Oncological and functional outcome after partial prostate HIFU ablation with Focal-One®: a prospective single-center study.

Abstract

We aimed to evaluate oncological and functional outcomes of index lesion HIFU ablation with Focal-One®. 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. 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. 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.