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Focal and Nerve Warming Cryoablation: Results from the COLD Registry
Stephen M. Scionti, MD1, Louis L. Pisters, MD2, Aaron E. Katz, MD3, Franco M. Lugnani, MD4, Bryan J. Donnelly, MD5, John C. Rewcastle, PhD5, J. Stephen Jones6.
1CryoCare Center, Hilton Head, SC, USA, 2MD Anderson Cancer Center, Houston, TX, USA, 3Columbia University, New York, NY, USA, 4Society for Cryosurgery, Trieste, Italy, 5University of Calgary, Calgary, AB, Canada, 6Cleveland Clinic, Cleveland, OH, USA.
BACKGROUND: Prostate cryoablation is associated with a high rate of post treatment erectile dysfunction. Focal cryoablation (FC) is a modification of the procedure in which only those regions known to harbor cancer are treated with aggressive freezing and uninvolved regions are spared (including a neurovascular bundle). During nerve warming cryoablation (NWC) the entire prostate is targeted for ablation and a warming probe is placed near one or both nerves to spare it from an ablative freeze injury. The objective of this study is to report the outcomes of both FC and NWC at a large number of centers, both academic and community, which have participated in the Cryo On-Line Data (COLD) Registry. To the authors’ knowledge, this is the largest report of its kind to date.
METHODS: Deidentified patient data were retrospectively collected on the secure on-line data registry. Biochemical failure defined according to the 2006 revised ASTRO definition (nadir+2). Patients underwent biopsy for rising or suspicious PSA. Incontinence was defined as any leak of urine 12 months post treatment and further stratified according to pad use. Potency was defined as the ability to vaginally penetrate and complete intercourse 12 months after therapy and was stratified according to required assistance.
RESULTS: Ten physicians participated and 240 patients were entered. Demographics and morbidities are listed in the table. KM analysis demonstrated three year actuarial biochemical disease free survival of 83.6±4.5% for FC patients and two year survival of 81.5±6.9% for NWC patients. Of those patients biopsied 3/21 (14.6%) and 1/6 (16.7%) demonstrated residual or recurrent disease following FC and NWC, respectfully. Return to intercourse data is presented in the table.
CONCLUSIONS: Potency does not appear to be well preserved after NWC compared to FC. Although the follow-up of both procedures is short they both have encouraging biochemical control and biopsy results. Long term follow-up is needed to determine the cancer control of focal cryoablation.
RETURN TO INTERCOURSE | Focal | Nerve Warming | | Return to intercourse (at 12 month) | 36/51 (70.1%) | 10/34 (29.4 %) | | Without any assistance | 17/51 (33.3 %) | 4/34 (11.8 %) | | With oral pharmaceuticals only | 16/51 (31.4 %) | 3/34 (8.9 %) |
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