EuropeanUrology European Urology 45 (2004) 450–456

Morbidity of Prostatic Biopsy for Different BiopsyStrategies: IsThere a Relation to Core Number andSampling Region?Roger Paula,*, Stefan Scholera, Heiner van Randenborgha, Hubert Kublera,Michael Alschibajaa, Raymonde Buschb, Rudolf Hartunga

aDepartment of Urology, Technische Universitat Munich, Klinikum rechts der Isar, Ismaninger Str. 22, 81675 Munich, GermanybInstitute of Medical Statistics and Epidemiology, Technische Universitat Munich, Klinikum rechts der Isar,

Ismaninger Str. 22, 81675 Munich, Germany

Accepted 16 December 2003

Published online 11 January 2004

AbstractObjectives: The standard sextant prostatic biopsy is a safe procedure associated with low morbidity. Newer biopsyprotocols suggest an increase in core numbers or sampling in distinct areas. In this respect we investigated themorbidity of different biopsy regimens.Methods: Morbidity was assessed using self-administered questionnaires 1 week and 1 month after biopsy in aprospective randomized trial of 405 men with three different biopsy protocols. We compared a sextant biopsyregimen to a 10-core biopsy strategy, as well as patients with a re-biopsy including t-zone sampling. We investigatedpain during and after biopsy, gross hematuria, rectal bleeding, hematospermia, fever and chills.Results: There is a trend towards a more painful biopsy and higher rate of side effects if the number of core samplesis increased, this difference did not reach statistical significance. There was no increase in severity of side effects.Regarding the rate and severity of side effects of biopsy strategies to different areas of the prostate we could not finda difference. About 95% of patients would accept a repeat biopsy based on their experience on first biopsy.Conclusions: Morbidity of transrectal prostatic biopsy is low and increasing the number of cores correlates with aminor and statistically not significant increase in the rate of side effects. Transrectal sextant prostatic biopsy andextensive biopsy protocols are generally well tolerated and widely accepted from patients.# 2004 Elsevier B.V. All rights reserved.

Keywords: Prostate cancer; Prostatic biopsy; Morbidity

1. Introduction

Prostatic biopsy is a necessary and the only possibleprocedure to confirm the diagnosis of prostate cancer.Transrectal ultrasound guided biopsy has become stan-dard in urology [1], but the details of prostatic biopsiesare discussed controversly and no ‘‘standard’’ has beendefined regarding the number of biopsy cores and theregions of the prostate which should be biopsied. Sys-

tematic sextant biopsy of the prostate is widely used [2],however newer strategies for prostatic biopsies empha-size the increase in number of core biopsies [3–5] and/orbiopsy sampling of distinct areas of the prostate [6,7].

Reports have shown that the standard sextant biopsyscheme is a procedure with rare major complicationsbut common minor morbidities [8]. It is howeverunclear if increasing the number of biopsy cores orsampling of distinct areas in the prostate will increasemorbidity. Therefore we investigated three differentbiopsy regimens with different core numbers and areasof sampling to establish the effect on morbidity in aprospective randomized trial.

* Corresponding author. Tel. þ49-89-4140-2507;

Fax: þ49-89-4140-2585.

E-mail address: R.Paul@lrz.tu-muenchen.de (R. Paul).

0302-2838/$ – see front matter # 2004 Elsevier B.V. All rights reserved.

doi:10.1016/j.eururo.2003.12.007

2. Materials andmethods

Between May 2000 and April 2001 405 patients, scheduled forprostatic biopsy, were randomized to either a transrectal ultrasoundguided standard sextant biopsy (6 þ X) or a 10-core biopsy strategy(10 þ X) in case of first time biopsy. The standard sextant biopsy iscomposed of three cores of each lateral prostatic lobe from thebasal, the central and the apical area. Biopsies are directed towardsthe most lateral aspect of the peripheral zone (p-zone). Additionalbiopsies were allowed to suspicious areas on digital rectal exam-ination and/or sonographic hypoechoic areas outside the sextantarea. For the 10-core biopsy we performed a standard sextantbiopsy as described and additionally 2 cores were sampled oneach lateral lobe medially from the sextant series (median biopsies)from the p-zone. Again additional directed biopsies to suspiciousareas were allowed. Patients who were scheduled for a repeatbiopsy received a standard sextant biopsy as described and addi-tionally 2 cores were sampled from the ventral part of the transi-tional zone (t-zone) on each side of the prostate, also additionaldirected biopsies to suspicious areas were allowed.

