Biopsy quality criteria

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For men undergoing an initial prostate biopsy how many biopsy cores, which pattern of biopsy sampling sites and which approach constitute an adequate prostate biopsy? (PICO questioni 7)

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  Cite this guideline

Prostate Cancer Foundation of Australia and Cancer Council Australia PSA Testing Guidelines Expert Advisory Panel. Clinical practice guidelines PSA Testing and Early Management of Test-Detected Prostate Cancer. Sydney: Cancer Council Australia. [Version URL: http://wiki.cancer.org.au/australiawiki/index.php?oldid=122833, cited 2017 Nov 23]. Available from: http://wiki.cancer.org.au/australia/Guidelines:PSA_Testing/Biopsy_quality_criteria.

National Health and Medical Research Council These guidelines (recommendations) in the web-version of this guideline were approved by the Chief Executive Officer of the National Health and Medical Research Council (NHMRC) on 2 November 2015 under section 14A of the National Health and Medical Research Council Act 1992. expand arrow

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In approving the guidelines (recommendations), NHMRC considers that they meet the NHMRC standard for clinical practice guidelines. This approval is valid for a period of five years. NHMRC is satisfied that the guidelines (recommendations) are systematically derived, based on the identification and synthesis of the best available scientific evidence, and developed for health professionals practising in an Australian health care setting.

This publication reflects the views of the authors and not necessarily the views of the Australian Government.

Background

Core biopsy of the prostate with histological examination is indicated when investigations undertaken after the finding of raised PSA support the suspicion of prostate cancer (see 2.5 Testing with variants of PSA to improve sensitivity after an initial total PSA ≤ 3.0 ng/mL and 2.6 Testing with variants of PSA or repeat PSA testing to improve specificity after an initial total PSA > 3.0 ng/mL).

The purpose of core biopsy is to confirm the presence of cancer. If prostate cancer is confirmed, its type, grade and likely extent within the prostate is determined before definitive treatment is considered. A traditional approach was to collect a single core biopsy from six zones of the prostate (sextant biopsy). Current clinical practice varies considerably in the number of cores collected, with multiple cores taken from these six zones and extra cores directed at different areas of the prostate.

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Evidence

One systematic review,[1] seven randomised controlled trials[2][3][4][5][6][7][8][9][10][11] and 15 sequential sampling studies[12][13][14][15][16][17][18][19][7][20][21][8][9][22][23] (three[7][8][9] with sequential sampling in an intervention arm) were identified that provided evidence relevant to determining an optimal number of core biopsies, biopsy site, and surgical approach. From an initial 12,667 citations, 109 studies in 23 articles met inclusion criteria for the review (22 articles reporting one study each[2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] and one systematic review reporting data from 87 studies[1]). The search strategy, inclusion and exclusion criteria, and quality assessment are described in detail in the Technical report.

The systematic review[1] compared the cancer detection rates and complications of different extended prostate biopsy schemes for diagnostic evaluation in men scheduled for biopsy. It reported that ‘the standard sextant scheme has a significantly lower cancer yield than most of the more extensive biopsy schemes. As the number of cores increases, the yield improves for most of the schemes.’ However, the review did not determine an optimal biopsy number and did not disentangle the independent effects of increasing core numbers and biopsy location.

Studies published since the systematic review examined a diversity of proposed schemes and comparisons. We performed a patient-level regression analysis using data from nineteen additional studies that compared various biopsy protocols.[12][13][14][4][15][5][6][16][17][19][7][20][21][8][9][10][11][22][23] Across the included studies, 23,822 biopsy components from 8,221 men were assessed for all cancers and 9,851 biopsy components from 3,701 men were assessed for cancers with Gleason score greater than 6.

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Number of cores

For any given biopsy region or set of regions, men who had 24 cores taken had nearly double the odds of having cancer detected than men who had six cores taken (odds ratio [OR] 1.98; 95% confidence interval [CI] 1.52–2.58). There was also a clinically significant increase in cancer detection rate between 12 biopsies (45.6%) and 24 biopsies (56.9%) for populations in which the 6-core sextant scheme was predicted to yield 40%.

Evidence for adverse event rates was limited. It was not possible to compare rates of adverse events between groups who underwent biopsy with different numbers of cores.

