Cargando…

Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial

BACKGROUND: Current surgical and ablative treatment options for prostate cancer (PCa) may result in a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects are due to procedure related effects on adjacent structures including blood vessels, bowel, u...

Descripción completa

Detalles Bibliográficos
Autores principales: Scheltema, Matthijs J. V., van den Bos, Willemien, de Bruin, Daniel M., Wijkstra, Hessel, Laguna, M. Pilar, de Reijke, Theo M., de la Rosette, Jean JMCH
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4858903/
https://www.ncbi.nlm.nih.gov/pubmed/27150293
http://dx.doi.org/10.1186/s12885-016-2332-z
_version_ 1782430879470059520
author Scheltema, Matthijs J. V.
van den Bos, Willemien
de Bruin, Daniel M.
Wijkstra, Hessel
Laguna, M. Pilar
de Reijke, Theo M.
de la Rosette, Jean JMCH
author_facet Scheltema, Matthijs J. V.
van den Bos, Willemien
de Bruin, Daniel M.
Wijkstra, Hessel
Laguna, M. Pilar
de Reijke, Theo M.
de la Rosette, Jean JMCH
author_sort Scheltema, Matthijs J. V.
collection PubMed
description BACKGROUND: Current surgical and ablative treatment options for prostate cancer (PCa) may result in a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects are due to procedure related effects on adjacent structures including blood vessels, bowel, urethra and/or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective and safe in destroying PCa cells and also has the potential advantage of sparing surrounding tissue and vital structures, resulting in less impaired functional outcomes and maintaining men’s quality of life. METHODS/DESIGN: In this randomized controlled trial (RCT) on IRE in localized PCa, 200 patients with organ-confined, unilateral (T1c-T2b) low- to intermediate-risk PCa (Gleason sum score 6 and 7) on transperineal template-mapping biopsies (TTMB) will be included. Patients will be randomized into focal or extended ablation of cancer foci with IRE. Oncological efficacy will be determined by multiparametric Magnetic Resonance Imaging, Contrast-Enhanced Ultrasound imaging if available, TTMP and Prostate Specific Antigen (PSA) follow-up. Patients will be evaluated up to 5 years on functional outcomes and quality of life with the use of standardized questionnaires. DISCUSSION: There is critical need of larger, standardized RCTs evaluating long-term oncological and functional outcomes before introducing IRE and other focal therapy modalities as an accepted and safe therapeutic option for PCa. This RCT will provide important short- and long-term data and elucidates the differences between focal or extended ablation of localized, unilateral low- to intermediate-risk PCa with IRE. TRIAL REGISTRATION: Clinicaltrials.gov database registration number NCT01835977. The Dutch Central Committee on Research Involving Human Subjects registration number NL50791.018.14.
format Online
Article
Text
id pubmed-4858903
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-48589032016-05-07 Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial Scheltema, Matthijs J. V. van den Bos, Willemien de Bruin, Daniel M. Wijkstra, Hessel Laguna, M. Pilar de Reijke, Theo M. de la Rosette, Jean JMCH BMC Cancer Study Protocol BACKGROUND: Current surgical and ablative treatment options for prostate cancer (PCa) may result in a high incidence of (temporary) incontinence, erectile dysfunction and/or bowel damage. These side effects are due to procedure related effects on adjacent structures including blood vessels, bowel, urethra and/or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective and safe in destroying PCa cells and also has the potential advantage of sparing surrounding tissue and vital structures, resulting in less impaired functional outcomes and maintaining men’s quality of life. METHODS/DESIGN: In this randomized controlled trial (RCT) on IRE in localized PCa, 200 patients with organ-confined, unilateral (T1c-T2b) low- to intermediate-risk PCa (Gleason sum score 6 and 7) on transperineal template-mapping biopsies (TTMB) will be included. Patients will be randomized into focal or extended ablation of cancer foci with IRE. Oncological efficacy will be determined by multiparametric Magnetic Resonance Imaging, Contrast-Enhanced Ultrasound imaging if available, TTMP and Prostate Specific Antigen (PSA) follow-up. Patients will be evaluated up to 5 years on functional outcomes and quality of life with the use of standardized questionnaires. DISCUSSION: There is critical need of larger, standardized RCTs evaluating long-term oncological and functional outcomes before introducing IRE and other focal therapy modalities as an accepted and safe therapeutic option for PCa. This RCT will provide important short- and long-term data and elucidates the differences between focal or extended ablation of localized, unilateral low- to intermediate-risk PCa with IRE. TRIAL REGISTRATION: Clinicaltrials.gov database registration number NCT01835977. The Dutch Central Committee on Research Involving Human Subjects registration number NL50791.018.14. BioMed Central 2016-05-05 /pmc/articles/PMC4858903/ /pubmed/27150293 http://dx.doi.org/10.1186/s12885-016-2332-z Text en © Scheltema et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Scheltema, Matthijs J. V.
van den Bos, Willemien
de Bruin, Daniel M.
Wijkstra, Hessel
Laguna, M. Pilar
de Reijke, Theo M.
de la Rosette, Jean JMCH
Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial
title Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial
title_full Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial
title_fullStr Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial
title_full_unstemmed Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial
title_short Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial
title_sort focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4858903/
https://www.ncbi.nlm.nih.gov/pubmed/27150293
http://dx.doi.org/10.1186/s12885-016-2332-z
work_keys_str_mv AT scheltemamatthijsjv focalvsextendedablationinlocalizedprostatecancerwithirreversibleelectroporationamulticenterrandomizedcontrolledtrial
AT vandenboswillemien focalvsextendedablationinlocalizedprostatecancerwithirreversibleelectroporationamulticenterrandomizedcontrolledtrial
AT debruindanielm focalvsextendedablationinlocalizedprostatecancerwithirreversibleelectroporationamulticenterrandomizedcontrolledtrial
AT wijkstrahessel focalvsextendedablationinlocalizedprostatecancerwithirreversibleelectroporationamulticenterrandomizedcontrolledtrial
AT lagunampilar focalvsextendedablationinlocalizedprostatecancerwithirreversibleelectroporationamulticenterrandomizedcontrolledtrial
AT dereijketheom focalvsextendedablationinlocalizedprostatecancerwithirreversibleelectroporationamulticenterrandomizedcontrolledtrial
AT delarosettejeanjmch focalvsextendedablationinlocalizedprostatecancerwithirreversibleelectroporationamulticenterrandomizedcontrolledtrial