All patients received local anesthesia (230 mg lidocain jelly,transrectally) and a perioperative antibiotic prophylaxis with cipro-floxacine (500 mg/d starting the evening before biopsy for a total of5 days). We used an ATL HDI 1000 multiplanar probe 5–9 MHzand the Topnotch automatic 18 Ga core biopsy system (Micro-vasive, Boston Scientific).

Morbidity was assessed by a self-administered questionnaire 1week and 1 month after biopsy and patients were asked to look forsymptoms asked by the questionnaire. We evaluated pain duringand after biopsy, gross hematuria, blood in stool, hematospermia,fever (>38 8C) and chills. Length and intensity of side effects werenoted. Patients were asked if they would agree to repeat prostaticbiopsy if necessary as well. Approval of the Institutional ReviewBoard/Independent Ethics Committee (IRB/IEC) was obtainedbefore.

2.1. Statistical analysisStatistical analysis was performed using SPSS V10 software.

Descriptive and comparative statistics were carried out usingthe Mann–Whitney U-test and Kruskal–Wallis test for contin-uous variables and the Pearson–w2-test or Fisher Exact test fornominal variables. Statistical significance was accepted at 5%( p < 0:05). Highly statistically significance was assumed with ap-value <0.01 and a statistical trend for missing significance upto 20%.

3. Results

3.1. Patient cohort405 patients were recruited and 100 patients were

randomized to either group (6 þ X or 10 þ X cores),205 patients were scheduled for re-biopsy. Mean agewas 65.1 years (see Table 1). For the standard sextantbiopsy group (6 þ X) and for the 10-core biopsy group(10 þ X) there was no difference on statistical analysisfor PSA ( p ¼ 0:13), %-free PSA ( p ¼ 0:46), prostaticsize ( p ¼ 0:53), transitional zone size ( p ¼ 0:24),digital rectal examination (DRE, p ¼ 0:3) and trans-rectal ultrasound (TRUS, p ¼ 0:3). The re-biopsy group

showed statistical significant differences regarding ahigher median PSA ( p < 0:001). In this group the meanage was slightly higher, prostatic size and adenoma sizeelevated, but this differences were not statistical sig-nificant (see Table 1).

Mean number of core biopsies was 6.4 (6–8) for thesextant group, 10.3 (10–13) for the 10-core group and10.3 (10–18) for the re-biopsy group. Prostate cancerwas found in 32.0% (n ¼ 32) in the 6 þ X group, 40.0%(n ¼ 40) in the 10 þ X group and 30.2% (n ¼ 62) in there-biopsy group.

Return rate of questionnaire 1 week after biopsywas 83.2% and 1 month after biopsy 71.9%. 89.9% ofpatients returned at least one of the two questionnaires.Return rate of questionnaires for different biopsy stra-tegies ranged from 66.8 to 95.0% (see Fig. 1).

3.2. Pain during and after biopsyPatients were asked 1 week and 1 month after

prostatic biopsy by self-administered questionnairefor their subjective experience of pain during and after

Table1Patients characteristics for standard sextant biopsy group (6 þ X), 10-core

biopsy group (10 þ X) and re-biopsy group

Parameter Total 6 þ X 10 þ X Re-biopsy

n 405 100 100 205

Mean age (years) 65.1 64.4 64.2 65.8

Mean PSA (ng/ml) 11.0 8.1 15.3 10.1

Mean %f PSA 14.8 14.3 14.7 15.0

DRE suspicious 36.7% 41.1% 35.7% 35.2%

TRUS suspicious 47.4% 53.8% 45.9% 45.1%

Mean prost. size (ml) 64.2 62.9 55.7 69.3

Mean size adenoma (ml) 39.7 39.6 33.1 43.2

Mean no. core biopsies 9.3 6.4 10.3 10.3

Range no. core biopsies 6–18 6–8 10–13 10–18

88,0

95,0

82,484,088,0

66,8

0

10

20

30

40

50

60

70

80

90

100

6+X 10+X rebiopsy

Q. 1 week post bpx

Q. 1 month post bpx.

Fig. 1. Return rate of self-administered questionnaire 1 week and 1 month

after prostatic biopsy for sextant biopsy (6 þ X), 10-core biopsy (10 þ X)

and re-biopsy group.

