BACKGROUND: We aimed to evaluate oncological and functional outcomes of index lesion HIFU ablation with Focal-One®. MATERIALS AND METHODS: We prospectively assessed treatment-naïve men with localized prostate cancer between 2017 and 2019. Inclusion criteria were stage cT ≤ 2, ≥5 years of life expectancy, grade group ≤3. Multiparametric magnetic resonance was performed before ablation. Patients with a prostate volume of ≥80 ml underwent debulking. Treatment failure was defined as a histologically confirmed tumor that required salvage treatment or androgen deprivation therapy. RESULTS: One hundred and eighty nine patients were enrolled. Data are presented as median and Interquartile Range (IQR). Median age was 70(11) years. Median baseline PSA was 5.8(3) ng/ml. Fourteen (7.4%) patients had prostate debulking before ablation. 104 (55%) patients underwent targeted ablation, 45 (23.8%) extended targeted ablation, 31 (16.4%) hemiablation, and 9 (4.8%) extended hemiablation. Median targeted ablated volume was 14(9) ml. Ninety-three complications occurred in 63/189 (33.3%) patients within 90 days. There were 77/93 (82.8%) minor (Clavien grade 1-2) and 16/93 (17.2%) major complications (Clavien grade 3a). Thirty-nine patients suffered from genito-urinary infections (Clavien grade 2). Fifteen patients required transurethral resection of the prostate/urethrotomy for recurrent urinary retention (Clavien grade 3a). One patient developed a recto-urethral fistula (Clavien grade 3a) and two long-lasting urinary incontinence. Median PSA nadir was 2.2(2.9) ng/ml. At a median follow-up of 29(15) months, 21/177 (11.9%) patients were treatment failures, 26 on monitoring, and 26 had a further ablation. Multivariable logistic regression found that failure patients had higher PSA (7.8 vs 5.7 ng/ml,p0.001) and double PSA nadir (4.8 vs 2.0 ng/ml, p < 0.001). Higher PSA nadir correlated with a 74% higher probability of failure (OR 1.74 95% CI 1.40-2.16). Cancer in the anterior stroma increased the odds of failure of three folds (OR 3.36 95% CI 1.18-9.53). Two mixed effect models (one for IPSS and one for IEEF-15) were estimated and they showed that time reaches the statistical significance coefficient only for the IEEF-15, meaning that subsequent evaluations of the indicators were significantly lower at each time point. CONCLUSIONS: Index lesion HIFU ablation demonstrated satisfactory early oncological outcome but anteriorly located tumors had inadequate ablation. Urinary function was well preserved. Sexual function slightly decreased during follow-up.
BACKGROUND: We aimed to evaluate oncological and functional outcomes of index lesion HIFU ablation with Focal-One®. MATERIALS AND METHODS: We prospectively assessed treatment-naïve men with localized prostate cancer between 2017 and 2019. Inclusion criteria were stage cT ≤ 2, ≥5 years of life expectancy, grade group ≤3. Multiparametric magnetic resonance was performed before ablation. Patients with a prostate volume of ≥80 ml underwent debulking. Treatment failure was defined as a histologically confirmed tumor that required salvage treatment or androgen deprivation therapy. RESULTS: One hundred and eighty nine patients were enrolled. Data are presented as median and Interquartile Range (IQR). Median age was 70(11) years. Median baseline PSA was 5.8(3) ng/ml. Fourteen (7.4%) patients had prostate debulking before ablation. 104 (55%) patients underwent targeted ablation, 45 (23.8%) extended targeted ablation, 31 (16.4%) hemiablation, and 9 (4.8%) extended hemiablation. Median targeted ablated volume was 14(9) ml. Ninety-three complications occurred in 63/189 (33.3%) patients within 90 days. There were 77/93 (82.8%) minor (Clavien grade 1-2) and 16/93 (17.2%) major complications (Clavien grade 3a). Thirty-nine patients suffered from genito-urinary infections (Clavien grade 2). Fifteen patients required transurethral resection of the prostate/urethrotomy for recurrent urinary retention (Clavien grade 3a). One patient developed a recto-urethral fistula (Clavien grade 3a) and two long-lasting urinary incontinence. Median PSA nadir was 2.2(2.9) ng/ml. At a median follow-up of 29(15) months, 21/177 (11.9%) patients were treatment failures, 26 on monitoring, and 26 had a further ablation. Multivariable logistic regression found that failure patients had higher PSA (7.8 vs 5.7 ng/ml,p0.001) and double PSA nadir (4.8 vs 2.0 ng/ml, p < 0.001). Higher PSA nadir correlated with a 74% higher probability of failure (OR 1.74 95% CI 1.40-2.16). Cancer in the anterior stroma increased the odds of failure of three folds (OR 3.36 95% CI 1.18-9.53). Two mixed effect models (one for IPSS and one for IEEF-15) were estimated and they showed that time reaches the statistical significance coefficient only for the IEEF-15, meaning that subsequent evaluations of the indicators were significantly lower at each time point. CONCLUSIONS: Index lesion HIFU ablation demonstrated satisfactory early oncological outcome but anteriorly located tumors had inadequate ablation. Urinary function was well preserved. Sexual function slightly decreased during follow-up.