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ORIGINAL ARTICLE Table of Contents  
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Outcomes and complications after transrectal ultrasound-Guided prostate biopsy: A single-Center study involving 425 consecutive patients

1 Department of Urology, School of Medicine, College of Medicine, Kaohsiung Medical University; Department of Urology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
2 Department of Urology, School of Medicine, College of Medicine, Kaohsiung Medical University; Department of Urology, Kaohsiung Medical University Hospital; Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
3 Department of Urology, School of Medicine, College of Medicine, Kaohsiung Medical University; Department of Urology, Kaohsiung Medical University Hospital; Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University; Department of Urology, Ministry of Health and Welfare Pingtung Hospital, Pingtung, Taiwan
4 Department of Urology, School of Medicine, College of Medicine, Kaohsiung Medical University; Department of Urology, Kaohsiung Medical University Hospital; Department of Urology, Ministry of Health and Welfare Pingtung Hospital, Pingtung; Department of Urology, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan

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Objective: The use of 10–12-core systemic transrectal ultrasound (TRUS)-guided prostate biopsy protocols with extended-sampling has been an optimizing strategy for diagnosis of prostate cancer. In this study, we aim to examine the cancer detection rate (CDR) and the complications following prostate biopsy at our institution. Materials and Methods: We retrospectively reviewed medical data of patients who underwent TRUS-guided prostate biopsy between 2007 and 2013 at our institution. The pathological outcomes, major complications, and morbidities were recorded and assessed clinically. Results: During the study period, 425 patients who underwent TRUS-guided prostate biopsy were enrolled. The mean age of the participants was 67.9 years. Overall, 75 (17.6%) patients were diagnosed with prostate cancer. Cancer was detected in 0% (0/10), 7.0% (15/215), 16.5% (20/121), and 50.6% (40/79) of patients in the subgroups with patient prostate-specific antigen (PSA) <4 ng/ml, 4–10 ng/ml, 10–20 ng/ml, and >20 ng/ml, respectively. The optimal cutoff values of PSA density were 0.19, 0.29, and 0.78 in the subgroups with patient PSA 4–10 ng/ml, 10–20 ng/ml, and >20 ng/ml. In total, 11 patients had afebrile urinary tract infections (UTI), 9 patients had febrile UTI, and another 2 patients had septic shock after biopsy. The overall incidence of infectious complications was 5.17% (22/425). Other complications were infrequent, consisting only of urinary retention in three patients, hematospermia in two patients, and acute hemorrhagic cerebellar infarction in 1 patient. Conclusion: Our study demonstrated the CDR, the incidence, and type of complications following TRUS-guided prostate biopsy. Further prospective studies are required to determine methods for reducing complications from prostate biopsy.

Keywords: Cancer detection rate, prostate specific antigen density, prostate cancer, prostate-specific antigen, transrectal ultrasound-guided prostate biopsy

How to cite this URL:
Jhan JH, Huang SP, Li WM, Li CC, Huang TY, Ke HL, Huang CN, Chou YH, Wen SC. Outcomes and complications after transrectal ultrasound-Guided prostate biopsy: A single-Center study involving 425 consecutive patients. Urol Sci [Epub ahead of print] [cited 2019 Jan 19]. Available from: http://www.e-urol-sci.com/preprintarticle.asp?id=233160

  Introduction Top

Prostate cancer is the most common solid organ cancer and the second leading cause of malignancy-related mortality in men worldwide.[1] Almost 1 million biopsies are performed annually in the US to confirm or rule out prostate cancer.[2] Most of these biopsies were conducted using transrectal approach under ultrasound guidance. Although several techniques, including the transperineal approach, are available for optimization of prostate biopsy, transrectal ultrasound (TRUS)-guided biopsy is currently the standard procedure to obtain tissue samples for pathological diagnosis of prostate cancer.

The American Urological Association and Taiwan Urological Association guidelines recommended the use of an extended 10–12-core biopsy incorporating far-lateral and apical samples for TRUS-guided prostate biopsy. The cancer detection rate (CDR) can reach up to >40% if tissue cores are obtained systemically throughout the prostate.[3] Although previous studies have shown that prostate-specific antigen (PSA) density plays a significant role in prostate cancer screening by increasing the diagnostic value of PSA,[4] the optimal cutoff value of PSA density is still controversial.

