EURURO Vol. 71 No. 4

3.5.

Reporting of the biopsy at entry to active surveillance

There was agreement and consensus on the use of the

Gleason score, but uncertainty and no consensus on the use

of maximum cancer core length (MCCL) and maximum

number and proportion of cores. Panel members felt that

many cohorts of men on active surveillance will not have

had an MRI-targeted biopsy at study entry and that the

number or proportion of positive cores would be strongly

influenced by the strategy used to perform the biopsies

(standard or targeted to MRI lesions). Reporting the

maximum number of positive cores is a helpful indicator

in a standard random biopsy, but it is less helpful when

oversampling is intended during a targeted biopsy of a

Table 2 – The PRECISE checklist

Item Section of paper

Description

Title

The study should be identified as reporting results from MRI in men on active surveillance, either to identify men as suitable for

AS or as a tool for repeat assessment on AS

Introduction

The introduction should include a clear statement of the research question or study aim (eg, correlation of pathologic outcomes

with radiologic change, assessment of radiologic change on repeat MRI) and background information such as the take up of AS in

men deemed suitable

Study design

and population

The setting, location, and recruitment period and study design (prospective/retrospective) should be reported. It should be made

clear (and citation given) if the report is an update of a previously published cohort

The inclusion and exclusion criteria with the maximum Gleason score, maximum PSA, and the name, version, and citation of an

established AS protocol or risk classification system (where relevant) should be reported

The requirement for confirmatory biopsy, frequency of PSA testing, and the indication and frequency for biopsy, MRI, and any

additional test (eg, genomic classifiers)

Indications for a switch to active treatment should be specified

Conduct of

the MRI

Whether or not the MRI conduct met the minimum criteria set by the European Society of Uroradiology and the American College

of Radiologists

[4]

or other stated guidelines

The field strength and the specific coils used should be stated including a brief description of the sequences

The in-plane resolution and slice thickness of the T2 W images should be stated; the image sets analysed for DWI including the

highest b-value acquired and whether the highest b-value was extrapolated or not; the temporal resolution for DCE images

Reporting of

the MRI

The number of radiologists reporting scans in the study should be stated

The availability (or not) of clinical information and previous MRI images to the reporting radiologist should be stated

When more than one radiologist reports a scan, it should be stated whether this is done separately or in consensus. When done

separately it should be stated how a summary value was derived (eg, mean absolute values or mean change between scans per

reporter)

The reporting method used (eg, prose vs diagrammatic report, name and version of scoring system) should be given

Conduct of the

biopsy

The anatomic approach (transrectal/transperineal) and method of targeting MRI lesions; the use of separate pots for targeted and

systematic cores (if applicable)

The time interval between MRI and biopsy (median and range)

Whether systematic cores are taken in all, and the intended number of systematic cores per prostate and targeted cores per

lesion; whether systematic biopsy was performed blind to MRI findings. The criteria for choosing a lesion to be targeted, whether

the biopsy operator had direct access to the MR images. Where software assistance was used for registration of MRI and

ultrasound images, the manufacturer and model should be stated

Patient

characteristics

The age range, baseline PSA, and MRI-derived prostate volume, distribution of Gleason score, and risk categories across the group

and the MCCL. The number of men taking drugs that would affect the hormonal environment of the prostate (eg, 5

-reductase

inhibitors, testosterone) should be recorded

A flowchart of participants showing numbers of men eligible, offered and enrolled in the study, with those who continue on AS

and the treatment status of those who are not on AS

Individual patient

baseline MRI

report

The baseline MRI report should contain the prostate volume measured on T2 W imaging and a likelihood of clinically significant

cancer on a scale of 1–5 for the whole prostate and for each lesion. The likelihood of extraprostatic extension and seminal vesicle

involvement should be reported on a 1–5 scale. The index lesion size should be reported using volume (by planimetry or derived

from three diameters) or measurement of 1 or 2 diameters

Follow-up MRI

In addition to features reported at baseline, any subsequent MRI report should include the following:

A score on a 1–5 scale for the likelihood of significant change, along with a description of the change that has given rise to the

score (eg, change in size, change in conspicuity on one or more sequences)

Any change in likelihood of significant cancer (1–5 scale)

An increase in suspicion due to extension into seminal vesicles or a suspicious lymph node or bone lesion

Absolute values of lesion size at baseline and each subsequent scan

The appearance of any new lesion

Any lesion becoming nonvisible

10 Reporting of

follow-up biopsy

findings

Separate reporting of systematic and targeted cores with a MCCL and Gleason grouping per patient irrespective of whether this

was derived from targeted or systematic cores; mean/median number of cores per prostate and per lesion; mean/median number

of lesions per patient where targeted cores were taken

11 Statistical analysis The effect of interreader variability; whether any effect depends on the size of the baseline lesion; whether outliers (very large or

very small lesions) were excluded; how the disappearance of a lesion is handled in the statistical analysis. Where there is

adequate power to do so, univariate and multivariate analysis should be used to assess the added value of a reporting statement

to baseline clinical data; the odds ratio for a single and a combination of unfavourable factors should be given

12 Discussion

The clinical applicability of the findings should be discussed, along with the correlation of the observed MRI changes with

traditional tools to measure disease progression (DRE, PSA kinetics, biopsy findings)

AS = active surveillance; DCE = dynamic contrast-enhanced; DRE = digital rectal examination; DWI = diffusion-weighted imaging; MCCL = maximum cancer

core length; MRI = magnetic resonance imaging; PSA = prostate-specific antigen; T2W = T2-weighted.

E U R O P E A N U R O L O G Y 7 1 ( 2 0 1 7 ) 6 4 8 – 6 5 5

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