Open Journal of Urology, 2011, 1, 67-71
doi:10.4236/oju.2011.14014 Published Online November 2011 (http://www.SciRP.org/journal/oju)
Copyright © 2011 SciRes. OJU
The Performance of Abnormal Digital Rectal
Examination for the Detection of Prostate
Cancer at Stratified Prostate Specific Antigen Levels
Guven Aslan1*, Bora Irer1, Sertac Cimen1, Yigit Goktay2,
Ilhan Celebi1, Burcin Tuna3, Kutsal Yorukoglu3
1Dokuz Eylul Uni vers i t y School of Medici n e De pa rtment of Urology, Izmir, Turkey
2Dokuz Eylul Uni vers i t y School of Medici n e De pa rtment of Radiology , Izmir, Turkey
3Dokuz Eylul Universit y Sch ool of Me dici n e Depa rt ment of Pathology, Izmir, Turkey
Received April 27, 2011; revise May 30, 2011; accepted June 10, 2011
Objective: Our aim was to determine the performance of abnormal digital rectal examination (DRE) in
prostate cancer detection at different PSA levels. Methods: A total of 1612 patients having abnormal DRE
and/or elevated PSA whom underwent TRUS guided prostate biopsies were included in the study. Any pal-
pable induration or nodularity was accepted as abnormal DRE findings. Pathologic features of biopsy speci-
mens were compared within groups according to DRE findings and serum PSA level groups of 2.5 - 4, 4 - 10
and >10 ng/ml. Results: Abnormal DRE was detected in 339 patients; of whom 48.7% were determined to
have cancer. Cancer detection rates of patients having abnormal DRE were found to be 20%, 31.5% and 68%
at PSA ranges 2.5 - 4, 4 - 10 and >10 ng/ml, respectively. Significantly higher grade cancers were detected
by abnormal DRE at each PSA group. The positive and negative predictive values of abnormal DRE accord-
ing to groups of PSA 2.5 - 4, 4 - 10 and >10 ng/ml were 20% and 84.1%, 31.5% and 80.6%, 68% and 66.6%,
respectively. Conclusion: At each PSA group DRE resulted in detecting significantly more cancers with
Gleason score > 7. Although predictive value of abnormal DRE diminishes with concomitantly decreasing
PSA levels, significance of DRE in the diagnosis of prostate cancer cannot be ignored.
Keywords: Prostate, Prostate Cancer, Prostate Specific Antigen, Digital Rectal Examination,
Prostate cancer is one of the major causes of cancer-re-
lated mortality in the world . Early diagnosis is of
paramount importance given its considerable role in de-
clining the cancer specific deaths. The diagnostic invest-
tigation, which primarily aims at identifying the prostate
cancer patients in the potentially curable stages is mainly
based on two consecutive steps: digital rectal examina-
tion (DRE) and serum prostate specific antigen level
(PSA) [2,3]. The optimal usages of these diagnostic tools
which bring up the indication of prostate biopsy are sub-
jected to controversies . These controversies are tar-
geted on the predictivity of abnormal DRE findings (in-
duration, asymmetry or irregularity) in the screening of
prostate cancer regardless of the serum PSA level and the
cut-off levels of serum PSA level for cancer detection
regardless of the DRE findings . Because these tests
are complementary, we evaluated the predictive value
and diagnostic performance of DRE in prostate cancer
detection at different serum PSA level groups (PSA 2.5 -
4, 4 - 10 and > 10 ng/ml).
