Abstract

Study Type - Therapy (outcomes research). 2c. What's known on the subject? and What does the study add? Most elderly patient with prostate cancer undergo radiation therapy, but cryoablation has gained popularity. This study demonstrates the safety and efficiency of this new approach. • To report on the largest data set regarding outcomes for whole gland prostate cryoablation as a primary treatment of prostate cancer in older men, which we empirically defined as age >75 years. • The COLD (Cryo On-Line Data) Registry consists of case report forms with pre- and post-treatment information obtained from patients undergoing prostate cryoablation. • A total of 860 patients were stratified into low-, intermediate- and high-risk groups (D'Amico 2003 risk definitions). • Biochemical disease-free survival (bDFS) was defined according to the traditional American Society for Therapeutic Radiology and Oncology definition (3 increases) and the newer (Phoenix) definition (nadir +2). • Biopsy was performed at physician discretion but most commonly for cause if a patient had an increasing or suspicious prostate-specific antigen level (PSA). • The median age was 79 years (76-91) and the median follow-up was 16 months (4-60). • The 5-year [95% confidence interval (CI)] bDFS for the entire population using ASTRO and Phoenix definitions was 79% (4%) and 62.6% (8.3%), respectively. • Stratified by risk group, 5-year bDFS (ASTRO) was 82.4% (7.9%), 78.3% (5.8%) and 77.6% (7.7%) for low, moderate and high risk, respectively. • Using the Phoenix definition, 5-year bDFS was 74.9%± 15.3%, 61.4%± 13.2% and 58.0%± 11.9% for low-, moderate- and high-risk groups, respectively. • Incontinence was reported in eight patients (0.9%). • Whole gland cryoablation in older men maintains oncological efficacy similar to that of younger men without increased morbidity.

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