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Urological Oncology
2010 BJU INTERNATIONAL
ENDORECTAL MRI TO PREDICT pT3 PROSTATE CANCER
BRAJTBORD
ET AL.
BJUI
Endorectal magnetic resonance imaging has
limited clinical ability to preoperatively predict
pT3 prostate cancer
BJU INTERNATIONAL
Jonathan S. Brajtbord, Hugh J. Lavery, Fatima Nabizada-Pace,
Prathibha Senaratne and David B. Samadi
Department of Urology, The Mount Sinai Medical Center, New York, NY, USA
Accepted for publication 25 May 2010
Study Type – Diagnostic (non consecutive
case series)
Level of Evidence 3b
academic settings. A sub-group of high-risk
patients was also analyzed for erMRI
accuracy.
RESULTS
OBJECTIVES
To assess the clinical value of preoperative
knowledge of the presence of extracapsular
extension (ECE) or seminal vesicle invasion
(SVI) in the planning for prostatectomy.
MATERIALS AND METHODS
An institutional database of 1161 roboticassisted laparoscopic prostatectomies (RALP)
performed by a single surgeon (D.B.S.) was
queried for those who underwent endorectal
coil magnetic resonance imaging (erMRI)
before robotic-assisted laparoscopic
prostatectomy. erMRI reports were
dichotomized into positive or negative and
compared with the final histopathology. The
erMRIs performed at academic centres were
compared with those performed in non-
INTRODUCTION
Accurate preoperative staging of prostate
cancer can aid in treatment selection as well
as operative planning because it may alter the
surgical approach to neurovascular bundle
preservation. Preoperative knowledge of
locally advanced disease may lead the
surgeon to perform a wide resection of the
neurovascular bundle on the affected side(s)
[1]. However, the current clinical staging
techniques of digital rectal examination, PSA
and transrectal ultrasound-guided biopsy are
often inaccurate, with as many as 30% being
incorrectly staged [2,3]. One proposed way of
improving staging is preoperative imaging,
©
The 179 patients who underwent erMRI had
significantly worse disease compared to the
982 patients without imaging. Of the 110
patients with histopathologically organconfined disease, 81 (74%) were correctly
diagnosed as such on erMRI, whereas 29
(26%) were felt to have cT3 disease and
constituted false-positives. Among the 69
patients with pT3 disease, erMRI correctly
predicted 30 (43%), whereas 39 (57%) were
incorrectly considered organ-confined. The
overall sensitivity and specificity for
diagnosing pT3 disease was 43% and 73%.
When stratified by pT3a and pT3b, the
sensitivity and specificity of erMRI to
accurately diagnose ECE is 33% and 81%,
respectively. In evaluating SVI, erMRI has a
sensitivity and specificity of 33% and 89%,
respectively. The positive predictive value of
and one of the most promising of such
technologies is endorectal coil magnetic
resonance imaging (erMRI) [4–11].
The accuracy of erMRI in staging prostate
cancer is variable, with some studies
suggesting a sensitivity and specificity for
detecting T3 disease >90% [5,10]. These
results have led to the conclusion that the
erMRI adds incremental value to clinical
parameters and nomograms for the detection
of T3 disease [12]. The clinical applicability of
such studies is questionable, however,
because those that demonstrate the best
performance characteristics of erMRI have
been performed on all patients who presented
erMRI to assess for ECE and SVI is 50% in
both, with a negative predictive value of 61%
and 63%, respectively. erMRIs performed
at academic centres compared to nonacademic locations demonstrated similar
rates of sensitivity at 67% vs 77% and
specificity at 39% vs 54%, respectively
(P = 0.33).
CONCLUSIONS
In the setting of the present study, which
was designed to be more reflective of current
practice patterns in the USA, erMRI has
limited clinical value in preoperatively
detecting ECE and SVI. The accuracy of
detecting T3 disease did not improve in
academic centres or in high-risk patients.
KEYWORDS
prostate cancer, neoplasm staging,
endorectal magnetic resonance imaging
(erMRI), radical prostatectomy
for prostatectomy. As such, most of those
patients had organ-confined disease.
Additionally, all previous studies have used
the reports of academic radiologists
specialized in either MRI or the genitourinary
system. Such specialists are rare in nonacademic centres, where the majority of the
staging of prostate cancer is performed.
