A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol

IntroductionThe classical pathway for the therapy of low- to intermediate-risk localized prostate cancer is radical prostatectomy or radiation therapy, which has shown a high incidence of complications, including erectile dysfunction, urinary incontinence, and bowel injury. An alternative pathway is...

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Autores principales:	Bi-Ming He, Wei Xue, Wei-Gang Yan, Lei Yin, Bai-Jun Dong, Zhi-En Zhou, Heng-Zhi Lin, Yi Zhou, Yan-Qing Wang, Zhen-Kai Shi, Hai Zhou, Shuai-Dong Wang, Shan-Cheng Ren, Xu Gao, Lin-hui Wang, Chuan-Liang Xu, Hai-Feng Wang
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	H-FIRE = High-frequency irreversible electroporation prostate cancer multicenter analysis clinical trial protocol Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/cdb6bf7848f34192ac1578b170efa716
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spelling	oai:doaj.org-article:cdb6bf7848f34192ac1578b170efa7162021-11-10T08:10:42ZA Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol2234-943X10.3389/fonc.2021.760003https://doaj.org/article/cdb6bf7848f34192ac1578b170efa7162021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fonc.2021.760003/fullhttps://doaj.org/toc/2234-943XIntroductionThe classical pathway for the therapy of low- to intermediate-risk localized prostate cancer is radical prostatectomy or radiation therapy, which has shown a high incidence of complications, including erectile dysfunction, urinary incontinence, and bowel injury. An alternative pathway is to perform an ablation by some energy to the localized lesion, known as focal therapy. High-frequency irreversible electroporation (H-FIRE) is nonthermal energy that can be used in cancer ablation to deliver pulsed high-voltage but low-energy electric current to the cell membrane and to invoke cell death. An H-FIRE pathway has been reported to be tissue-selective, which leads to fewer side effects.Methods and AnalysisThis is a multicenter and single-arm objective performance criteria (OPC) study, in which all men with localized prostate cancer are allocated to H-FIRE ablation. This trial will assess the efficacy and safety of the H-FIRE ablation for prostate cancer. Efficacy will be assessed by prostate biopsy 6 months after treatment while safety will be assessed by adverse event reports and questionnaires. The main inclusion criteria are moderate to low-risk prostate cancer in NCCN risk classification and had no previous therapy for prostate cancer. A sample size of 110 participants is required. The primary objective is to determine whether the detection rate of clinically significant cancer by prostate biopsy is less than 20% after the H-FIRE ablation.Ethics and DisseminationThis study has obtained ethical approval by the ethics committee of all participating centers. The results of the study will be submitted for dissemination and publication in peer-reviewed journals.ConclusionsThis multicenter single-arm objective performance criteria trial will evaluate the efficacy and safety of the use of high-frequency irreversible electroporation in treating prostate cancer.Strengths and Limitations of This StudyA comprehensive evaluation of imaging and histopathology is used to determine the effect of treatment. Questionnaires were used to assess the treatment side effects. Multicenter and pragmatic designs capacitate higher generalizability. A limitation of this trial is that the prostate biopsy as an endpoint may not be as accurate as of the specimen from prostate prostatectomy. Another limitation is the 6-month follow-up time, making this trial challenging to come to firm conclusions regarding the efficacy and safety of IRE in the long term.Clinical Trial RegistrationClinicalTrials.gov, NCT03838432Bi-Ming HeWei XueWei-Gang YanLei YinBai-Jun DongZhi-En ZhouHeng-Zhi LinYi ZhouYan-Qing WangZhen-Kai ShiHai ZhouShuai-Dong WangShan-Cheng RenXu GaoLin-hui WangChuan-Liang XuHai-Feng WangFrontiers Media S.A.articleH-FIRE = High-frequency irreversible electroporationprostate cancermulticenter analysisclinical trialprotocolNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENFrontiers in Oncology, Vol 11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	H-FIRE = High-frequency irreversible electroporation prostate cancer multicenter analysis clinical trial protocol Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	H-FIRE = High-frequency irreversible electroporation prostate cancer multicenter analysis clinical trial protocol Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Bi-Ming He Wei Xue Wei-Gang Yan Lei Yin Bai-Jun Dong Zhi-En Zhou Heng-Zhi Lin Yi Zhou Yan-Qing Wang Zhen-Kai Shi Hai Zhou Shuai-Dong Wang Shan-Cheng Ren Xu Gao Lin-hui Wang Chuan-Liang Xu Hai-Feng Wang A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol
