Saturation Biopsy for Diagnosis and Staging of Prostate Cancer
DESCRIPTION
Saturation biopsy involves obtaining at least 20 biopsy tissue cores from the prostate in a systematic manner. This procedure has been proposed for use in the diagnosis (for initial or repeat biopsy), staging, and management of patients with prostate cancer. While saturation biopsy can also be performed in an office-based setting, some perform this approach with general anesthesia.
Prostate cancer is a common cancer and is the second leading cause of cancer-related deaths in men in the U.S. The diagnosis of prostate cancer is made by biopsy of the prostate gland. The approach to biopsy has changed over time, especially with the advent of PSA (prostate-specific antigen) screening programs. There is disagreement about the optimal strategy of biopsies for the diagnosis of prostate cancer. Predominately it is agreed by the NCCN and common practice that initial prostate biopsy strategies should include at least 10-14 cores. Additional concerns have been raised about drawing conclusions about the stage (grade) of prostate cancer based on limited biopsy material. Use of multiple biopsies has also been discussed as an approach to identify tumors that may be eligible for subtotal cryoablation therapy.
POLICY
Saturation biopsy for the diagnosis, staging, and management of prostate cancer is considered investigational.
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ADDITIONAL INFORMATION
During the early 1990s, use of sextant biopsies involving six random, evenly distributed biopsies became the standard approach to the diagnosis of prostate cancer. In the late 1990s, as studies showed high false-negative rates for this strategy (missed cancers), approaches were developed to increase the total number of biopsies and to change the location of the biopsies.
The National Comprehensive Cancer Network (NCCN) addresses the use of the commonly used scheme of biopsies with the twelve core procedure with the standard sextant as well as a lateral sextant scheme that has been validated in a 2000 patient study.
There is minimal literature that demonstrates the efficacy and safety of using saturation biopsy in the staging and management of prostate cancer. The current studies do not confirm improved treatment options, or health outcomes with the use of saturation biopsy over conservative biopsy procedures for diagnosis, staging and management of prostate cancer.
SOURCES
American Urological Association. (2011). Prostate cancer. Guideline for the management of clinically localized prostate cancer: 2007 update. Retrieved October 20, 2011 from http://www.auanet.org/content/clinical-practice-guidelines/clinical-guidelines/main-reports/proscan07/content.pdf.
Ashley, R., Inman, B., Routh, J., Mynderse, L., Gettman, M., & Blute, M. (2007). Reassessing the diagnostic yield of saturation biopsy of the prostate. European Urology, 53 (5), 976-981. (Level 1 Evidence - Independent study)
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2011). Saturation biopsy for diagnosis and staging of prostate cancer. (7.01.121). Retrieved November 18, 2011 from BlueWeb. (7 articles and/ or guidelines reviewed)
Delongchamps, N. B., De La Roza, G., Jones, R., Jumbelic, M., & Haas, G. P. (2009). Saturation biopsies on autopsied prostates for detecting and characterizing prostate cancer. BJU International, 103 (1), 49-54. (Level 4 Evidence - Independent study)
Delongchamps, N., & Haas, G. (2009). Saturation biopsies for prostate cancer: Current uses and future prospects. Nature Reviews, 6 (12), 645-652.
Falzarano, S. M., Zhou, M., Hernandez, A. V., Moussa, A. S., Jones, J. S., & Magi-Galluzi, C. (2010). Can saturation biopsy predict prostate cancer localization in radical prostatectomy specimens: A correlative study and implications for focal therapy. Urology, 76 (3), 682-687. (Level 3 Evidence - Independent study)
Lowrance, W., & Scardino, P. (2009). Predictive models for newly diagnosed prostate cancer patients. Reviews in Urology, 11 (3), 117-126.
National Cancer Institute. (2011, October). Prostate cancer screening (PDQ®) health professional version. Retrieved October 20, 2011 from http://www.cancer.gov/cancertopics/pdq/screening/prostate/healthprofessional/allpages/print.
National Comprehensive Cancer Network. (2011, June). NCCN clinical practice guidelines in oncology. Prostate cancer - V.4.2011. Retrieved October 20, 2011 from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
National Comprehensive Cancer Network. (2011, June). NCCN clinical practice guidelines in oncology. Prostate cancer early detection - V.1.2011. Retrieved December 4, 2009 from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
National Guideline Clearinghouse. (2008 February). Prostate cancer. Diagnosis and treatment. Retrieved December 4, 2009 from http://www.guideline.gov.
National Guideline Clearinghouse. (2007 July). Prostate cancer. Retrieved December 4, 2009 from http://www.guideline.gov.
National Institute for Health and Clinical Excellence (NICE). (2008, February). Prostate cancer: Diagnosis and treatment. Retrieved December 4, 2009 fromhttp://www.nice.org.uk/nicemedia/live/11924/39626/39626.pdf.
Sartor, A., Hricak, H., Wheeler, T., Coleman, J., Penson, D., Carroll, P., et al. (2008). Evaluating localized prostate cancer and identifying candidates for focal therapy. Urology, 72 (6 Supplement), S12-24.
Shariat, S., & Roehrborn, C. (2008). Using biopsy to detect prostate cancer. Reviews in Urology, 10 (4), 262-280.
Simon, J., Kuefer, R., Bartsch, G., Volkmer, B., Haufmann, R., & Gottfried, H. (2008). Intensifying the saturation biopsy technique for detecting prostate cancer after previous negative biopsies: A step in the wrong direction. BJU International, 102 (4), 459-462. (Level 4 Evidence - Independent study)
Winifred S. Hayes, Inc. Medical Technology Directory. (2010, July). Prostate saturation biopsy for diagnosis of prostate cancer. Retrieved October 20, 2011 from www.Hayesinc.com/subscribers. (42 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 5/8/2010
MOST RECENT REVIEW DATE: 12/8/2011
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