Saturation Biopsy for Diagnosis and Staging of Prostate Cancer
DESCRIPTION
Saturation biopsy of the prostate, in which more than 20 cores are collected systematically every few millimeters across the entire prostate, is proposed as a method to improve prostate cancer detection over that of a standard 12-core biopsy. Generally, this approach is considered for high-risk individuals with previous negative biopsies when there remains a clinical suspicion of cancer. Saturation biopsy may be performed transrectally or using the transperineal approach (the latter is generally performed as a stereotactic template-guided procedure with general anesthesia).
POLICY
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.)
MEDICAL APPROPRIATENESS
Saturation biopsy (more than 20 cores) is considered medically appropriate if ALL the following are met:
At least one prior negative biopsy
Clinical suspicion of cancer (e.g., persistently elevated or rising PSA)
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
Emerging evidence suggests that saturation biopsy may be of value to help identify regions of cancer missed on prior prostate biopsies in select individuals.
SOURCES
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. (8:2023). Saturation biopsy for diagnosis, staging, and management of prostate cancer. (7.01.121). Retrieved December 4, 2023 from https://www.bcbsaoca.com/eps/. (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., & 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., & 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. (2023, September). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Prostate cancer early detection - V.2.2023. Retrieved December 4, 2023 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, September). NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®). Prostate cancer - V.4.2023. Retrieved December 4, 2023 from the National Comprehensive Cancer Network.
National Institute for Health and Care Excellence. (2019, May; last update search December 2021). Prostate cancer: diagnosis and management. Retrieved September 23, 2022 from https://www.nice.org.uk/guidance.
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)
Quintana, L., Ward, A., Gerrin, S., Genega, E.., Rosen, S., Sanda, M.G., et al. (2016). Gleason misclassification rate is independent of number of biopsy cores in systematic biopsy. Urology, 91, 143-149. (Level 4 evidence)
Winifred S. Hayes, In. Medical Technology Directory. (2020, November; last update search December 2023). Transperineal template prostate biopsy following negative transrectal biopsy. Retrieved December 5, 2023 from www.hayesin.com/subscribers. (79 articles and/or guidelines reviewed)
Zaytoun, O., Moussa, A., Gao, T., Fareed, K., & 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: 2/8/2024
ID_BT
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