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The panel did not reach consensus on whether repeat
standard biopsy and/or targeted biopsy should be
performed on men with MRI changes. Some felt that a
man eligible for treatment at the start of the surveillance
period (eg, small-volume Gleason 3 + 4 disease) would
not require additional biopsy confirmation for a minor
radiologic change. Although some expressed a wish for
biopsy verification of suspected MRI-depicted disease
progression, it was recognised that patients and clinicians
may reasonably opt for treatment without further biopsy.
4. Discussion
4.1. Summary of results
The PRECISE checklist outlines key information that
researchers should report in a study of a cohort of men
having an MRI on active surveillance for PCa. The PRECISE
case report form is designed for clinical radiologists to
report an individual MRI at baseline or follow-up. Use of the
case report form will ensure that appropriate data are
collected to inform cohort reporting.
The number of statements scored with agreement and
consensus reduced from pre-meeting scoring to scoring at
the meeting. The purpose of the face-to-face element of a
formal consensus meeting is to allow detailed discussion and
interaction of the panellists to fully explore a topic. This can
reduce or increase consensus. The reduced number of
statements with agreed consensus showed that many
challenging topics were discussed in an area in which data
are emerging.
4.2. Clinical and research implications
MRI is being used more frequently in men on active
surveillance to assess for clinically significant disease
missed at initial biopsy or to reduce the need for repeat
biopsy There are data to suggest that stability on MRI
can predict Gleason score stability .
The use of MRI in men on active surveillance varies
between countries and health systems, with a lower use of
MRI outside of academic centres . Some centres exclude
men with visible lesions on MRI from an active surveillance
programme to reduce the likelihood of unfavourable
pathology . It is known that some small lesions on
prostate MRI can be pathologically benign or of a low-grade
tumour only . However, others recognise that it is likely
that long established active surveillance series would no
doubt have included men who would have had visible
lesions on MRI had it been available at that time, and
treatment of all men with MRI-visible disease is likely to
lead to significant overtreatment. Data have shown that
men with a visible lesion (positive MRI) are more likely to
receive treatment than men with a negative MRI. The extent
to which clinical decisions may have been influenced by this
factor is not easy to determine because there are few studies
in which clinicians were blinded to MRI results.
We hope that use of the PRECISE checklist will allow the
natural history of MRI changes inmen on active surveillance
to become clearer, allowing appropriate significance
thresholds for radiologic disease to be set both at baseline
and during surveillance. The correlation of radiologic
findings with PSA and histologic data, and treatment-free
survival will also be of great value. The use of the PRECISE
recommendations to analyse large data sets such as those
from the Movember Global Action Project on Active
Surveillance would allow rapid assessment and
refinement of the recommendations based on data from
multiple centres worldwide.
4.3. Limitations
The greatest limitation of these recommendations is the
lack of published data on which they are based. The
intention of these recommendations is that they will allow
robust data collection in those areas deemed most
important by expert opinion, so that further iterations will
be based on those data. The areas most in need of research
are the optimal way of measuring lesion size to allow
repeatability over time and both the change in size and
absolute size that should prompt clinical action. Although
there is a possibility of bias in the groups selected for the
consensus meeting, only a small number of centres declined
the invitation to participate.
5. Conclusions
The PRECISE recommendations were developed to facilitate
robust data collection and thus assess the natural history of
MRI findings in men on active surveillance. If widely used,
the data derived will facilitate the determination of
thresholds that identify radiologically significant disease
and important radiologic changes on MRI. It is likely that
initial validation work will lead to refinement of the
recommendations in due course.
Author contributions: Caroline M. Moore 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: Moore, Valdagni, Schoots, Allen, Kirkham.
Acquisition of data: Giganti, Schoots, Albertsen, Allen, Bangma, Briganti,
Carroll, Haider, Kasivisvanathan, Kirkham, Klotz, Ouzzane, Padhani,
Panebianco, Pinto, Puech, Ranniko, Renard-Penna, Touijer, Turkbey, van
Poppel, Valdagni, Walz, Moore.
Analysis and interpretation of data: Giganti, Moore.
Drafting of the manuscript: Moore.
Critical revision of the manuscript for important intellectual content:
Giganti, Schoots, Albertsen, Allen, Bangma, Briganti, Carroll, Haider,
Kasivisvanathan, Kirkham, Klotz, Ouzzane, Padhani, Panebianco, Pinto,
Puech, Ranniko, Renard-Penna, Touijer, Turkbey, van Poppel, Valdagni,
Walz, Moore.
Statistical analysis: Giganti, Kasivisvanathan, Moore.
Obtaining funding: Moore, Valdagni.
Administrative, technical, or material support: Kasivisvanathan.
Supervision: Moore.
Other (specify): None.
Financial disclosures: Caroline M. Moore certifies that all conflicts of
interest, including specific financial interests and relationships and
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