Single application of high-intensity focused ultrasound (HIFU) in clinically localized prostate cancer– Late oncological results and comparative cancer control efficacy with different HIFU device generations

Purpose: To report late oncological outcomes in men with localized T1-T3 prostate cancer following single-session HIFU performed under the conception of wholegland therapy. Material and methods:This retrospective single-center study enrolled patients, who were uniformly treated by whole-gland ablation between December 2002 and September 2012.Treatment involved two generations of Ablatherm devices, the Maxis ® (A1) and the Integrated Imaging ® (A2).Outcome measures were overall survival, cancer-specific, metastasis-free, biochemical-free, and disease-free survival.Biochemical failure was assessed using PSA nadir+2 and nadir+1.2failure definitions.Disease failure was defined as positive control biopsy and/or PSA failure (nadir+2 ng/ml).Kaplan-Meier analyses were performed for survival estimates.Multivariate analysis was performed using Cox models.Results: Of 357 study patients, 146 (40.9%), 124 (34.7%) and 87 (24.4%) exhibited low-, intermediate-and high-risk disease (D´Amico), respectively.Median patient age was 70 yrs.Median follow-up was 6.5 yrs.(interquartile range, 4.3-8.9).The 10-year overall, cancer-specific and metastasis-free survival rates were 68%, 95% and 91%, respectively.The 8-year biochemical-free survival rates according to risk grouping were 93%, 76% and 48%, or 81%, 62% and 45% for nadir+2 and nadir+1.2failure definitions.The 8-year disease-free survival (DFS) rates were 76%, 49% and 42%, respectively.8-year estimates of DFS differed between the HIFU-devices A1 and A2 (54% vs. 74%, p<.001).The device generation predicted disease failure (hazard ratio .51,p= .001)independent from risk group, pre-treatment PSA level and Gleason sum.Conclusions: Success with single-session HIFU does not depend solely on tumor determinants.Ablation is more efficacious with the technically advanced A2 HIFU device.