R. Paul et al. / European Urology 45 (2004) 450–456 451

biopsy. Nearly 2/3 of the patients experienced no oronly mild pain during and after biopsy for all biopsystrategies (Fig. 2). There was no statistical difference ifpatients were asked 1 week or 1 month after biopsy,although there was a slight increase towards more painat 1 month after biopsy (see Table 2). Duration of painafter biopsy, evaluated 1 week after biopsy, was notedon average for 1 day for all three biopsy strategies(0.95–1.2 days), again there was no statistical differ-ence between the different biopsy techniques. Inter-estingly, pain after biopsy, if evaluated 1 month afterbiopsy was reported on average for 2 days for all threebiopsy strategies (2.1–2.7 days), again without nostatistical difference between different strategies(Fig. 3).

Significant pain during micturition after biopsy wasnoted in 1.2% in the 6 þ X and 6.5% and 6.0% in the10 þ X and re-biopsy group respectively, this pain

usually lasted less than a day (0.37–0.68 days).Although there is a trend towards increased pain ifmore biopsy cores are taken, there was no statisticalsignificance again. Pain during bowel movement afterbiopsy was noted between 3.2% and 4.1% of patientsfor an average time of half a day, without any differ-ences between different biopsy strategies.

3.3. MorbidityMorbidity was also assessed by a self-administered

questionnaire 1 week and 1 month after biopsy (Figs. 4and 5). No differences were observed between thesetwo questionnaires; therefore results are given only forthe questionnaires 1 month after biopsy. Gross hema-turia was common between 57.6% (6 þ X), 72.0%(10 þ X) and 70.4% (re-biopsy). This difference wasstatistically significant ( p ¼ 0:05). The majority ofgross hematuria was self-limiting without treatment,

28,2%

40,0%

24,7%

7,1%

22,3%

44,7%

14,9%

18,1%

21,6%

43,9%

24,6%

9,9%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

6+X 10+X Rebiopsy

severemoderatemildno

Fig. 2. Pain during biopsy stratified for different biopsy strategies.

54,1%

31,8%

8,2%5,9%

38,0%

35,9%

7,6%

42,1%

39,2%

4,1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

6+X 10+X Rebiopsy

severemoderatemildno

14,6%18,5%

Fig. 3. Pain after biopsy stratified for different biopsy strategies evaluated

1 week after prostate biopsy by a self-administered questionnaire.

Table 2Pain during and after prostatic biopsy for different biopsy strategies

Biopsy strategy Pain quality 6 þ X (%) 10 þ X (%) Re-biopsy (%)