We evaluated the accuracy of erMRI in
predicting the presence of extracapsular
extension (ECE) and seminal vesicle invasion
(SVI) in patients with clinically localized
prostate cancer. We reviewed our database of
over 1100 robotic-assisted laparoscopic
prostatectomies (RALP) for those who had a
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JOURNAL COMPILATION
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2 0 1 0 B J U I N T E R N A T I O N A L | doi:10.1111/j.1464-410X.2010.09599.x
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B R A J T B O R D ET AL.
preoperative MRI. An important difference
between the present study and those that
preceded it is that the MRIs were ordered on
selected higher-risk patients, and performed
both at private imaging centres, as well as
academic institutions. This is more reflective
of the current practice environment in the
USA than previous study designs.
MATERIALS AND METHODS
A prospectively maintained, institutionalreview board approved database comprised of
all patients undergoing RALP by a single
surgeon (D.B.S.) is maintained by research
staff at the Mount Sinai Medical Center.
Patients undergoing RALP before August
2009 formed the base population for the
current analyses (n = 1420). Data on 259
patients were incomplete and were excluded
from the analyses; subsequent to these
exclusions, completed data were available for
1161 patients. The database was queried for
those who underwent erMRI before RALP,
making this study a retrospective review of a
prospective database. Some 179 (15%)
patients underwent erMRI and comprised the
study population. The majority of patients
were selected for erMRI based upon clinical
parameters worrisome for locally advanced
disease: clinically palpable disease, high-risk
PSA score, and a large volume of high Gleason
score. However, some patients underwent
erMRI at the discretion of referring urologists
in the absence of clinical high-risk disease. No
patients were excluded from consideration of
RALP on the basis of erMRI findings.
erMRI reports were dichotomized into
positive or negative for both ECE and SVI
because equivocal reports were considered
positive. The presence of either ECE or SVI on
erMRI constituted a ‘locally advanced’
tumour. The erMRI result was compared with
the final histopathological stage as reported
by our institutional genitourinary
pathologists, which was considered as the
gold standard for calculation of sensitivity
and specificity. This analysis was repeated
where equivocal reports were classified as
negative and compared with the final
histopathology. The tumour was staged
according to the 2002 American Joint
Commission on Cancer TNM staging system
and graded according to the Gleason grading
system [13]. Tumour at the inked resection
margin was considered a positive surgical
margin (PSM). PSMs were dichotomized into
2
TABLE 1 Preoperative characteristics
Parameter
Number of patients
Age (years), mean
PSA (ng/mL), mean
PSA density
Clinical T1c
Clinical T2
Clinical T3
Biopsy, Gleason sum
6
7 (3 + 4)
7 (4 + 3)
8–10
Perineural invasion on biopsy
Number of positive cores, mean
Percent positive cores, mean
Highest tumour % in single core, mean
erMRI
179
59.3
6.6
0.15
105 (66)
50 (32)
2 (1.3)
No erMRI
982
59.2
6.0
0.12
730 (88)
83 (10)
2 (0.24)
P
61 (34)
60 (34)
22 (12)
35 (20)
52 (29)
4.87
39%
53%
596 (61)
250 (25)
85 (8.7)
51 (5.2)
133 (14)
2.80
23%
26%
<0.001
0.91
0.056
0.001
<0.001
<0.001
<0.001
<0.001
<0.001
erMRI, endorectal coil magnetic resonance imaging.
‘focal’ or ‘extensive’ if the length of the
margin was <2 mm or >2 mm, respectively.
To assess the impact of preoperative risk
factors on the performance characteristics of
erMRI, we performed a sub-analysis of the
data restricted to preoperatively high-risk
patients. This was defined as those patients
with a preoperative PSA ≥20 or biopsy
Gleason score ≥8. To evaluate the effect of
expert radiologist consultation on outcomes,
we compared the erMRIs performed at
academic centres with those performed at
non-academic imaging centres. Because our
institution performed the highest number of
the academic MRIs, we also compared the
results of our own institution with those of
other academic hospital centres to validate
the performance of our radiologists.
Results were analyzed with SPSS, version 17.0
(SPSS inc. Chicago, IL, USA). Chi-squared and
ANOVA were used to compare categorical
and continuous variables, respectively. All
statistical analyses were two-tailed with P <
0.05 considered statistically significant.
RESULTS
On preoperative evaluation, the 179 patients
who underwent erMRI had significantly worse
disease compared to the 982 patients without
imaging (Table 1). Patients in the erMRI
cohort had higher PSA, Gleason scores, rates
of palpable nodules and more positive biopsy
cores. Similarly, histopathological tumour
characteristics were worse among patients
who underwent preoperative erMRI (Table 2).