The most common side effects and complications of a prostate biopsy include hematuria, rectal bleeding, hematospermia, symptomatic UTI, and urinary retention.[5] Infectious complications range from asymptomatic UTI to septic shock, and their incidence has increased in recent years, with febrile episodes rising from 1% to 4% in some retrospective and prospective studies.[6] However, no local or national database regarding CDR, PSA density, and postbiopsy complications is available in Taiwan. To address these issues, we reviewed our medical data of patients who underwent TRUS-guided prostate biopsy to investigate the CDR and PSA density and examine the type and incidence of complications that develop following prostate biopsy at our institution.

  Materials and Methods Top

This retrospective study was approved by the Institutional Review Board of Kaohsiung Medical University Hospital. We enrolled 425 men who underwent TRUS-guided prostate biopsy at our institute between August 2007 and October 2013. All patients had an elevated level of serum PSA or abnormal findings on digital rectal examination (DRE). The patients' baseline characteristics including age, body mass index, renal function, serum PSA level, measured prostate volume, and comorbidities, such as hypertension, diabetes, active or chronic pulmonary diseases, and liver disease, were recorded. Patients with incomplete demographic data or those lost to follow-up were excluded from the study. Data were obtained by retrospectively reviewing the medical charts and examining the pathohistological results as well as complications following prostate biopsies.

PSA density was tested for its ability to predict prostate cancer using receiver operating characteristic (ROC) curves. We examined the ROC analysis to determine the optimal sensitivity and specificity using various cutoff values. The overall performance of the ROC analysis was quantified by computing the area under the curve. An area of 1 indicated perfect performance, while 0.5 indicated a performance that was no different than chance. Statistical significance was defined as P < 0.05. All statistical analyses were performed using the SAS 9.3.1 Statistical Package (SAS Institute Inc., Cary, NC, USA)

Biopsy techniques and protocols

We use 10–12-core extended-sampling systemic biopsy protocols for the peripheral zone under ultrasound guidance. Local anesthesia with lidocaine jelly was used not only as a lubricant to reduce friction during instrument insertion but also to relieve the discomfort resulting from needle penetration and the introduction of the ultrasound probe. Our protocol for antibiotic prophylaxis involves administering a single dose of intravenous fluoroquinolone or intramuscular gentamicin before biopsy and subsequently prescribing oral fluoroquinolone or third-generation cephalosporin for 3 days. The rectum is prepared through application of monosodium phosphate anhydrous enema the night before or on the morning of the procedure. Preoperative screening with rectal swabs or urine cultures was not routinely performed. Most of these patients were discharged on the day or the next day after the procedure.

  Results Top

The mean age of all participants was 67.9 years. Overall, 75 cases were diagnosed as prostate cancer (17.6%, 75/425), and another three cases were diagnosed as prostatic intraepithelial neoplasia. Patients were divided into four subgroups according to their PSA level: Group 0 (PSA <4 ng/ml), Group 1 (PSA 4–10 ng/ml), Group 2 (PSA 10–20 ng/ml), and Group 3 (PSA >20 ng/ml). [Table 1] shows the baseline characteristics and comorbidities of the four groups. Malignancy was detected in 0% (0/10), 7.0% (15/215), 16.5% (20/121), and 50.6% (40/79) in Group 0, 1, 2, and 3, respectively. [Figure 1] shows the ROC curves of the Group 1, 2, and 3. The optimal cutoff values of PSA density were 0.19 in Group 1, 0.29 in Group 2, and 0.78 in Group 3. While using these cutoff values of PSA density to predict prostate cancer, the sensitivity and specificity were 71.4% and 68.2% in Group 1, 95.0% and 58.4% in Group 2, and 82.5% and 69.2% in Group 3, respectively.
Table 1: Patients' demographics

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Figure 1: The receiver operating characteristic curves of the Group 1, 2, and 3

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With regard to complications following biopsy, 11 patients had afebrile UTI, 9 patients had febrile UTI, and another 2 patients experienced septic shock after biopsy. The overall incidence of post-TRUS biopsy infective complications was 5.17% (22/425). Other complications were infrequent. Only three patients developed urinary retention and required temporary urethral catheter indwelling after biopsy. Two patients reported hematospermia during follow-up, but these conditions were self-limiting. One patient who had a history of cerebral vascular accident had subsequent acute hemorrhagic cerebellar infarction on the next day of his biopsy. No post biopsy-related mortality occurred.