Pain during biopsy No 28.2 22.3 21.6

Mild 40.0 44.7 43.9

Moderate 24.7 14.9 24.6

Severe 7.1 18.1 9.9

Pain after biopsy (1 week after biopsy) No 54.1 38.0 42.1

Mild 31.8 35.9 39.2

Moderate 8.2 18.5 14.6

Severe 5.9 7.6 4.1

Pain after biopsy (1 month after biopsy) No 40.7 34.5 41.3

Mild 35.8 47.1 39.9

Moderate 16 12.6 11.6

Severe 7.5 5.8 7.2

Pain during micturition No/mild 98.8 93.5 94.0

Moderate/severe 1.2 6.5 6.0

Pain during bowel movement No/mild 96.5 96.8 95.9

Moderate/severe 3.5 3.2 4.1

452 R. Paul et al. / European Urology 45 (2004) 450–456

no patient of the 6 þ X group, and only 1 patient of the10 þ X and re-biopsy-group was seen by an officeurologist for hematuria, no actions were taken. Theduration of hematuria was 1.9 days for the sextantgroup and 2.4 days for the 10 þ X and 2.9 days for there-biopsy group in mean, statistical significance wasfound only between the sextant and re-biopsygroup. Rectal bleeding after biopsy was not as commonas gross hematuria. 18.3% of the 6 þ X group, 29.3%of the 10 þ X group and 25.3% of the re-biopsy groupexperienced blood in stool; these differences did notreach statistical significance. Rectal bleeding wasexperienced on average only for half a day. Onlyone patient of the re-biopsy group was treated for rectalbleeding by inserting a temporary tamponade, nosurgical intervention was necessary. Fever (2.2–3.5%)and chills (1.2–3.3%) were uncommon in either biopsygroup and no statistical differences were found. 15.2%reported of no ejaculation after prostatic biopsy. In theremaining patients hematospermia was very common,as expected. 65.3% of the 6 þ X, 75.0% of the 10 þ Xand 71.8% of the re-biopsy group reported of hema-tospermia, which lasted between 9.6 and 12.8 days.

Although there is a trend towards a higher rate and aprolonged hematospermia in the 10 þ X and rebiopsygroup, these differences did not reach statistical sig-nificance. No patient was treated for hematospermia.No patient was admitted to hospital because of mor-bidity of prostatic biopsy.

3.4. Patient acceptanceWe also assessed patient acceptance of prostatic

biopsy by a self-administered questionnaire. 89.3%of all patients stated either 1 week or 1 month afterbiopsy that they would be willing to repeat prostatebiopsy, if their urologist would recommend it. 10.7%would not repeat the biopsy any more. Looking at theresults of the questionnaire one week after biopsy95.1% of the sextant biopsy, 96.7% of the 10-corebiopsy group and 93.9% of the re-biopsy group werewilling to repeat this biopsy if necessary. One monthafter biopsy the rate dropped to 90.5% (6 þ X), 98.8%(10 þ X) and 81.8% (re-biopsy). Altogether 5.5% ofpatients changed their opinion, 4.7% would agree after1 week but refuse re-biopsy after 1 month. On the otherhand 0.8% of patients who refused after 1 week wouldhave agreed after 1 month.

4. Discussion

Random systematic sextant biopsy is a widely usedand accepted protocol. Hodge et al. [2] reported in1989 that this procedure is superior in detecting pro-static carcinoma compared to directed biopsies tohypoechoic lesions on transrectal ultrasound. But thesensitivity of random systematic biopsy is only about60% at the first time biopsy (Terris et al. [9]). Thereforenew biopsy strategies are under investigation with twodifferent strategies. The first strategy is increasing corenumbers [3–5], which seems to be intuitive that themore core biopsies are obtained the higher the detec-tion rate will be. The second strategy is to direct thebiopsy cores to distinct areas of the prostate like thelateral peripheral zone or transitional zone to enhanceprostate cancer detection [6,7].

The question is if an increase in core numbers orsampling in distinct areas of the prostate may increasemorbidity of prostatic biopsy. Because the additionalgain in prostate cancer detection rate may be low, anincrease in morbidity would not be acceptable. Thestandard sextant biopsy is regarded a safe procedurewith only few major complications but common minorside effects [8]. In our series we can confirm thishypothesis. We did not see any major complicationin the sextant biopsy group, which would have led to

57,6%

18,3%

2,4% 1,2%

65,3%

72,0%

29,3%

2,2% 3,3%

75,0%70,4%

25,3%

3,5% 1,8%

71,8%

0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

60,0%

70,0%

80,0%

gross hematuria rectal bleeding fever chills hematospermia

6+X10+XRebiopsy

Fig. 4. Rate of observed side effects after biopsy for different prostatic

biopsy strategies.

9,6

0,4

1,9

10,7

0,6

2,4

12,8

0,5

2,9

0,0 2,0 4,0 6,0 8,0 10,0 12,0 14,0

hematospermia

rectal bleeding

gross hematuriaRe-Biopsie

10+X

6+X

days

Fig. 5. Mean duration (days) of observed side effects after biopsy for

different prostatic biopsy strategies.

