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Cryosurgery for the Treatment of Localized Prostate Cancer

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Cryosurgery for the Treatment of Localized Prostate Cancer Best Practice Policy Statement on Cryosurgery for the Treatment of Localized Prostate Cancer Change Notice: Any information related to Prostate-Specific Antigen (PSA) in the following guideline may have been revised in the American Urological Association's (AUA) PSA Best Practice Statement: 2009 Update. In the case of any discrepency in recommen - dations between guidelines pertaining to PSA, please refer to the AUA's PSA Best Practice Statement: 2009 Update for the latest AUA recommendation regarding PSA testing. Panel Managers: Kirsten Aquino Panel Members: Judy Goldfarb Richard J. Babaian, MD, Chair Bryan Donnelly, MD, Facilitator Duke Bahn, MD AUA Staff: John G. Baust, PhD Heddy Hubbard, PhD Martin Dineen, MD Edith M. Budd David Ellis, MD Michael Folmer Aaron Katz, MD Katherine Moore Louis Pisters, MD Kadiatu Kebe Daniel Rukstalis, MD Katsuto Shinohara, MD Medical Writing Assistance: J. Brantley Thrasher, MD Diann Glickman, PharmD Abbreviations and Acronyms ......................................................................................................... 2 Part I ................................................................................................................................................ 3 Introduction ................................................................................................................................. 3 Methodology ............................................................................................................................... 4 Historical Development and Technological Advances ............................................................... 5 Scientific Background ................................................................................................................. 7 PART II ......................................................................................................................................... 11 Primary Cryosurgery ................................................................................................................. 11 Patient Selection........................................................................................................................ 11 Treatment Outcomes ................................................................................................................. 13 Biochemical Outcomes ......................................................................................................... 13 Posttreatment Biopsy Status ................................................................................................. 14 Physician Reported Complications ....................................................................................... 15 Health-related Quality of Life ............................................................................................... 19 PART III ....................................................................................................................................... 20 Salvage Cryosurgery ( ............................................................................................................... 20 Introduction ............................................................................................................................... 20 Patient Selection........................................................................................................................ 21 PSA Levels............................................................................................................................ 21 Prostate Biopsy ..................................................................................................................... 21 Metastatic Work-up .............................................................................................................. 22 Other Factors ......................................................................................................................... 23 Patient Selection Summary ................................................................................................... 23 Technical Considerations and Modifications ............................................................................ 23 Treatment Outcomes ................................................................................................................. 24 Biochemical Outcomes ......................................................................................................... 24 Physician Reported Complications ....................................................................................... 26 Health-related Quality of Life ............................................................................................... 29 Summary ................................................................................................................................... 30 PART IV ....................................................................................................................................... 30 Subtotal Prostate Cryosurgery .................................................................................................. 30 Overview Conclusions .................................................................................................................. 31 Conflict of Interest Disclosures ........................................................................................... 31 Acknowledgements and Disclaimers ............................................................................................ 32 Appendix 1. ................................................................................................................................... 34 Appendix 2. ................................................................................................................................... 36 Appendix 3. ................................................................................................................................... 37 Appendix 4. ................................................................................................................................... 38 References ..................................................................................................................................... 39 Copyright © 2008 American Urological Association Education and Research, Inc.® 1 Abbreviations and Acronyms ASTRO = American Society for Therapeutic Radiology and Oncology AUA = American Urological Association BPS = Best Practice Statement CN/P = cryoneedle/cryoprobe placement EBRT = external beam radiation therapy ED = erectile dysfunction HRQL = health-related quality of life PGC = Practice Guidelines Committee PSA = prostate-specific antigen RP = radical prostatectomy SV = seminal vesicle TRUS = transrectal ultrasound TUR = transurethral resection U. S. = United States Copyright © 2008 American Urological Association Education and Research, Inc.® 2 Part I Introduction The protracted natural history of clinically localized prostate cancer has confounded the development of a national consensus regarding the optimal treatment for this disease. In the American Urological Association’s (AUA) 2007 Guideline for the Management of Clinically Localized Prostate Cancer: 2007 Update, multiple treatment modalities are considered as options.1 This conundrum is further complicated by stage migration and lead time bias, both associated with prostate specific antigen (PSA)-based early detection strategies and the resultant increase in the detection of small volume clinically localized cancers.2 Since the majority of men currently diagnosed with prostate cancer are likely to have the disease eradicated by one of several treatment modalities, the clinical focus on health related quality of life(HRQL) associated with treatment has intensified.3 There are no published long-term data on the efficacy of cryosurgery on metastasis-free, prostate cancer-specific, or overall survival as there are with other more established forms of therapy; however, several large, single institution experiences, a pooled analysis, and several prospective evaluation studies report the efficacy and morbidity of cryosurgery of the prostate.4-7 Additionally, prostate cryosurgery has been found to result in acceptable HRQL-based outcomes with a reduced cost when compared to other local therapeutic options.8,9 Short-term PSA relapse-free survival outcomes following cryoablation of the entire prostate comparable to radiation therapy in men with intermediate- and high-risk disease have been reported.4,7,10-13 Biochemical-free survival comparisons between radical prostatectomy (RP) and other nonextirpative therapies are difficult since the definitions for success are different. The inherent treatment planning flexibility of cryosurgery lends itself to a targeted sub- total gland ablation approach for men with low-risk and/or small-volume cancers.14 Copyright © 2008 American Urological Association Education and Research, Inc.® 3 Methodology As noted in the AUA Guideline for the Management of Clinically Localized Prostate Cancer: 2007 Update1, insufficient information was available to include cryosurgery in data meta-analyses. As such, the AUA convened a Panel (Appendix 1) to develop a Best Practice Statement (BPS) addressing the use of cryosurgery for the treatment of localized prostate cancer. A BPS uses published data in concert with expert opinion, but does not employ formal meta- analysis of the literature. A Medline search was performed using the Medical Subject Headings (MeSH) index headings
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