Six years' experience with high-intensity focused ultrasonography for prostate cancer: oncological outcomes using the new 'Stuttgart' definition for biochemical failure

Level of Evidence 2b OBJECTIVE center dot To determine oncological outcomes after high-intensity focused ultrasonography (HIFU) treatment in patients with localized prostate cancer using a new, more accurate, definition ('Stuttgart' definition) of biochemical failure. PATIENTS AND METHODS center dot We performed a retrospective review of all patients in our centre who received first-line treatment with a second-generation AblathermTM device (EDAP-TMS, Lyon, France). center dot Oncological failure was given either by biochemical failure (prostate-specific antigen, PSA, nadir plus 1.2 g/mL) (Stuttgart definition) or the start of salvage therapy because of a persistently positive biopsy after the HIFU procedure. center dot The 5-year biochemical-free survival rate and 5-year disease-free survival rate were calculated. RESULTS center dot In total, 53 patients were included (mean age, 72.5 +/- 4.5 years, range 60-79 years; 28 low risk and 25 intermediate risk). None had undergone previous hormonal therapy. Mean +/- sd follow-up was 45.4 +/- 15.5 months (range 16-71 years). Mean (range) pre-treatment PSA was 8.5 +/- 4 (0.29-18) ng/mL. The median (range) PSA nadir value was 1 (0.01-14) ng/mL and occurred after a mean (range) of 5.09 (3-24) months. center dot Overall, 36 patients (67.9%) experienced oncological failure. center dot These included 33 cases (62.2%) of biochemical failure. A PSA nadir of < 0.2, 0.21-1.0 and > 1 ng/mL was reached in 20.8%, 30.2% and 49% of patients, respectively, and was associated with biochemical failure in 9.1%, 30.3% and 60.6%, respectively. center dot The 5-year biochemical-free survival rate and disease-free survival rate were 21.7% and 13.5%, respectively. In multivariate analysis, a PSA nadir of > 1 ng/mL was significantly associated with a risk of biochemical and oncological failure (P = 0.002 and P < 0.001). center dot Oncological failure was not associated with any risk group. center dot No patient died from prostate cancer. CONCLUSIONS center dot In our experience, AblathermTM treatment for clinically localized prostate cancer was associated with a high rate of biochemical failure as determined by the 'Stuttgart' definition, and did not achieve effective cancer control. center dot The PSA nadir value after HIFU treatment was a significant predictor of treatment failure.