R. Paul et al. / European Urology 45 (2004) 450–456 453

hospitalization. Not a single patient of the sextantgroup was seeking medical help for side effects afterbiopsy. But the rate of minor complications was sig-nificant. 57.6% of our patients with sextant biopsyreported of gross hematuria, 18.3% of rectal bleeding,65.3% observed hematospermia and 2.4% noted feverabove 38 8C and 1.2% chills despite an antibioticprophylaxis with a gyrase inhibitor for 5 days. Thisrate of morbidity is reported if complications of pro-static biopsy are analyzed in prospective trials [8].Most reports however studied complications retrospec-tively and therefore focused on major complications[10–12]. Naughton et al. [13] reported in their pro-spective trial similar complication rates, in the sextantgroup they found gross hematuria in 49%, hematoche-zia in 10% and hematospermia in 71%. Fever wasnoted in 4% of patients. Similar rates of side effectshave been reported by Rodriguez et al. [8]. Persistenthematuria was observed in 47.1%, hematochezia in9.9%, fever in 1.7% and chills in 2.5%. Only hema-tospermia was seen in only 9.1% of all patients whichwas explained with the low rate of patients whoreported of ejaculation before biopsy in their patientpopulation. All trials demonstrate that major compli-cations requiring medical interventions or inpatientadmission are uncommon.

In contrast to the sextant biopsy regimen morbidityof extensive biopsy protocols has not been studied indetail. There are only few reports of morbidity inextensive biopsy protocols [7,13–15]. Levine et al.[15] reported of only three major complications witha 12-core biopsy regimen and therefore they concludethat increase in morbidity by extensive biopsy proto-cols is negligible. Naughton et al. [13] investigatedmorbidity of a 12-core biopsy strategy versus thesextant biopsy prospectively and found that statisti-cally significant increase in rectal bleeding (24% ver-sus 10%) and hematospermia (89% versus 71%).Hematuria was higher in the 12-core group with60% compared to 49% in the sextant group, but thisdifference was not statistically different. Our data alsosuggest an increase of complications if increasing thecore number, which was not statistical significantdifferent. Hematuria was noted in 57.6% in the sextantgroup and over 70% in the extensive biopsy protocols.We could also demonstrate an increase in morbidity forrectal bleeding from 18.3% to 25.3% and 29.3%respectively and for hematospermia from 65.3% to71.8% and 75.0% respectively, although this differencewas not statistical significant. Our analysis also demon-strates that the increased rate of morbidity, which isfound with extensive biopsy protocols, is not related tosampling in distinct areas of the prostate. The 10 þ X

strategy was limited to sampling in the peripheral zone,there as the re-biopsy group included sampling in theventral part of the transitional zone. Our data suggestthat the core number and not the area of sampling isrelated with complications. Another finding, which hasnot been reported yet, is that the increase in morbidityis not associated with increased severity of side effectsif different areas of the prostate are sampled. Sam-pling in the transitional zone is more difficult becausethe needle has to be inserted deeper into the prostate,as it is necessary for sampling in the peripheral zone.On the other hand sampling of the median peripheralzone may increase morbidity due to the close relationof the urethra. In our two groups of extensive biopsyprotocols sampling was performed either in the t-zoneor the median p-zone additional to the standard sex-tant biopsy. There was no difference in the morbidityin these two biopsy strategies observed, suggestingthat the observed increase in the rate of side effects isdue to the increased number of cores. The fact that wecould not find a statistical significant difference maybe related to the study power of course, but looking atthe differences in the rate we are convinced, that evenif we would find a statistical significant differencelooking at a much larger patient cohort, we probablywould not call it a clinically significant difference,especially because we found only a minor severity ofside effects.

