Nanoknife Electroporation Ablation Trial: A Prospective Development Study Investigating Focal Irreversible Electroporation for Localized Prostate Cancer.

Details

Serval ID
serval:BIB_93F05364D7E4
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Nanoknife Electroporation Ablation Trial: A Prospective Development Study Investigating Focal Irreversible Electroporation for Localized Prostate Cancer.
Journal
The Journal of urology
Author(s)
Valerio M., Dickinson L., Ali A., Ramachadran N., Donaldson I., Mccartan N., Freeman A., Ahmed H.U., Emberton M.
ISSN
1527-3792 (Electronic)
ISSN-L
0022-5347
Publication state
Published
Issued date
03/2017
Peer-reviewed
Oui
Volume
197
Number
3 Pt 1
Pages
647-654
Language
english
Notes
Publication types: Clinical Trial ; Journal Article
Publication Status: ppublish
Abstract
Irreversible electroporation has attractive attributes for focal ablation, namely nonthermal effect, precise demarcation of treatment and tissue selectivity. We report a prospective development study investigating focal irreversible electroporation.
A total of 20 men with certain characteristics were recruited for study, including a visible index lesion on anterior magnetic resonance imaging that was concordant with transperineal targeted and template prostate mapping biopsy, absent clinically significant disease noted elsewhere (University College London definition 2) and prostate specific antigen 15 ng/ml or less. Our primary objective was to determine the side effect profile at 12 months. Secondary objectives included the domain specific toxicity profile using patient reported outcomes and early disease control using magnetic resonance imaging targeted biopsy.
A total of 19 patients with median age of 60 years (IQR 53-66) and median prostate specific antigen 7.75 ng/ml (IQR 5.5-10.03) were treated. Of the patients 16 were available for estimating the first outcome as 1 was lost to followup and 2 had received another form of treatment by study end. All 16 men had pad-free/leak-free continence at 12 months. The proportion of men with erection sufficient for penetration decreased from 12 of 16 (75%) to 11 of 16 (69%). No serious adverse events were recorded. There was a statistically significant improvement in urinary symptoms according to changes in UCLA-EPIC (UCLA Expanded Prostate Cancer Index Composite) and I-PSS (International Prostate Symptom Score) (p = 0.039 and 0.001, respectively). Erectile function remained stable according to the change in IIEF-15 (15-Item International Index of Erectile Function) (p = 0.572). Median prostate specific antigen significantly decreased to 1.71 ng/ml (p = 0.001). One man refused followup biopsy. No residual disease was found in 11 patients (61.1%). One man (5.6%) harbored clinically insignificant disease and the remaining 6 (33.3%) harbored clinically significant disease.
Focal irreversible electroporation has low genitourinary toxicity. Additional studies are needed to optimize patient selection and treatment parameters.
Keywords
Ablation Techniques, Aged, Electroporation, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Patient Reported Outcome Measures, Prospective Studies, Prostate-Specific Antigen, Prostatic Neoplasms/diagnostic imaging, Prostatic Neoplasms/pathology, Prostatic Neoplasms/surgery, biomedical, electroporation, prostatic neoplasms, questionnaires, technology assessment, toxicity
Pubmed
Web of science
Create date
11/10/2016 16:42
Last modification date
20/08/2019 14:56
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