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Site of cores sampled

For a given number of cores, taking samples from the peripheral zones (i.e. the lateral peripheral zone [LPZ] and/or the mid-peripheral zone [MPZ]) yielded more cancers than taking samples from the transitional zone. The relative increases in yield from increasing core numbers was similar for higher-grade (Gleason score > 6) cancers and all cancers. Overall, the evidence did not show that, for a given number of cores, sampling regions in addition to the peripheral zones (i.e. LPZ and/or MPZ) led to increases in cancer yield.

Evidence for adverse event rates was limited. It was not possible to compare rates of adverse events between groups who underwent biopsy with different sampling sites.

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Biopsy approach

There was insufficient evidence to determine if the transperineal approach was superior to the transrectal approach for cancer detection. None of the included studies measured concordance between biopsy and post-prostatectomy histopathology in individual patients.

Two studies[3][11] directly compared adverse events in men who underwent 12-core biopsy using the transperineal and transrectal approaches. In one study,[3] the perineal approach was associated with a significantly higher rate of headaches. Neither reported differences in other adverse events, including fever and sepsis (reported in one study).[3] Neither study reported infection rates.

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Evidence summary and recommendations

Evidence summary Level References
Detection of prostate cancer

Increasing biopsy core number improves cancer yield; as the number of cores increases, the yield increases. A patient-level regression analysis showed that:

  • for any given biopsy region or set of regions, men who have 24 cores taken had nearly double the odds of having cancer detected than men who had 6 cores taken
  • the 24-core biopsy had a clinically significant greater diagnostic yield of 56.9%, compared with 45.6% for a 12 core biopsy and an expected yield of 40% for a 6-core biopsy.

For a given number of cores, taking samples from the peripheral zones (i.e. LPZ and/or MPZ) yielded more cancers than the transitional zone.

I [12], [13], [1], [14], [4], [15], [5], [6], [16], [17], [19], [7], [20], [21], [8], [9], [10], [11], [22], [23]
Detection of prostate cancer

There is insufficient evidence to determine if the transperineal approach is superior to the transrectal approach in detecting cancer.

I [12], [13], [14], [4], [15], [5], [6], [16], [17], [19], [7], [20], [21], [8], [9], [10], [11], [22], [23]
Detection of cancer with Gleason score > 6

The relative increases in yield from increasing core numbers was similar for higher-grade cancers (Gleason score > 6) and all cancers.

Overall, the evidence did not show that, for a given number of cores, sampling regions in addition to the peripheral zones (i.e. LPZ and/or MPZ) led to either an increase or a decrease in yield of cancers with Gleason score > 6.

There is insufficient evidence to determine if the transperineal approach is superior to the transrectal approach in detecting cancers with Gleason score > 6.

I [7], [20], [21], [8], [9], [10]
Adverse events

Evidence on adverse events is limited.

Differences in adverse event rates were not consistently associated with the number of core biopsies or with the biopsy pattern.

II [1], [4], [5], [6], [7], [9], [10]
Adverse events

There is insufficient evidence to determine whether the transperineal approach is consistently associated with a lower rate of adverse events than the transrectal approach.

II [3], [11]
Evidence-based recommendationQuestion mark transparent.png Grade
Take 21–24 cores in initial biopsies for the diagnosis of prostate cancer. In addition to the sextant biopsies, direct 15–18 additional biopsies to the peripheral zones of the prostate.
B



Practice pointQuestion mark transparent.png

Before offering biopsy after an elevated total PSA test result, take into account a man’s family history of prostate cancer (see Chapter 1 Risk) and the results of further investigations (see 2.5 Testing with variants of PSA to improve sensitivity after an initial total PSA ≤ 3.0 ng/mL and 2.6 Testing with variants of PSA or repeat PSA testing to improve specificity after an initial total PSA > 3.0 ng/mL).


Practice pointQuestion mark transparent.png

Transrectal and transperineal biopsy approaches are both acceptable with respect to rates of cancer detection. The approach taken should be based on the man’s wishes, the surgeon’s experience, risk of sepsis and other morbidity, and practical issues such as cost and access to the necessary facilities.