A very important topic of prostatic biopsy is painduring and after biopsy. The sensitivity of the prostaticbiopsy is probably only 70% [9]; therefore a significantsubset of patients will have to undergo a repeat biopsy.If patients experienced significant pain or side effectsduring and after prostatic biopsy it is difficult toconvince these patients about the necessity of repeatbiopsy. Most urologists are convinced that this proce-dure, even with extensive biopsy strategies, can beperformed without anesthesia [16]. However most ofthe published papers do not evaluate pain in thisrespect. Irani et al. [17] reported of a subset of 16%of patients who had significant discomfort duringbiopsy measured by a visual analog scale, Collinset al. [11] found significant pain in 22% and Clemenset al. [18] and Rodriguez et al. [8] even report of 30%.In our study we used a lidocain jelly transrectally aslocal anesthesia. We do not think that this jelly has apronounced effect on reducing pain, but it facilitatesinserting of the ultrasound probe through the analsphincter. Also we think that this procedure has animpact on reducing the psychological distress of thepatient. In this regard only 5.9% of patients whoreceived the standard sextant biopsy report of severepain and 24.7% of moderate pain. These data are

454 R. Paul et al. / European Urology 45 (2004) 450–456

conclusive with the literature that about 30% ofpatients will experience significant pain. In our exten-sive biopsy protocols the rate of significant pain did notchange. However after biopsy the rate of pain freepatients decreased from 54.1% in the sextant group to38.0% and 42.1% respectively for the questionnaire 1week after biopsy. 1 month after biopsy this differenceis diminishing. Pain during micturition after biopsy is arare finding but it is increasing from 1.2% in the sextantgroup to over 6% in the extensive biopsy protocols.This may be due to a pronounced swelling of theprostate if more biopsy cores are taken. Pain duringbowel movement is also a rare finding after prostatebiopsy and there was no difference for different biopsystrategies.

Although most of the patients will undergo a pro-static biopsy without significant discomfort during andafter biopsy, a significant subset, about one third of allpatients, will experience significant pain, thereforelocal anesthesia as suggested with a local analgesic[19] or local nerve blockade [20] should be consideredfor this procedure.

Patient acceptance of prostate biopsy is stronglycorrelated with morbidity and pain during and after

the procedure. In our study most of patients stated thatthey would agree to repeat the biopsy if their urologistwould recommend it. The rate of acceptance dropped ifpatients were asked one month after biopsy, mostlyrelated to the histology report. There was differencein regard of the biopsy strategy and also looking atprostate cancer patients and non cancer patients wecould not find a statistical significant difference.

5. Conclusion

This study emphasizes that prostate biopsy is a safeprocedure with rare major complications but commonminor side effects. Extensive biopsy protocols withincreased numbers of biopsy cores are slightly increas-ing the rate of complications, but not the severity ofsymptoms. The area of sampling in the prostate is notrelated with the rate and severity of complications.Prostate biopsy is associated with significant pain inabout one third of the patients regardless the biopsystrategy, but patient acceptance is very high with over90% of patients willing to repeat prostate biopsy ifnecessary.

References

[1] Djavan B, Remzi M, Ghawidel K, Marberger M. Diagnosis of

prostate cancer: the clinical use of transrectal ultrasound and biopsy.

EAU update series 2003;1:9–15.

[2] Hodge KK, McNeal JE, Terris M, Stamey TA. Random systematic

versus directed ultrasound guided transrectal core biopsies of the

prostate. J Urol 1989;142:71–4.

[3] Chen ME, Troncoso P, Tang K, Babaian RJ, Johnston D. Comparison

of prostate biopsy schemes by computer simulation. Urology

1999;53:951–60.

[4] Stricker HJ, Ruddock LJ, Wan J, Belville WD. Detection of

nonpalpable prostate cancer. A mathematical and laboratory model.

Br J Urol 1997;71:43–6.

[5] Naughton CK, Miller DC, Mager DE, Ornstein DK, Catalona WJ. A

prospective randomized trial comparing 6 versus 12 prostate biopsy

cores: impact on cancer detection. J Urol 2000;164:388–92.

[6] Chen ME, Troncoso P, Johnston DA, Tang K, Babaian RJ.

Optimization of prostate biopsy strategy using computer based

analysis. J Urol 1997;158:2168–75.

[7] Eskew LA, Bare RL, McCullough DL. Systematic 5 region prostate

biopsy is superior to sextant method for diagnosing carcinoma of the

prostate. J Urol 1997;157:199–202.

[8] Rodriguez LV, Terris MK. Risks and complications of transrectal

ultrasound guided prostate needle biopsy: a prospective study and

review of the literature. J Urol 1998;160:2115–20.

