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Clinical Research

Initial assessment of safety and clinical feasibility of irreversible electroporation in the focal treatment of prostate cancer

Abstract

Background:

To evaluate the safety and clinical feasibility of focal irreversible electroporation (IRE) of the prostate.

Methods:

We assessed the toxicity profile and functional outcomes of consecutive patients undergoing focal IRE for localised prostate cancer in two centres. Eligibility was assessed by multi-parametric magnetic resonance imaging (mpMRI) and targeted and/or template biopsy. IRE was delivered under transrectal ultrasound guidance with two to six electrodes positioned transperineally within the cancer lesion. Complications were recorded and scored accordingly to the NCI Common Terminology Criteria for Adverse Events; the functional outcome was physician reported in all patients with at least 6 months follow-up. A contrast-enhanced MRI 1 week after the procedure was carried out to assess treatment effect with a further mpMRI at 6 months to rule out evidence of residual visible cancer.

Results:

Overall, 34 patients with a mean age of 65 years (s.d.=±6) and a median PSA of 6.1 ng ml−1 (interquartile range (IQR)= 4.3–7.7) were included. Nine (26%), 24 (71%) and 1 (3%) men had low, intermediate and high risk disease, respectively (D’Amico criteria). After a median follow-up of 6 months (range 1–24), 12 grade 1 and 10 grade 2 complications occurred. No patient had grade >/= 3 complication. From a functional point of view, 100% (24/24) patients were continent and potency was preserved in 95% (19/20) men potent before treatment. The volume of ablation was a median 12 ml (IQR=5.6–14.5 ml) with the median PSA after 6 months of 3.4 ng ml−1 (IQR=1.9–4.8 ng ml−1). MpMRI showed suspicious residual disease in six patients, of whom four (17%) underwent another form of local treatment.

Conclusions:

Focal IRE has a low toxicity profile with encouraging genito-urinary functional outcomes. Further prospective development studies are needed to confirm the functional outcomes and to explore the oncological potential.

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Acknowledgements

The SICPA foundation supports the ongoing fellowship and PhD programme of M. Valerio. M. Emberton and H.U. Ahmed acknowledge funding from the Medical Research Council (UK), the Pelican Cancer Foundation charity, Prostate Cancer UK, St Peters Trust charity, Prostate Cancer Research Centre, the Wellcome Trust, National Institute of Health Research-Health Technology Assessment programme, and the US National Institute of Health-National Cancer Institute. M. Emberton receives funding in part from the UK National Institute of Health Research UCLH/UCL Comprehensive Biomedical Research Centre.

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Correspondence to M Valerio.

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Competing interests

M. Valerio has received funding for conference attendance from Geoscan Medical. M. Emberton and H.U. Ahmed receive funding from USHIFU, GSK, AngioDynamics and Advanced Medical Diagnostics for clinical trials. M. Emberton is a paid consultant to AngioDynamics, Steba Biotech and SonaCare Medical (previously called USHIFU). Both have previously received consultancy payments from Oncura/GE Healthcare and Steba Biotech. L. Dickinson has received trial funding support from SonaCare Medical and consultancy fees from SonaCare Medical and Oncura. None of these sources had any input whatsoever into this article. The remaining authors declare no conflicts of interest.

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Valerio, M., Stricker, P., Ahmed, H. et al. Initial assessment of safety and clinical feasibility of irreversible electroporation in the focal treatment of prostate cancer. Prostate Cancer Prostatic Dis 17, 343–347 (2014). https://doi.org/10.1038/pcan.2014.33

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