  Discussion Top

This study examined the CDR and the major complications following TRUS-guided prostate biopsy at our hospital as a local database. Evidence has shown the benefit of a 10–12-core systemic biopsy incorporating far-lateral and apical cores that allow maximal cancer detection and prevent repeat biopsy without increasing the detection of insignificant cancers.[7] By applying this extended 10-core biopsy strategy, Babaian et al. demonstrated a CDR of 34% among 85 patients who underwent primary biopsy.[8] With regard to the number of biopsy cores, previous studies showed that an extended 10–12-core biopsy protocol has a significantly higher CDR than a 6-sample (sextant) protocol.[8],[9] However, even though the increase of the biopsy cores from 6 to 12 might improve the CDR by 22%, a similar outcome is not obtained when the number of cores is increased from 12 to 18 or 21.[9] In their study, de la Taille et al. reported that the CDR of sextant, extended 12-core, 18-core, and saturation 21-core biopsy schemes were 22.7%, 28.3%, 30.7%, and 31.3%, respectively. When the number of cores increased from 6 to 12, the CDR improved by 24.7%. By contrast, the CDR only improved by 10.6% when the number of cores was increased from 12 to 21.[10] A systematic review also revealed that the 12-core biopsy improves the diagnostic yield by 31% compared with the sextant schemes; however, biopsies with 18–24 cores did not detect significantly more cancers.[11]

Using more than 12 cores in initial biopsy might potentially result in the detection of insignificant prostate cancer. A previous study has shown that an extended 18-core biopsy strategy might increase the detection rate of indolent prostate cancer by 22%.[12] Bjurlin et al. also reported that the use of more than 12 cores did not improve the false-negative rate of cancer detection but further increased the risk of identifying insignificant cancer and the medical costs.[13] Moreover, the CDR of repeat saturation biopsy after initial saturation biopsy was 24%, which is similar to the CDR of 29% for saturation biopsy after initial sextant biopsy.[14] Therefore, current evidence does not support the use of saturation biopsy as an initial biopsy strategy.

Another concern in prostate biopsy is the location of core biopsy. Because only very few malignancies are found uniquely in the transitional zone, previous studies did not support the usefulness of routine transitional zone biopsy and midline sampling as an initial biopsy.[8],[9],[15],[16] In contrast, research showed that apical and far-lateral region-sampling might increase CDR and also reduce the need for repeat biopsies. Babaian et al. evaluated 85 patients who underwent first biopsy, and 7 cancers were identified uniquely in the anterior-horn (far lateral) and only 2 cancers were found uniquely in the transitional zone.[8] Singh et al. also demonstrated the benefit of lateral sampling and showed that laterally directed cores are independent predictors of pathological features in prostatectomy.[17] Furthermore, in their study involving 181 men who underwent extended 12-core biopsy strategy plus 2 additional cores taken from the extreme anterior apex, Moussa et al. reported that extreme apical cores increased the rate of prostate cancer detection and reduced the potential for misdiagnosis.[18] In our protocol for prostate biopsy, we did not perform transitional zone biopsy, and apical and far-lateral region sampling is not routinely performed. This can be among the reasons why our CDR (17.6%, 75/425) was relatively low compared with previous studies (27%–52% with 10–12-core biopsy strategy).[8]

The serum PSA level and the DRE results are fundamental elements in the CDR. Guichard et al. divided their 1000 patients into three subgroups according to serum PSA level and reported that, when comparing 12 with 21 biopsy cores, the improvement in diagnostic yield was 13.6%, 12.6%, and 7.3%, respectively, in the subgroups of patients with PSA <4 ng/ml, 4–10 ng/ml, and PSA 10–20 ng/ml. Similarly, in patients with normal DRE, a 21-core biopsy can detect 9.8% more cancers than the 12-core technique; however, the diagnosis yield is improved by only 1.8% in abnormal DRE population.[9] In addition to PSA values, TRUS findings, and DRE examinations, the use of PSA density as an indicator for prostate biopsy has generated controversy. Given the fact that the incidence of prostate cancer is relatively low in Asian countries, we used to apply PSA density with a cutoff level of 0.15 to promote prostate biopsy in patients with intermediate PSA values (4–10 ng/ml) based on Western references. However, the optimal cutoff values of PSA density remain unclear in Asian area, especially in the Far East. Emerging literature has described that a higher PSA density cutoff level (0.19) in patients with intermediate PSA values can detect prostate cancer with a sensitivity of 100% and a specificity of 79%.[19] Recent studies have shown that PSA density is an accurate preoperative tool to predict adverse pathologic features including extracapsular extension, positive surgical margins, seminal vesicle, and lymph node invasion.[20] Our present results demonstrated the optimal cutoff values of PSA density in different groups which can be used as an adjunct in predicting outcomes after radical prostatectomy.