description	IntroductionThe classical pathway for the therapy of low- to intermediate-risk localized prostate cancer is radical prostatectomy or radiation therapy, which has shown a high incidence of complications, including erectile dysfunction, urinary incontinence, and bowel injury. An alternative pathway is to perform an ablation by some energy to the localized lesion, known as focal therapy. High-frequency irreversible electroporation (H-FIRE) is nonthermal energy that can be used in cancer ablation to deliver pulsed high-voltage but low-energy electric current to the cell membrane and to invoke cell death. An H-FIRE pathway has been reported to be tissue-selective, which leads to fewer side effects.Methods and AnalysisThis is a multicenter and single-arm objective performance criteria (OPC) study, in which all men with localized prostate cancer are allocated to H-FIRE ablation. This trial will assess the efficacy and safety of the H-FIRE ablation for prostate cancer. Efficacy will be assessed by prostate biopsy 6 months after treatment while safety will be assessed by adverse event reports and questionnaires. The main inclusion criteria are moderate to low-risk prostate cancer in NCCN risk classification and had no previous therapy for prostate cancer. A sample size of 110 participants is required. The primary objective is to determine whether the detection rate of clinically significant cancer by prostate biopsy is less than 20% after the H-FIRE ablation.Ethics and DisseminationThis study has obtained ethical approval by the ethics committee of all participating centers. The results of the study will be submitted for dissemination and publication in peer-reviewed journals.ConclusionsThis multicenter single-arm objective performance criteria trial will evaluate the efficacy and safety of the use of high-frequency irreversible electroporation in treating prostate cancer.Strengths and Limitations of This StudyA comprehensive evaluation of imaging and histopathology is used to determine the effect of treatment. Questionnaires were used to assess the treatment side effects. Multicenter and pragmatic designs capacitate higher generalizability. A limitation of this trial is that the prostate biopsy as an endpoint may not be as accurate as of the specimen from prostate prostatectomy. Another limitation is the 6-month follow-up time, making this trial challenging to come to firm conclusions regarding the efficacy and safety of IRE in the long term.Clinical Trial RegistrationClinicalTrials.gov, NCT03838432
format	article
author	Bi-Ming He Wei Xue Wei-Gang Yan Lei Yin Bai-Jun Dong Zhi-En Zhou Heng-Zhi Lin Yi Zhou Yan-Qing Wang Zhen-Kai Shi Hai Zhou Shuai-Dong Wang Shan-Cheng Ren Xu Gao Lin-hui Wang Chuan-Liang Xu Hai-Feng Wang
author_facet	Bi-Ming He Wei Xue Wei-Gang Yan Lei Yin Bai-Jun Dong Zhi-En Zhou Heng-Zhi Lin Yi Zhou Yan-Qing Wang Zhen-Kai Shi Hai Zhou Shuai-Dong Wang Shan-Cheng Ren Xu Gao Lin-hui Wang Chuan-Liang Xu Hai-Feng Wang
author_sort	Bi-Ming He
title	A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol
title_short	A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol
title_full	A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol
title_fullStr	A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol
title_full_unstemmed	A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol
title_sort	multicenter single-arm objective performance criteria trial to determine the efficacy and safety of high-frequency irreversible electroporation as primary treatment for localized prostate cancer: a study protocol
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/cdb6bf7848f34192ac1578b170efa716
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A Multicenter Single-Arm Objective Performance Criteria Trial to Determine the Efficacy and Safety of High-Frequency Irreversible Electroporation as Primary Treatment for Localized Prostate Cancer: A Study Protocol

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