Best Practice Statement on Cryosurgery for the Treatment of Localized Prostate Cancer Richard J. Babaian (Chair),* Bryan Donnelly (Facilitator),† Duke Bahn, John G. Baust,‡ Martin Dineen,§ David Ellis,¶ Aaron Katz, Louis Pisters,** Daniel Rukstalis, Katsuto Shinohara and J. Brantley Thrasher From the American Urological Association Education and Research, Inc. Key Words: cryosurgery, cryotherapy, freezing, prostate, prostatic neoplasms PART I Introduction The protracted natural history of clinically localized pros- tate cancer has confounded the development of a national consensus regarding the optimal treatment for this disease. In the 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 PSA-based early detection strategies and the resultant increase in the detection of small volume clinically localized cancers. 2 Since the majority of men cur- rently diagnosed with prostate cancer are likely to have the disease eradicated by one of several treatment modalities, the clinical focus on 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 pro- spective 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 pros- tate comparable to radiation therapy in men with interme- diate- and high-risk disease have been reported. 4,7,10 –13 Bio- chemical-free survival comparisons between RP and other nonextirpative therapies are difficult since the definitions for success are different. The inherent treatment planning flexibility of cryosur- gery lends itself to a targeted subtotal gland ablation ap- proach for men with low-risk and/or small-volume cancers. 14 Methodology As noted in the AUA Guideline for the Management of Clin- ically Localized Prostate Cancer: 2007 Update, 1 insufficient information was available to include cryosurgery in data meta-analyses. As such, the AUA convened a Panel to de- velop a BPS addressing the use of cryosurgery for the treat- ment 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 per- formed using the Medical Subject Headings (MeSH) index headings “prostate cancer,” and “cryosurgery,” “cryother- apy,” and “cryoablation,” from 2000 through 2008. Publica- tions were selected for review by the Panel members. The Panel formulated recommendations based on review of all material and the Panel members’ expert opinions and expe- rience which includes the treatment of several thousands of patients. Recommendations presented herein were achieved through a consensus process and may not reflect a unani- mous decision by the Panel members. Levels of evidence were assigned based on the recommendations of the U.S. Preventive Services Task Force (Appendix 1). 15 This document was submitted for peer review, and com- ments from all 19 responding physicians and researchers were considered by the Panel in making revisions. The re- vised document was submitted for a second peer review, and responses from all 21 responding physicians and researchers were considered by the Panel when making final revisions to the document. The final document was submitted to the AUA PGC and Board of Directors for approval. Funding of the Panel was provided by the AUA. Members received no remuneration for their work. Each Panel mem- ber provided a conflict of interest disclosure to the AUA. This document is being reprinted as submitted without editorial or independent peer review. This report is also available at http:// www.auanet.org/guidelines/. Requests for reprints: Guidelines Department, American Urolog- ical Association, 1000 Corporate Blvd., Linthicum, Maryland 21090. * Financial interest and/or other relationship with Endocare and Gen-Probe. † Financial interest and/or other relationship with Endocare. ‡ Financial interest and/or other relationship with Galil Medical. § Financial interest and/or other relationship with Endocare, Ab- beymoor Medical Inc., Mentor, GlaxoSmithKline, AstraZeneca, GTX, National Cancer Institute, Amgen, Oakwood Pharmaceuti- cals, Duramed, Ce3-ION, Tap Pharmaceuticals, Wilex, EDAP Phar- maceuticals, AngioDynamic, Inc., Panacea, Aeterna Zentaris, OrthoMcNeil/Johnson & Johnson and Pfizer. ¶ Financial interest and/or other relationship with Endocare.  Financial interest and/or other relationship with Galil Medical. ** Financial interest and/or other relationship with Endocare. See Editorial on page 1882. Editor’s Note: This article is the first of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 2266 and 2267. 0022-5347/08/1805-1993/0 Vol. 180, 1993-2004, November 2008 THE JOURNAL OF UROLOGY ® Printed in U.S.A. Copyright © 2008 by AMERICAN UROLOGICAL ASSOCIATION DOI:10.1016/j.juro.2008.07.108 1993