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Primary Prostate Cryoablation: Results from the COLD Registry
Stephen M. Scionti, MD1, Bryan J. Donnelly, MD2, Aaron E. Katz, MD3, Louis L. Pisters, MD4, Franco M. Lugnani, MD5, John C. Rewcastle, PhD2, J. Stephen Jones, MD6.
1CryoCare Center, Hilton Head, SC, USA, 2University of Calgary, Calgary, AB, Canada, 3Columbia University, New York, NY, USA, 4MD Anderson Cancer Center, Houston, TX, USA, 5Society for Cryosurgery, Trieste, Italy, 6Cleveland Clinic, Cleveland, OH, USA.
BACKGROUND: The use of cryoablation as an initial treatment for localized prostate cancer has increased. The objective of this study is to report the outcomes of modern cryoablation at a large number of centers, both academic and community, which have participated in the Cryo On-Line Data (COLD) Registry.
METHODS: A secure on-line database was developed consisting of case report forms designed to collect relevant pre and post treatment information for patients undergoing prostate cryoablation. Data from 1608 patients who had undergone primary cryotherapy is in the registry but this analysis includes only the 690 each of whom had a minimum 24 months of follow-up. Patients were stratified according to risk groups as follows. For low risk patients all of the following were true: PSA<10, Gleason<7 and Stage<T2b. If a patient had a PSA>20, Gleason>7, or stage T2c or greater they were considered high risk. All other patients were considered moderate risk. Biochemical failure was defined according to both the original ASTRO definition (3 rises) and the 2006 updated ASTRO definition of nadir+2. Biopsy was performed at the physician’s discretion, but most commonly if a patient had a rising or suspicious PSA.
RESULTS: The average age was 67.8±7.8 years. Pre treatment PSA was 9.7±10.2 ng/ml, the average Gleason was 6.5±1.3. Only 19.0% of patients had low risk disease, 37.7% had moderate risk disease and 43.3% had high risk. Patients were followed for 48.3±26.2 months. Five year actuarial biochemical survivals and the number of patients at risk at 5 years are reported in the table. Notably, 27 of the 157 patients (17.2%) who failed according to the 3 rises definition did not have their PSA ever rise above 0.5 ng/ml. A total of 304 underwent post treatment biopsy. Of these, 53 showed evidence of disease resulting in a positive biopsy rate for those who underwent biopsy of 17.4%. The positive biopsy rate of the entire population was 53/690 (4.9%).
CONCLUSIONS: Cryoablation, as a primary treatment for prostate cancer practiced over a wide spectrum of users provides durable biochemical and local control through five years.
5-YEAR BIOCHEMICAL SURVIVAL | ASTRO (3 rises) | ASTRO (Nadir+2) | | All (n=227) | 72.4 ± 2.0 | 78.9 ± 1.8 | | Low (n=42) | 78.4 ± 5.3 | 93.3 ± 2.5 | | Moderate (n=93) | 72.5 ± 3.6 | 84.6 ± 3.1 | | High (n=73) | 67.1 ± 3.3 | 68.2 ± 3.4 |
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