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Health system implications

Clinical practice

While the recommendation has already been adopted by some urologists, some routinely collect fewer biopsy samples. Accordingly, implementation of the recommendation would result in an increased number of core biopsies per patient, which could increase morbidity and infection rates.

Implementation of this recommendation may result in prostate biopsy becoming a procedure that is mainly performed in operating theatres and with general anaesthesia.

Resourcing

Implementation of this recommendation would result in a small increase in the time needed to perform biopsies and a modest increase in pathology costs. No changes in equipment would be needed unless transperineal biopsy with template is considered.

Barriers to implementation

No barriers to the implementation of this recommendation are envisaged.

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Footnote

i Clinical questions were translated into the PICO framework: population, intervention (or exposure), comparator and outcome (see Appendix 3).

References

  1. 1.0 1.1 1.2 1.3 1.4 Eichler K, Hempel S, Wilby J, Myers L, Bachmann LM, Kleijnen J. Diagnostic value of systematic biopsy methods in the investigation of prostate cancer: a systematic review. J Urol 2006 May;175(5):1605-12 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/16600713.
  2. 2.0 2.1 Alireza N,Pegah N. A prospective randomized comparison of diagnostic efficacy between transperineal and transrectal 12-core prostate biopsy. 2012 Aug 22-26; Pattaya, Thailand. Japan: International Journal of Urology; 2012.
  3. 3.0 3.1 3.2 3.3 3.4 3.5 Hara R, Jo Y, Fujii T, Kondo N, Yokoyoma T, Miyaji Y, et al. Optimal approach for prostate cancer detection as initial biopsy: prospective randomized study comparing transperineal versus transrectal systematic 12-core biopsy. Urology 2008 Feb;71(2):191-5 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18308081.
  4. 4.0 4.1 4.2 4.3 4.4 4.5 Irani J, Blanchet P, Salomon L, Coloby P, Hubert J, Malavaud B, et al. Is an extended 20-core prostate biopsy protocol more efficient than the standard 12-core? A randomized multicenter trial. J Urol 2013 Jul;190(1):77-83 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23313205.
  5. 5.0 5.1 5.2 5.3 5.4 5.5 Lecuona A, Heyns CF. A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol. BJU Int 2011 Jul;108(2):204-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21087452.
  6. 6.0 6.1 6.2 6.3 6.4 6.5 Mariappan P, Chong WL, Sundram M, Mohamed SR. Increasing prostate biopsy cores based on volume vs the sextant biopsy: a prospective randomized controlled clinical study on cancer detection rates and morbidity. BJU Int 2004 Aug;94(3):307-10 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15291857.
  7. 7.0 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 Park HK, Lee KY, Kim KH, Jung H, Yoon SJ, Kim TB. Intermediate versus low or high prostate-specific antigen density level: comparison of cancer detection rate between 12- and 18-core prostate biopsy. Scand J Urol Nephrol 2010 Dec;44(6):391-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20695726.
  8. 8.0 8.1 8.2 8.3 8.4 8.5 8.6 8.7 Rochester MA, Griffin S, Chappell B, McLoughlin J. A prospective randomised trial of extended core prostate biopsy protocols utilizing 12 versus 15 cores. Urol Int 2009;83(2):155-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19752609.
  9. 9.0 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 Rodríguez-Covarrubias F, González-Ramírez A, Aguilar-Davidov B, Castillejos-Molina R, Sotomayor M, Feria-Bernal G. Extended sampling at first biopsy improves cancer detection rate: results of a prospective, randomized trial comparing 12 versus 18-core prostate biopsy. J Urol 2011 Jun;185(6):2132-6 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21496851.
  10. 10.0 10.1 10.2 10.3 10.4 10.5 10.6 Sur RL, Borboroglu PG, Roberts JL, Amling CL. A prospective randomized comparison of extensive prostate biopsy to standard biopsy with assessment of diagnostic yield, biopsy pain and morbidity. Prostate Cancer Prostatic Dis 2004;7(2):126-31 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/15111980.
