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Study Type – Therapy (outcomes research)Level of Evidence 2b•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.•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).•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.•The 5-year biochemical-free survival rate and 5-year disease-free survival rate were calculated.•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.•Overall, 36 patients (67.9%) experienced oncological failure.•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.•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).•Oncological failure was not associated with any risk group.•No patient died from prostate cancer.•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.•The PSA nadir value after HIFU treatment was a significant predictor of treatment failure.