2. Patient and Methods
The database consisting of the demographic features,
clinical and laboratory data of the patients who under-
went transrectal ultrasonography (TRUS) guided prostate
needle biopsy was examined. The primary admission
purpose was regular check up in 1112 (68.9%) of pa-
tients and infravesical obstruction in 500 (31.1%) for the
remainder. Patients with a history of acute urinary reten-
G. ASLAN ET AL.
tion and or any urethral instrumentation within 3 months
were excluded from the study. No patient with acute uri-
nary retention is included in the study. All subjects un-
derwent urine analysis and culture to differentiate urinary
infection. Those suggestive of urinary infection or
known prostatitis were excluded from the study. Be-
tween January 2006 and December 2009, 1612 eligible
patients with complete data for the analysis were in-
cluded in the study. When a patient underwent re-biopsy,
final pathology was recorded in the data evaluation of
patients. Regardless of the admission purpose, digital
rectal examination and PSA testing were both performed
in all patients over 50 years old age and they underwent
TRUS guided prostate needle biopsy with the indication
of either abnormal DRE findings or elevated serum PSA
level (PSA ≥ 2.5 ng/mL). The digital rectal examinations
were performed by the staff urologists. Any palpable
induration, irregularity or nodularity were accepted as
“abnormal DRE findings” and therefore consisted an in-
dication for biopsy. In the serum PSA measurement Tan-
dem-E immunoenzymatic assay was used. Transrectal
ultrasonography guided prostate biopsy was performed
by the same author, using a 7 MHz. transrectal trans-
ducer and an automatic biopsy gun fitted with an 18
gauge Tru-Cut needle and 10-core biopsies were obtained
as described in the literature .
Patients were grouped according to the findings of
DRE as normal or abnormal. Thereafter patients were
divided into three groups according to serum PSA levels;
2.5 ng/ml - 4 ng/ml, 4 ng/ml - 10 ng/ml, and > 10 ng/ml.
According to pathology results of biopsy specimens
which show the presence or absence of cancer, positive
and negative predictive values, sensitivity and specificity
of abnormal digital rectal examination in detecting pros-
tate cancer were determined within PSA level groups.
The areas under the receiver operator characteristic
(ROC) area under the curve (AUC) as well as sensitivity
and specificity were calculated to assess the diagnostic
performances in PCa detection of the various assays.
Any differences were judged as statistically significant at
p < 0.05 using Student’s t-test for continuous parametric
variables, and the chi-square test for categorical vari-
All subjects were Caucasian. Mean age of the patients
was 67 ± 7.8 years and the mean serum PSA level of the
patients was 19.4 ± 43.5 ng/ml. Overall cancer was de-
tected in 449 (27.8%) of the men who underwent biopsy.
Pathologic features of subjects with abnormal or normal
DRE findings according to the PSA levels are shown in
Table 1. Abnormal DRE findings were detected in 339
patients; of whom 48.7% were determined to have cancer.
Higher serum PSA levels were significantly associated
with increased cancer detection rate. Significantly higher
grade cancers were detected by abnormal DRE at each
PSA level group (Table 1).
Table 1. Demographic and pathologic features of patients stratified by DRE findings and PSA range.
PSA 2.5 - 4 ng/ml PS A 4 - 10 ng/ml PSA > 10 ng/ml All
DRE (–) DRE (+) p DRE (–)DRE (+)p DRE (–)DRE (+)p DRE (–) DRE (+)p
N 196 50 756 114 321 175 1273 339
Mean Age (yrs) 63.1 ± 6.9 66.5 ± 8.5 66.0 ± 7.169.5 ± 6.90.01 68.2 ± 7.971.9 ± 8.00.02 66.1 ± 7.4 70.3 ± 7.80.04
No pts with cancer 31 10 146 36 0.003107 119 <0.001 284 165 <0.001
Gleason Sum (n)
6 20 6 93 13 47 19 160 38
7 9 1 41 18 35 48 85 67
8 - 2 5 2 10 8 15 12
9 2 1 7 3 14 42 23 46
10 - - - - 1 2 1 2
rate %) 15.8 20 19.3 31.6 33.3 68 22.3 48.7
DRE (+): abnormal digital rectal examination; DRE (–): normal digital rectal examination.
Copyright © 2011 SciRes. OJU
G. ASLAN ET AL.
TRUS guided prostate biopsy was performed in 50 pa-
tients with abnormal digital rectal examination and a
serum PSA level of less than 4 ng/ml. Prostate cancer
was determined in only 10 (20%) of these patients.
Seven of 10 patients underwent radical prostatectomy,
and their pathologic analysis was consistent with pT2 in
6 and pT3a in one with surgical margin negativity at all.
The positive and negative predictive values of abnor-
mal digital rectal examination according to the serum
PSA level were 20% and 84.1% for PSA 2.5 ng/ml - 4
ng/ml, 31.5% and 80.6% for PSA 4 ng/ml - 10 ng/ml and
68% and 66.6% for PSA > 10 ng/ml , respectively (Ta-
ble 2). Sensitivity and specificity results for each PSA
group are given in Table 2. As might be expected sensi-
tivity of DRE were low in psa 2.5 ng/ml - 10 ng/ml range.
