Francesco Porpiglia 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: Porpiglia.
Acquisition of data: Manfredi, Mele, Cossu.
Analysis and interpretation of data: Manfredi, Mele, De Luca.
Drafting of the manuscript: Manfredi, Fiori, De Luca.
Critical revision of the manuscript for important intellectual content: Bollito,
Veltri, Cirillo, Regge, Faletti, Fiori, De Luca.
Statistical analysis: Passera.
Obtaining funding: None.
Administrative, technical, or material support: None.
Supervision: Porpiglia.
Other (specify): None.
Financial disclosures: Francesco Porpiglia 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 testimo-
ny, royalties, or patents filed, received, or pending), are the following:
None.
Funding/Support and role of the sponsor: None.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at
.
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