Saturation Biopsy for Diagnosis and Staging of Prostate Cancer
Prostate cancer is the second leading cause of cancer-related deaths in men in the United States. The diagnosis of prostate cancer is made by biopsy of the prostate gland. At present, many practitioners use a 12 to 14 core “extended” biopsy strategy for individuals undergoing initial biopsy. This extended biopsy is performed in an office setting and allows for more extensive sampling of the lateral peripheral zone; sampling of the lateral horn may increase the cancer detection rate by approximately 25%.
Another approach is the saturation biopsy, in which generally more than 20 cores are taken from the prostate, using a grid template, in an effort to improve sampling of the anterior zones of the gland. Saturation biopsy may be performed transrectally or using a transperineal approach.
Saturation biopsy (more than 20 cores) for the diagnosis, staging, and management of prostate cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Saturation biopsy (more than 20 cores) is considered medically appropriate if ALL of the following are met:
At least one prior negative biopsy
Clinical suspicion of cancer
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According to the 2018 National Comprehensive Cancer Network (NCCN) guideline for Prostate Cancer Early Detection emerging evidence suggests that the use of saturation biopsy may be of value to help identify regions of cancer missed on prior prostate biopsies.
American Urological Association (AUA) / American Society for Radiation Oncology (ASTRO) / Society of Urologic Oncology (SUO). (2017, April). Clinically localized prostate cancer: AUA/ASTRO/SUO guideline. Retrieved December 4, 2017 from www.auanet.org/guidelines.
BlueCross BlueShield Association. Evidence Positioning System. (7:2018). Saturation biopsy for diagnosis, staging, and management of prostate cancer. (7.01.121). Retrieved January 15, 2019 from https://www.evidencepositioningsystem.com/. (14 articles and/ or guidelines reviewed)
Jiang, X., Zhu, S., Feng, G., Zhang, Z., Li, C., Li, H., et al. (2013). Is an initial saturation prostate biopsy scheme better than an extended scheme for detection of prostate cancer? A systematic review and meta-analysis. European Urology, 63 (6), 1031-1039. Abstract retrieved March 1, 2016 from PubMed database.
Lee, M., Moussa, A., Zaytoun, O., Yu, C., and Jones, J. (2011). Using a saturation biopsy scheme increases cancer detection during repeat biopsy in men with high-grade prostatic intraepithelial neoplasia. Urology, 78 (5), 1115-9. Abstract retrieved February 26, 2018 from PubMed database.
Li, Y. H., Elshafei, A., Hatem, A., Zippe, C. D., Fareed, K., Jones, J. S. (2014). Potential benefit of transrectal saturation prostate biopsy as an initial biopsy strategy: decreased likelihood of finding significant cancer on future biopsy. Urology, 83 (4), 714-8. Abstract retrieved from PubMed database November 10, 2014.
Li, Y.H., Elshafei, A., Li, J., Gong, M., Susan, L., Fareed, K, & Jones, J.S. (2014). Transrectal saturation technique may improve cancer detection as an initial prostate biopsy strategy in men with prostate-specific antigen <10 ng/ml. European Urology, 65 (6), 1178-1183. Abstract retrieved March 1, 2016 from PubMed database.
Mabjeesh, N., Lidawi, G., Chen, J., German, L., and Matzkin, H. (2012). High detection rate of significant prostate tumours in anterior zones using transperineal ultrasound-guided template saturation biopsy. BJU International, 110 (7), 993-997. Abstract retrieved February 26, 2018 from PubMed database.
Maccagano, C., Gallina, A., Roscigno, M., Raber, M., Capitanio, U., Sacca, A., et al. (2012). Prostate saturation biopsy following a first negative biopsy: state of the art. Urologia Internationalis, 89 (2), 126-135. (Level 1 evidence)
Nakai, Y., Tanaka, N., Anai, S., Miyake, M., Hori< S., Tatsumi, Y., et al. (2017). Transperineal template-guided saturation biopsy aimed at sampling one core for each milliliter of prostate volume: 103 cases requiring repeat prostate biopsy. BMC Urology, 17 (28) e-published. (Level 4 evidence)
National Comprehensive Cancer Network. (2018, April). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Prostate cancer early detection - V.2.2018. Retrieved January 15, 2019 from the National Comprehensive Cancer Network.
Nelson, A., Harvey, R., Parker, R., Kaster, C., Doble, A., & Gnanapragasam, V. (2013). Repeat prostate biopsy strategies after initial negative biopsy: meta-regression comparing cancer detection of transperineal, transrectal saturation and MRI guided biopsy. PLOS One, 8 (2), e57480. (Level 2 evidence)
Sivaraman, A., Sanchez-Salas, R., Ahmed, H., Barret, E., Cathala, N., Mombet, A. et al. (2015). Clinical utility of transperineal template-guided mapping biopsy of the prostate after negative magnetic resonance imaging guided transrectal biopsy.Urologic Oncology, 33 (7), 329.e7-11. Abstract retrieved February 26, 2018 from PubMed database.
U.S. Preventive Services Task Force (USPSTF). Prostate cancer screening. Retrieved March 1, 2016 from http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/prostate-cancer-screening.
Zaytoun, O., Moussa, A., Gao, T., Fareed, K., and Jones, J. (2011). Office based transrectal saturation biopsy improves prostate cancer detection compared to extended biopsy in the repeat biopsy population. Journal of Urology, 186 (3), 850-854. Abstract retrieved February 26, 2018 from PubMed database.
ORIGINAL EFFECTIVE DATE: 5/8/2010
MOST RECENT REVIEW DATE: 2/14/2019
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