[9] Terris MK. Sensitivity and specificity of sextant biopsies in the

detection of prostate cancer: preliminary report. Urology 1999;54:

486–9.

[10] Cooner WH, Mosley BR, Rutherford CL, Beard JH, Pond HS, Terry

WJ, et al. Prostate cancer detection in a clinical urological practice

by ultrasonography, digital rectal examination and prostate specific

antigen. J Urol 1990;143:1146–52.

[11] Collins GN, Lloyd SN, Hehir M, McKelvie GB. Multiple transrectal

ultrasound-guided biopsies – true morbidity and patient acceptance.

Br J Urol 1993;71:460–3.

[12] Gustafsson O, Norming U, Myman CR, Ohstrom M. Complications

following combined transrectal aspiration and core biopsy of the

prostate. Scand J Urol Nephrol 1990;24:249–51.

[13] Naughton CK, Ornstein DK, Smith DS, Catalona WJ. Pain and morbi-

dity of transrectal ultrasound guided prostate biopsy: a prospective

randomized trial of 6 versus 12 cores. J Urol 2000;163:168–71.

[14] Horninger W, Reissigl A, Fink K, Pointner J, Strasser H, Bartsch G.

Results of a prospective randomised study comparing the prostate

cancer detection rates in PSA screening volunteers undergoing 10 vs.

14 transrectal ultrasound guided biopsies. J Urol 1998;159:180A.

[15] Levine MA, Ittmann M, Melamed J, Lepor H. Two consecutive sets

of transrectal ultrasound guided sextant biopsies of the prostate for

detection of prostate cancer. J Urol 1998;159:471–5.

[16] Ravery V, Goldblatt L, Royer B, Blanc E, Toublanc M, Boccon-

Gibod L. Extensive biopsy protocol improves the detection rate of

prostate cancer. J Urol 2000;164:393–6.

[17] Irani J, Fournier F, Bon D, Gremmo E, Dore B, Aubert J. Patient

tolerance of transrectal ultrasound-guided biopsy of the prostate. Br J

Urol 1997;79:608–10.

[18] Clements R, Aideyan OU, Griffiths GJ, Peeling WB. Side effects and

patient acceptability of transrectal biopsy of the prostate. Clin Rad

1993;47:125–6.

[19] Haq A, Habib M, Donaldson PJ, Pary JR. The role of analgesia in the

form of voltarol suppositories prior to TRUS and prostate biopsy—a

double blind placebo controlled trial. J Urol 2002;167S:1316.

[20] Vaidya A, Soloway MS. Periprostatic local anesthesia before

ultrasound-guided prostate biopsy: an update of the Miami experience.

Eur Urol 2001;40:135–8.

R. Paul et al. / European Urology 45 (2004) 450–456 455

Editorial CommentBob Djavan, Vienna, Austria

The current literature is confident about the fact thatroutine sextant biopsies are basically historical.Although this may sound too strong a statement forsome, it is evident that the number of cores to be takenduring TRUS guided biopsy cannot be a set number ineach and every patient. It is indeed a decision that needsto be made based on multiple factors such as prostatevolume, patient age and serum PSA level; This numberis individual to each patient and reflects the degree ofsuspicion gathered from various clinical and biochem-ical parameters. We have recently introduced theVIENNA Nomograms that are now validated in over1200 patients in Europe and the US. It offers an easytool to detect the accurate number of cores based on

prostate volume and age. Clearly morbidity is expectedto increase when adding additional cores. Interestingly,this is not the case and although the absolute numbersmay increase, no statistical significant differences wereobserved when looking at the European Prostate CancerDetection Study (EPCDS). Two lessons however werelearned; (1) despite no differences in overall morbidity,younger patients (<65 years of age) had a higher painapprehension than older patients and thus some form ofpain medication (additional IV sedation) may be appro-priate; (2) repeat biopsies also do not add significantmorbidity. Even when the number of cores was sig-nificantly increased as suggested by the VIENNANomograms, morbidity did not increase. A review ofthe literature shows however that few authors recom-mend additional sedation (to transrectal xylocaine gel)when more than 12 cores are taken.

456 R. Paul et al. / European Urology 45 (2004) 450–456