On final histopathology, Gleason 6, 7 and
8–10 were present in 13%, 69% and 16% of
patients undergoing erMRI, compared to
32%, 64% and 5% of patients without erMRI
(P < 0.001). Locally-advanced (pT3 and pT4)
cancers were found in 39% of patients in the
erMRI cohort compared to 15% among those
without an erMRI (P < 0.001).
Of the 110 patients with histopathologically
organ-confined disease, 81 (74%) were
correctly diagnosed as such on erMRI,
whereas 29 (26%) were considered to have
cT3 disease and constituted false-positives.
Among the 69 patients with pT3 disease,
erMRI correctly predicted 30 (43%), whereas
39 (57%) were incorrectly considered to be
organ-confined (Fig. 1). This results in an
accuracy of 64%, with an overall sensitivity
and specificity for diagnosing pT3 disease of
43% and 73%, respectively. The positive
predictive value of erMRI is 50% with a
negative predictive value of 67% (Table 3).
When locally-advanced tumors were
stratified by ECE and SVI, the sensitivity and
specificity of erMRI to accurately diagnose
ECE is 33% and 81%, respectively. The
sensitivity and specificity of erMRI to
diagnose positive SVI was 33% and 89%,
respectively.
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JOURNAL COMPILATION
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2010 THE AUTHORS
2010 BJU INTERNATIONAL
ENDORECTAL MRI TO PREDICT pT3 PROSTATE CANCER
No erMRI
P
8 (4.5)
6 (3.4)
95 (53)
127 (13)
26 (2.6)
678 (69)
<0.001
42 (23)
27 (15)
1 (0.56)
110 (11)
30 (3.1)
8 (0.81)
<0.001
24 (13)
91 (51)
33 (18)
29 (16)
46.44
66 (37)
26 (15)
3 (1.7)
313 (32)
503 (51)
129 (13)
47 (4.8)
33.59
141 (14)
32 (3.3)
2 (0.20)
<0.001
<0.001
<0.001
0.028
23 (13)
19 (11)
96 (9.7)
64 (6.5)
0.21
0.05
FIG. 1.
Endorectal coil magnetic
resonance imaging (erMRI)
results stratified by pathological
stage.
TABLE 2
Pathological characteristics
When the criteria used to define a positive
erMRI were changed so that equivocal reports
(n = 14) were considered negative, the
specificity increased at the expense of
sensitivity. The specificity in detecting ECE and
SVI rose to 93% and 97%, respectively,
whereas the sensitivity dropped to 19% and
10%.
erMRIs performed at academic centres
(n = 107) compared to non-academic
locations (n = 72) demonstrated similar
sensitivity and specificity rates: 67% vs 77%
and 39% vs 54%, respectively (P = 0.33). No
differences existed between our institution
(n = 77) and other academic centres (n = 30)
with respect to the ability of erMRI to
accurately predict T3 disease (P = 0.85).
90
80
70
60
50
40
30
20
10
0
DISCUSSION
Organ confined
on erMRI
locally advanced
on erMRI
pT2
pT3
TABLE 3 Performance characteristics of endorectal coil magnetic resonance imaging
Parameter
Sensitivity
Specificity
Positive predictive value
Negative predictive value
Accuracy
Overall for T3 disease
43%
73%
50%
68%
62%
ECE
33%
81%
50%
61%
63%
Sensitivity: [(true positive/(true positive + false negative)] × 100
Specificity: [(true negative/(true negative + false positive)] × 100
Positive predictive value: [(true positive/(true positive + false positive)] × 100
Negative predictive value: [(true negative/(true negative + false negative)] × 100
Accuracy: [(true Positive + true negative)/patient population] × 100
ECE, extracapsular extension; SVI, seminal vesicle invasion.
