Primary Cryoablation Nadir Prostate Specific Antigen and Biochemical Failure David A. Levy,*,† Louis L. Pisters‡ and J. Stephen Jones§ From the Department of Regional Urology, Glickman Urological and Kidney Institute, The Cleveland Clinic Foundation, Cleveland, Ohio (DAL, JSJ), and the Department of Urology, University of Texas M. D. Anderson Cancer Center, Houston, Texas (LLP) Purpose: We correlated nadir post-cryoablation prostate specific antigen with long-term biochemical disease-free survival in a risk stratified cohort of patients with prostate cancer treated with cryoablation. Materials and Methods: The records of 2,427 patients treated with cryoablation from the Cryo On-Line Data Registry were studied for biochemical disease-free survival based on nadir + 2 criteria using prostate specific antigen determina- tions out to 60 months after cryoablation. Results: For nadir prostate specific antigen less than 0.1 ng/ml, the 36, 48 and 60-month biochemical disease-free survival was 93%, 91.8% and 91.8%, respec- tively, for low risk disease; 88%, 81% and 76%, respectively, for intermediate risk; and 82%, 76% and 71%, respectively, for high risk disease. For prostate specific antigen 0.1 to 0.5 ng/ml the 36, 48 and 60-month biochemical disease-free sur- vival rates were 92%, 91.5% and 86%, respectively, for low risk; 78%, 72% and 67%, respectively, for intermediate risk; and 64%, 61% and 51%, respectively, for high risk disease. For a prostate specific antigen of 0.6 to 1.0 ng/ml the 24-month biochemical disease-free survival was 70.5% for low risk, 56.1% for intermediate risk and 46.7% for high risk disease. A prostate specific antigen of 1.1 to 2.5 ng/ml was associated with a 12-month failure rate of 29.6%, 38% and 74.8% for low, intermediate and high risk groups, respectively. Conclusions: Nadir prostate specific antigen after prostate cryoablation is prog- nostic for biochemical disease-free survival. However, by itself it cannot be used as a definition of disease-free survival since it has not been correlated with disease specific or metastasis-free survival. A prostate specific antigen of 0.6 ng/ml or greater correlated with a 29.5% biochemical failure rate at 24 months regardless of risk stratification and, therefore, these cases require close followup. Key Words: prostatic neoplasms, cryosurgery, prostate-specific antigen, treatment outcome Abbreviations and Acronyms ASTRO = American Society for Therapeutic Radiology and Oncology bDFS = biochemical disease-free survival COLD Registry = Cryo On-Line Data Registry PSA = prostate specific antigen Submitted for publication January 22, 2009. * Correspondence: Department of Regional Urology, Glickman Urological and Kidney Institute Q-10, The Cleveland Clinic Foundation, 9500 Eu- clid Ave., Cleveland, Ohio 44195 (telephone: 216- 476-7540; FAX: 216-476-7420; e-mail: Levyd3@ ccf.org). † Financial interest and/or other relationship with Endocare, Inc. ‡ Financial interest and/or other relationship with Endocare, Inc. and COLD Registry. § Financial interest and/or other relationship with Endocare Inc., Cook, Abbott and Pfizer. For another article on a related topic see page 1186. THE Cryo On-Line Data Registry pro- vides the potential for comprehensive data analysis of cryosurgical outcomes. The database is reliant on individual practitioner submission of diagnostic, procedure related and postoperative in- formation on patients treated with prostate cryoablation. Inherent in this method of data collection are limita- tions to what can be extracted from the database. We queried the database to correlate nadir PSAs with biochemical disease-free survival based on Phoenix (nadir + 2) criteria in a risk stratified population of patients treated with cryo- ablation. The COLD Registry is finan- cially supported by Endocare Inc. (Irvine, California), with all data held and man- aged through an independent company, Watermark Research Partners Inc. (Indi- anapolis, Indiana), and overseen by an independent board of physician directors. 0022-5347/09/1823-0931/0 Vol. 182, 931-937, September 2009 THE JOURNAL OF UROLOGY ® Printed in U.S.A. Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION DOI:10.1016/j.juro.2009.05.041 www.jurology.com 931