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The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol
INTRODUCTION: Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Abl...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4216863/ https://www.ncbi.nlm.nih.gov/pubmed/25354827 http://dx.doi.org/10.1136/bmjopen-2014-006382 |
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author | van den Bos, W de Bruin, D M Muller, B G Varkarakis, I M Karagiannis, A A Zondervan, P J Laguna Pes, M P Veelo, D P Savci Heijink, C D Engelbrecht, M R W Wijkstra, H de Reijke, T M de la Rosette, J J M C H |
author_facet | van den Bos, W de Bruin, D M Muller, B G Varkarakis, I M Karagiannis, A A Zondervan, P J Laguna Pes, M P Veelo, D P Savci Heijink, C D Engelbrecht, M R W Wijkstra, H de Reijke, T M de la Rosette, J J M C H |
author_sort | van den Bos, W |
collection | PubMed |
description | INTRODUCTION: Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer. METHODS AND ANALYSIS: In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone. ETHICS AND DISSEMINATION: The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. CONCLUSIONS: This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate tissue. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov database: NCT01790451. |
format | Online Article Text |
id | pubmed-4216863 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-42168632014-11-04 The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol van den Bos, W de Bruin, D M Muller, B G Varkarakis, I M Karagiannis, A A Zondervan, P J Laguna Pes, M P Veelo, D P Savci Heijink, C D Engelbrecht, M R W Wijkstra, H de Reijke, T M de la Rosette, J J M C H BMJ Open Urology INTRODUCTION: Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer. METHODS AND ANALYSIS: In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone. ETHICS AND DISSEMINATION: The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. CONCLUSIONS: This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate tissue. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov database: NCT01790451. BMJ Publishing Group 2014-10-29 /pmc/articles/PMC4216863/ /pubmed/25354827 http://dx.doi.org/10.1136/bmjopen-2014-006382 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Urology van den Bos, W de Bruin, D M Muller, B G Varkarakis, I M Karagiannis, A A Zondervan, P J Laguna Pes, M P Veelo, D P Savci Heijink, C D Engelbrecht, M R W Wijkstra, H de Reijke, T M de la Rosette, J J M C H The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol |
title | The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol |
title_full | The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol |
title_fullStr | The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol |
title_full_unstemmed | The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol |
title_short | The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol |
title_sort | safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol |
topic | Urology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4216863/ https://www.ncbi.nlm.nih.gov/pubmed/25354827 http://dx.doi.org/10.1136/bmjopen-2014-006382 |
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