©
A total of 101 (8.7%) patients were identified
as high risk (PSA ≥20 or biopsy Gleason score
≥8), 36 of whom underwent erMRI, whereas
65 did not. The sensitivity and specificity for
the erMRI to accurately diagnose pT3 disease
in this cohort was 57% and 38%, respectively,
which was not statistically different than
those of the entire erMRI cohort (Table 4).
erMRI
# of Patients
Pathological staging
pT2:
pT2a
pT2b
pT2c
pT3:
pT3a
pT3b
pT4:
Pathology, Gleason sum
6
7 (3 + 4)
7 (4 + 3)
8–10
% Tumour volume, mean
Extracapsular extension
Seminal vesicle invasion
Lymph node positive
Positive surgical margin
Focal (≤2 mm)
Extensive (>2 mm)
erMRI
SVI
33%
89%
50%
63%
61%
Variable results have been reported for the
utility of erMRI in staging prostate cancer. In
the prediction of ECE, studies have reported a
sensitivity and specificity in the range from
13–95% and 49–97% [4–11]. A similar
variability is present in the detection of SVI,
with sensitivity in the range 23–80% and
specificity in the range 81–99% specificity
[4–11,14]. The results obtained in the present
study are at the low end of these ranges, with
a sensitivity of 43% and specificity of 74% for
predicting such locally advanced disease.
When the erMRI suggests the presence of SVI
or ECE, the probability that the patient having
locally advanced disease (the positive
predictive value) is 50%, equivalent to a coin
toss. This demonstrates that erMRI has a
limited ability to preoperatively predict SVI
and ECE, and a positive test does not reliably
indicate the presence of extraprostatic
disease. As such, it is difficult to make clinical
decisions based on erMRI results.
Why are the results of our series different
from other series, which demonstrate a
sensitivity and specificity of more than 90%
[5,10]? Three aspects of the present study
design differ from those that preceded it. The
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B R A J T B O R D ET AL.
first is the selection of the patient population
studied and thus the proportion of patients
with high-risk disease. The second is related
to the radiologist who interpreted the erMRI,
and the third is the definition of a positive
erMRI.
Most previous studies have been performed
on all patients undergoing prostatectomy
[4,5,11,12,15–18]. Because erMRI may be
more accurate in assessing patients with
organ-confined disease [17] and most
patients in the modern era have organconfined disease [19], this may increase the
apparent accuracy of the erMRI. By contrast,
we did not standardize the patients who
underwent erMRI. Rather the decision to
perform erMRI was made by either the
operative surgeon (D.B.S.) or the referring
urologist based on clinical parameters that
were worrisome for locally advanced disease.
As a result of these selection criteria, patients
in the erMRI group had almost twice the rate
of pT3/4 (39%) than previous studies, which
typically have a locally-advanced rate of
approximately 20% [15,17].
Given these selection criteria for erMRI and
the subsequent high rate of locally advanced
disease, it could also be expected that our
series may demonstrate better performance
characteristics, namely an improved
sensitivity for detecting T3 disease. However,
with a sensitivity and specificity of 43% and
73%, respectively, this was not the case. Even
when high-risk patients who underwent an
erMRI were selected from our series (PSA ≥20
or biopsy Gleason score ≥8, n = 36), the
performance characteristics of the erMRI
were unchanged from our overall series.
Sensitivity to detect ECE on erMRI was slightly
improved to 55% from 33%, and the positive
predictive value improved from 50% to 73%,
although these were not statistically
significant. The findings obtained in the
present study suggest that, even among highrisk patients, erMRI remains inaccurate.
A second difference in the design of the
present study design relates to the
radiologists who perform the exam and
interpret the results. All previous studies
assessing the staging accuracy of erMRI were
performed by genitourinary specialists in
major academic institutions with a high
volume of erMRIs. Indeed, almost all recent
literature on the topic has come from a single
institution that performs high volumes
of erMRI and often MR spectroscopy
4
TABLE 4 Performance characteristics of endorectal coil magnetic resonance imaging in high-risk
patients (PSA >20 or biopsy Gleason score >8)
Parameter
Sensitivity
Specificity
Positive predictive value
Negative predictive value
Accuracy
Overall for T3 disease
57%
38%
76%
80%
53%
ECE
55%
42%
73%
25%
49%
SVI
25%
70%
40%
54%
50%
ECE, extracapsular extension; SVI, seminal vesicle invasion.
[4,12,15–18]. It has been suggested that such
specialization is required to accurately read
an erMRI. In a study designed to compare the
accuracy of genitourinary MR between
specialists and general radiologists, a
significant improvement in the accuracy of
erMRI to properly diagnose ECE and SVI was
present only in the specialist group of
radiologists [15].