The sensitivity significantly increased at PSA over 10
We then analyzed the receiver operating characteristic
(ROC) curves in patients with different PSA values to
evaluate the diagnostic performance of PSA and DRE for
the detection of prostate cancer (Figure 1). Area Under
Curve (AUC) were 0.524 and 0.535 for abnormal DRE
and PSA in PSA range of 2.5 ng/ml - 4 ng/ml, 0.542 and
0.546 in range of 4 ng/ml - 10 ng/ml and 0.660 and 0.614
in PSA range of >10 ng/ml, respectively. ROC curve
performance for DRE was similar to those for PSA alone
for the discrimination between prostate cancer and be-
nign disease in each PSA range (Figure 1).
Table 2. Statistical performance of abnormal DRE in the detection of prostate cancer stratified by PSA ranges.
PSA 2.5 - 4 ng/ml PSA 4 - 10 ng/ml PSA > 10 ng/ml All
DRE (+) DRE (+) DRE (+) DRE (+)
PPV NPV 20 31.5 68 48.6
Sensitivity 84.1 80.6 66.6 77.6
Specificity 24.1 19.7 52.6 36.7
AUC 80.4 88.6 79.2 85
0.524 0.542 0.660 0.609
Figure 1. ROC curve performance of DRE and PSA in each PSA range
Copyright © 2011 SciRes. OJU
G. ASLAN ET AL.
Digital rectal examination and serum PSA testing are
both essential in the diagnostic work-up of prostate can-
cer [2,3,6]. These consecutive steps are carried out be-
fore making the decision of a TRUS guided prostate bi-
opsy. Because TRUS guided prostate biopsy is an un-
pleasant experience for the patient and relatively invasive
diagnostic procedure, the circumstances under which it is
warranted have to be determined precisely. This obliga-
tion which aims at declining the number of unnecessary
biopsies, gives rise to debates pertaining to the indica-
tions of this procedure. On one hand, predictive value of
abnormal or suspicious digital rectal examination in
prostate cancer regardless of the serum PSA level is tried
to be pointed out, and on the other hand the most appro-
priate serum PSA threshold levels are tried to be deter-
mined [7-10]. Today at low PSA levels in daily practice
it is not possible to draw one straight-forward conclusion
in using DRE or a low PSA cut-off value.
Several authors report that DRE is not a good screen-
ing tool and therefore the value of digital rectal examina-
tion DRE as a screening test for prostate cancer remains
controversial currently [11,12]. A recent study have
shown that after 8 years; men with a benign prostate bi-
opsy and an initially abnormal DRE were not at higher
risk for the detection of significant prostate cancer in the
following years compared to same group of men with
initially normal DRE . Due to its poor performance,
especially at low PSA levels, DRE has been omitted
from the screening trials [12,14]. Despite the limitations
of DRE as a screening test, there remain a significant
proportion of prostate cancers that are diagnosed by DRE
alone. Furthermore, we and other recent studies have
shown that DRE is still important in diagnosing clini-
cally important prostate cancer and continues to provide
important prognostic information . Regardless of
PSA an abnormal DRE was consistent with cancer in
almost 50% of our patients.
In the present study the PPV of a suspicious DRE, in
conjunction with an elevated PSA level, to detect PC was
48.7% compared to 22.3% for men with a normal DRE.
At each PSA level group the chance of having cancer at
biopsy was higher in men with a suspicious DRE com-
pared to men with a normal DRE. Although both predic-
tive values decreased in low PSA, the chance for finding
prostate cancer remained higher in men with abnormal
DRE in all level groups. Overall, 20% positive predictive
value of abnormal DRE for finding cancer on prostate
biopsy with a PSA level between 2.5 and 4.0 ng/mL is
lower, but still substantial, compared with the value of
approximately 31.6% to 68% for a PSA level greater
than 4.0 ng/mL. Our overall PPV values are very close to
those at ERSPC study at which PSA cutoff was 3 ng/ml
In our study we have determined that approximately
50% of the cancers detected at a PSA level less than 4.0
ng/mL had aggressive features (Gleason grade 7 or
greater with Gleason 4 to 5 components). At each PSA
level group DRE resulted in detecting significantly more
PCs with Gleason score > 7. Our results have shown that
there is considerable additional value of an abnormal
DRE in the selection of more hazardous prostate cancers.
