Electroporation Ablation Trial ( NEAT ) : a prospective development study investigating focal irreversible electroporation for localised prostate cancer
semanticscholar(2021)
摘要
Purpose Irreversible electroporation (IRE) has attractive attributes for focal ablation, namely non-thermal effect, precise demarcation of treatment, and tissue-selectivity. We report on a prospective development study investigating focal IRE. Materials and Methods 20 men with the following characteristics were recruited: anterior MR-visible index lesion concordant with transperineal targeted and template prostate mapping biopsy, absence of clinically significant disease elsewhere (UCL definition 2), and PSA = 15 ng/ml. Our primary objective was to determine the side-effect profile at 12 months. Secondary objectives included domain-specific toxicity profile using patient-reported outcomes, and early disease control using MR-targeted biopsy. Results Nineteen patients with median age at 60 years (IQR 53-66) and median PSA at 7.75 ng/ml (5.5-10.03) were treated. Sixteen patients were available for estimating first outcome as one was lost to follow up, and two had another form of treatment by study end. All men (16/16) had pad-free/leak-free continence at 12 months. The proportion of men with erections sufficient for penetration decreased from 12/16 (75%) to 11/16 (69%). No serious adverse events were recorded. There was a statistically significant improvement in urinary symptoms (UCLA-EPIC change, p=0.039; IPSS change, p=0.001). Erectile function remained stable (IIEF-15 change, p=0.572). The median PSA significantly dropped to 1.71 ng/ml (p=0.001). One man refused control biopsy. No residual disease was found in 11 patients (61.1%). One man (5.6%) harboured clinically insignificant disease; the remaining six (33.3%) harboured clinically significant disease. Conclusion Focal IRE has low genito-urinary toxicity. Additional studies are needed to optimise patient selection and treatment parameters.
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