  11. 11.0 11.1 11.2 11.3 11.4 11.5 11.6 Takenaka A, Hara R, Ishimura T, Fujii T, Jo Y, Nagai A, et al. A prospective randomized comparison of diagnostic efficacy between transperineal and transrectal 12-core prostate biopsy. Prostate Cancer Prostatic Dis 2008;11(2):134-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17533394.
  12. 12.0 12.1 12.2 12.3 12.4 Bittner N, Merrick GS, Bennett A, Butler WM, Andreini HJ, Taubenslag W, et al. Diagnostic Performance of Initial Transperineal Template-guided Mapping Biopsy of the Prostate Gland. Am J Clin Oncol 2013 Jun 11 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23764680.
  13. 13.0 13.1 13.2 13.3 13.4 Dai B, Ye DW, Kong YY, Shen YJ, Wang BH. Individualized prostate biopsy strategy for Chinese patients with different prostate-specific antigen levels. Asian J Androl 2008 Mar;10(2):325-31 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18097514.
  14. 14.0 14.1 14.2 14.3 14.4 Ficarra V, Novella G, Novara G, Galfano A, Pea M, Martignoni G, et al. The potential impact of prostate volume in the planning of optimal number of cores in the systematic transperineal prostate biopsy. Eur Urol 2005 Dec;48(6):932-7 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/16202510.
  15. 15.0 15.1 15.2 15.3 15.4 Janane A, Ould Ismail T, Hajji F, Ghadouane M, Ameur A, Abbar M. Saturation biopsy performed safely could enhance the detection of prostate cancer in a sub group of patients with PSA levels <10ng/ml: Results in first set of biopsies In: Eric AK. The 32nd Congress of the Société Internationale d'Urologie 2012 Oct; Fukuoka, Japan. Canada: Urology; 2012 [cited 2012]. p. S284. Available from: http://www.siucongress.org/eipdf/siu2012Abstract01510.pdf.
  16. 16.0 16.1 16.2 16.3 16.4 Miyake H, Kurahashi T, Muramaki M, Yamanak K, Hara I. Significance of routine transition zone biopsies in Japanese men undergoing transrectal ultrasound-guided prostate biopsies. Int J Urol 2005 Nov;12(11):964-8 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/16351652.
  17. 17.0 17.1 17.2 17.3 17.4 Moussa AS, Meshref A, Schoenfield L, Masoud A, Abdel-Rahman S, Li J, et al. Importance of additional "extreme" anterior apical needle biopsies in the initial detection of prostate cancer. Urology 2010 May;75(5):1034-9 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20080294.
  18. 18.0 18.1 Numao N, Kawakami S, Sakura M, Yoshida S, Koga F, Saito K, et al. Characteristics and clinical significance of prostate cancers missed by initial transrectal 12-core biopsy. BJU Int 2012 Mar;109(5):665-71 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21939488.
  19. 19.0 19.1 19.2 19.3 19.4 Orikasa K, Ito A, Ishidoya S, Saito S, Endo M, Arai Y. Anterior apical biopsy: is it useful for prostate cancer detection? Int J Urol 2008 Oct;15(10):900-4; discussion 904 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18657203.
  20. 20.0 20.1 20.2 20.3 20.4 20.5 Patel AR, Jones JS, Zhou M, Schoenfield L, Magi-Galluzzi C. Parasagittal biopsies are more important as part of an initial biopsy strategy than as part of a repeat biopsy strategy: observations from a unique population. Prostate Cancer Prostatic Dis 2007;10(4):352-5 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17420763.
  21. 21.0 21.1 21.2 21.3 21.4 21.5 Ploussard G, Nicolaiew N, Marchand C, Terry S, Vacherot F, Vordos D, et al. Prospective Evaluation of an Extended 21-Core Biopsy Scheme as Initial Prostate Cancer Diagnostic Strategy. Eur Urol 2014 Jan;65(1):154-61 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22698576.
  22. 22.0 22.1 22.2 22.3 22.4 Takeshita H, Numao N, Kijima T, Yokoyama M, Ishioka J, Matsuoka Y, et al. Diagnostic performance of initial transperineal 14-core prostate biopsy to detect significant cancer. Int Urol Nephrol 2013 Jun;45(3):645-52 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23529272.
  23. 23.0 23.1 23.2 23.3 23.4 Uno H, Nakano M, Ehara H, Deguchi T. Indications for extended 14-core transrectal ultrasound-guided prostate biopsy. Urology 2008 Jan;71(1):23-7 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/18242358.

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Discussion

Supporting attachments