Thus we may speculate DRE may be useful in more se-
lective screening procedures to determine high risk pros-
Catalona et al., in their multicenter study comprising
6630 patients, determined the overall positive predictive
value of the abnormal DRE as 21%, and they calculated
the positive predictive value of suspicious digital rectal
examination as 10%, 40.8%, and 69.1% in the patient
groups with serum PSA level of <4 ng/ml, 4.1 - 9.9, and
> 10 ng/ml, respectively . The stratification model of
Catalona et al. which is very close to ours revealed that
the positive predictive value of the abnormal digital rec-
tal examination increases in parallel with increasing PSA
ranges . In our study the positive predictive values of
the digital rectal examination was found to be 20%,
31,6% and 68% in the PSA ranges of 2.5 - 4, 4 - 10 and
>10 ng/ml, respectively. The positive predictive value
determined in our study is higher than the Catalona et
al.’s report for low PSA range, but the difference be-
tween the prostate needle biopsy protocols should be
considered . While Catalona et a l. performed quadrant
biopsies, 10-core biopsy was chosen as a standard pro-
tocol in our study and probably higher core number in-
creased the cancer detection rate.
Although interobserver variability and lower predict-
tive values of DRE at low PSA are main diasvantages,
we are yet unable to strictly recommend “DRE-inde-
pendent lowest PSA threshold value” for waiving biopsy
in spite of suspicious digital rectal examination findings.
The significance of DRE in the diagnosis of prostate
cancer cannot be ignored, when as many as 15.2% of
men with low PSA (PSA ≤ 4 ng/ml) had prostate cancer
was considered . Moreover, an abnormal DRE was
associated with a significantly increased risk of high-
grade disease, indicating that it provides useful addi-
tional prognostic information.
Considering the efficacy of both methods in detecting
prostate cancer, in its diagnostic work-up DRE and PSA
should be used in conjunction. Although the positive
predictive value of abnormal DRE diminishes with con-
comitantly decreasing PSA levels, it will be worthwhile
to know that “there are” cancer cases detected by DRE in
low PSA ranges. This reality justifies the performance of
Copyright © 2011 SciRes. OJU
G. ASLAN ET AL.
a precise digital rectal examination even in low serum
 S. H. Landis, T. Murray, S. Bolden and P. A. Wingo, “Can-
cer Statistics,” CA: A Cancer Journal for Clinicians, Vol.
48, No. 1, 1998, pp. 6-29. doi:10.3322/canjclin.48.1.6
 S. J. Jacobsen, S. K. Katusic, E. J. Bergstralh, et al., “In-
cidence of Prostate Cancer Diagnosis in the Eras before
and after Prostate-Specific Antigen Testing,” The Journal
of the American Medical Association, Vol. 274, No. 18,
1995, pp. 1445-1449. doi:10.1001/jama.274.18.1445
 D. S. Smith, P. A. Humphrey and W. J. Catalona, “The
Early Detection of Prostate Carcinoma with Prostate Spe-
cific Antigen: The Washington University Experience,”
Cancer, Vol. 80, No. 9, 1997, pp. 1852-1856.
 G. F. Carvalhal, D. S. Smith, D. E. Mager, C. Ramos and
W. J. Catalona, “Digital Rectal Examination for detecting
Prostate Cancer at Prostate Specific Antigen Levels of 4
ng/ml or Less,” Journal of Urology, Vol. 161, No. 3,
1999, pp. 835-839. doi:10.1016/S0022-5347(01)61785-3
 J. L. Gore, S. F. Shariat, B. J. Miles, D. Kadmon, N. Ji-
ang, T. M. Wheeler and K. M. Slawin, “Optimal Combi-
nations of Systemic Sextant and Laterally Directed Biop-
sies for the Detection of Prostate Cancer,” Journal of
Urology, Vol. 165, No. 5, 2001, pp. 1554-1559.