The patients in the present study underwent
erMRI at a mix of both academic and nonacademic institutions, with radiologists
of varying levels of experience and
specialization. To assess the impact of
radiological specialization on the accuracy of
erMRI in predicting locally-advanced disease,
those patients who had erMRIs performed at
academic centres were recompared with
those performed in community hospitals
and local imaging centres. Academic and
community settings demonstrated similar
sensitivity and specificity: 67% vs 77%
sensitivity and 39% vs 54% specificity at
the two settings, respectively (P = 0.33).
Additionally, we found no difference in the
accuracy of erMRIs performed in our
institution compared to those conducted in
other academic centres. We consider that the
mix of academic and community imaging
centres is reflective of current referral
patterns in the community, where academic
centres and specialized genitourinary
radiologists are not always available.
Consequently, this makes the results obtained
in the present study more clinically relevant
and applicable.
Recent studies have defined a positive erMRI
through the assignment of a score on a scale
of 1–5 to determine the radiologist’s
confidence in the presence or absence of ECE
and SVI [4,12,18]. This scoring system is
designed to identify the definitive presence or
absence of T3 disease at the same time as
permitting and capturing a variety of
equivocal reports. On the basis of this scoring
system, receiver-operating characteristic
curves are created to reflect the accuracy of
the erMRI in properly staging the cancer.
However, the clinical utility of this method is
questionable. Although it is appreciated that
radiographic interpretation has inherent
uncertainties, as clinicians, we seek
dichotomous, ‘yes or no’ answers. For this
reason, the results of the present study were
dichotomized, with the 14 equivocal reports
classified as positive. In a screening tool, it is
advantageous to maximize the sensitivity to
identify a greater amount of patients with the
condition. As such, our classification of
equivocal erMRIs as positive was considered
to be appropriate. To assess the impact of our
dichotomization scheme, the data were
reanalyzed with equivocal reports classified as
negative. As expected, by raising the threshold
for a positive test, the sensitivity dropped to
19% as the specificity increased to 93%.
The costs of the erMRI, in terms of both
financial expense and patient discomfort, are
rarely discussed in the literature. Often,
patients need to restrict their diets to clear
liquids on the day before the procedure and
perform one or more enemas to clear their
rectal vault of fecal material. The MRI
machine can make patients feel
claustrophobic, sometimes necessitating the
use of a sedative. Patients must forgo at least
part of a day’s work for travel to the imaging
centre and completion of the procedure.
Finally, a balloon-tipped probe is inserted into
the patient’s rectum, inflated with 50–70 mL
of air and rotated when the patient remains
completely still for 30 min. Our institution
charges $2500 for an erMRI, of which
$823.32 is reimbursed by Medicare [20].
Clearly, if the erMRI is of great diagnostic
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JOURNAL COMPILATION
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ENDORECTAL MRI TO PREDICT pT3 PROSTATE CANCER
value and would significantly alter
preoperative planning, the argument can be
made that these costs are worthwhile for a
more accurate preoperative diagnosis.
However, given the low sensitivity of the
present study, along with a 50% positive
predictive value, it is difficult to justify the
patient’s discomfort or the cost of the test.
The present study has several limitations, in
addition to the potential areas of criticism
addressed above. Although the number of
patients undergoing erMRI in the present
study was larger than in many previous
reports [5,9,17], other studies are larger
[4,12,18] and the present study is a
retrospective analysis. We did not standardize
the patients who underwent erMRI; by
definition, this results in selection bias.
However, this is more reflective of the current
practice environment, and a good diagnostic
test should perform well, regardless of the
patients upon whom it was performed.
Additionally, we were unable to obtain the
training and experience profiles of the
radiologists who conducted the erMRIs; it is
possible that some of the community imaging
centres may employ fellowship-trained
radiologists.
positive erMRI does not reliably indicate the
presence of extraprostatic disease. The
accuracy of detecting T3 disease did not
improve when restricted to high-risk patients
or to erMRIs performed at academic centres.
This supports the current recommendations
against the widespread preoperative use of
erMRI.
10
CONFLICT OF INTEREST
None declared.
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©
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Correspondence: David Samadi, Division of
Robotics and Minimally Invasive Surgery,
Department of Urology, The Mount Sinai
Medical Center, 625 Madison Avenue, Suite
230, New York, NY 10022, USA.
e-mail: [email protected]
Abbreviations: ECE, extracapsular extension;
erMRI, endorectal coil magnetic resonance
imaging; PSM, positive surgical margin;
RALP, robotic-assisted laparoscopic
prostatectomy; SVI, seminal vesicle
invasion.
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