From our experience, the overall incidence of infectious complications was 5.17% (22/425), consisting of afebrile UTI in 11 patients, febrile UTI in 9 patients, and septic shock in another 2 patients. Most of the patients experienced temporary gross hematuria or rectal pain, which soon resolved spontaneously. Previous studies showed that the incidence of biopsy-related infectious complications ranged from 0.1% to 7%, and roughly 30%–50% of these patients have bacteremia.[21] The hospital admission rates for infectious complications have increased from 1.0% in 1996 to 4.1% in 2005 (P for trend < 0.0001),[22] which may be related to increasing incidence of antibiotic resistance. Bacteremia is frequently accompanied by severe sepsis and may sometimes be life threatening. In a database from a medical center in Lebanon, among 207 men who underwent TRUS-guided prostate biopsy, 13 patients (6.3%) were admitted due to febrile UTI. A total of 8 patients (61.5%) had a positive urine culture and 6 patients (46.2%) had positive blood culture. All these cultures grew Escherichia coli resistant to fluoroquinolone, with 5 isolates producing extended-spectrum beta-lactamases.[23] Another study focused on fluoroquinolone-resistant E. coli bloodstream infection revealed that, compared with men with community-onset E. coli bacteremia, patients who acquired E. coli bacteremia due to TRUS-guided prostate biopsy had a two times higher risk of intensive care admission (25% vs. 12%), with significantly higher rates of resistance to gentamicin (43%), trimethoprim-sulfamethoxazole (60%), and ciprofloxacin (62%) as well as all three agents in combination (19%).[24]

To the best of our knowledge, this study is the first local database that demonstrated the CDR, optimal cutoff values of PSA density, and the incidence rate and type of complications following TRUS-guided prostate biopsy in Taiwan. Given the increasing incidence of antibiotic resistance, antimicrobial prophylaxis practices should be reevaluated, and further prospective studies to determine methods for reducing complications from prostate biopsy are needed.

  Conclusion Top

In our experience, the use of extended 10–12-core biopsy strategy can provide optimal detection rate of prostate cancer without increasing the likelihood of detecting insignificant cancers. The optimal cutoff values of PSA density in patients with intermediate PSA levels (4–10 ng/ml) and high PSA levels (10–20 ng/ml) were 0.19 and 0.29. TRUS-guided prostate biopsy is a relatively safe procedure, and most complications following prostate biopsy were UTI and sepsis. Physicians need to recognize the benefits and risks of prostate biopsy and discuss biopsy-related outcomes and complications with patients in detail.


The authors would like to acknowledge the Statistical Analysis Laboratory in the Department of Medical Research at Kaohsiung Medical University Hospital.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

  References Top

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Welch HG, Fisher ES, Gottlieb DJ, Barry MJ. Detection of prostate cancer via biopsy in the medicare-SEER population during the PSA era. J Natl Cancer Inst 2007;99:1395-400.  Back to cited text no. 2
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Benson MC, Whang IS, Pantuck A, Ring K, Kaplan SA, Olsson CA, et al. Prostate specific antigen density: A means of distinguishing benign prostatic hypertrophy and prostate cancer. J Urol 1992;147:815-6.  Back to cited text no. 4
Loeb S, Vellekoop A, Ahmed HU, Catto J, Emberton M, Nam R, et al. Systematic review of complications of prostate biopsy. Eur Urol 2013;64:876-92.  Back to cited text no. 5
Wagenlehner FM, Pilatz A, Waliszewski P, Weidner W, Johansen TE. Reducing infection rates after prostate biopsy. Nat Rev Urol 2014;11:80-6.  Back to cited text no. 6
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Bazinet M, Karakiewicz PI, Aprikian AG, Trudel C, Aronson S, Nachabé M, et al. Value of systematic transition zone biopsies in the early detection of prostate cancer. J Urol 1996;155:605-6.  Back to cited text no. 15
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Correspondence Address:
Shen-Chen Wen,
Department of Urology, School of Medicine, College of Medicine, Kaohsiung Medical University, No. 100, Shiquan 1st Road, Sanmin, Kaohsiung 807
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Source of Support: None, Conflict of Interest: None


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