 K. Mistry and G. Cable, “Meta-Analysis of Prostate-Spe-
cific Antigen and Digital Rectal Examination as Screen-
ing Tests for Prostate Carcinoma,” The Journal of the
American Board of Family Medicine, Vol. 16, 2003, No.
2, pp. 95-101. doi:10.3122/jabfm.16.2.95
 R. O. Roberts, E. J. Bergstralh, M. M. Lieber and S. J.
Jacobsen, “Digital Rectal Examination and Prostate-Spe-
cific Antigen Abnormalities at the Time of Prostate Bi-
opsy and Biopsy Outcomes, 1980 to 1997,” Urology, Vol.
56, No. 5, 2000, pp. 817-822.
 T. Yamamoto, K. Ito, M. Ohi, et al., “Diagnostic Signifi-
cance of Digital Rectal Examination and Transrectal Ul-
trasonography in Men with Prostate-Specific Antigen
Levels of 4 ng/ml or Less,” Urology, Vol. 58, No. 6, 2001,
pp. 994-998. doi:10.1016/S0090-4295(01)01409-1
 J. E. Fowler, S. A. Bigler, P. B. Farabaugh and S. S. Wil-
son, “Prostate Cancer Detection in Black and White Men
with Abnormal Digital Rectal Examination and Prostate
Specific Antigen Less than 4 ng/ml,” Journal of Urology,
Vol. 164, No. 6, 2000, pp. 1961-1963.
 W. J. Catalona, J. P. Richie, F. R. Ahmann, et al., “Com-
parison of Digital Rectal Examination and Serum Prostate
Specific Antigen in the Early Detection of Prostate Can-
cer: Results of a Multicenter Clinical Trial of 6630 Men,”
Journal of Urology, Vol. 151, No. 5, 1994, pp. 1283-1290.
 C. Gosselaar, M. J. Roobol, S. Roemeling, T. H. van der
Kwast and F. H. Schröder, “Screening for Prostate Can-
cer at Low PSA Range: The Impact of Digital Rectal
Examination on Tumor Incidence and Tumor Character-
istics,” The Prostate, Vol. 67, No. 2, 2007, pp. 154-161.
 F. H. Schröder, M. Roobol-Bouts, A. N. Vis, T. van der
Kwast and R. Kranse, “Prostate-Specific Antigen-Based
Early Detection of Prostate Cancer-Validation of Screen-
ing without Rectal Examination,” Urology, Vol. 57, No. 1,
2001, pp. 83-90.
 C. Gosselaar, M. J. Roobol, R. van den Bergh, T. Wolters
and F. H. Schroder, “Digital Rectal Examination and the
Diagnosis of Prostate Cancer—A Study Based on 8 Years
and Three Screenings within the European Randomized
Study of Screening for Prostate Cancer (ERSPC), Rot-
terdam,” European Urology, Vol. 55, No. 1, 2009, pp.
 P. M. Beemsterboer, R. Kranse, H. J. de Koning, J. D.
Habbema and F. H. Schroder, “Changing Role of 3 Screen-
ing Modalities in the European Randomized Study of
Screening for Prostate Cancer (Rotterdam),” International
Journal of Cancer, Vol. 84, No. 4, 1999, pp. 437-441.
 O. T. Okotie, A. K. Roehl, M. Han, S. Loeb, S. N. Gashti
and W. J. Catalona, “Characteristics of Prostate Cancer
Detected by Digital Rectal Examination Only,” Urology,
Vol. 70, No. 6, 2007, pp. 1117-1120.
 C. Gosselaar, M. J. Roobol, S. Roemeling and F. H.
Schroder, “The Role of the Digital Rectal examination in
Subsequent Screening Visits in the European Random-
ized Study of Screening for Prostate Cancer (ERSPC),
Rotterdam,” European Urology, Vol. 54, No. 3, 2008, pp.
 M. I. Thompson, D. K. Pauler, P. J. Goodman, et al.,
“Prevalance of prostate cancer among men with a pros-
tate-specific antigen level ≤ 4 ng per milliliter,” The New
England Journal of Medicine, Vol. 350, No. 22, 2004, pp.
Copyright © 2011 SciRes. OJU