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Focal Therapy of Prostate Cancer Index Lesion With Irreversible Electroporation. A Prospective Study With a Median Follow-up of 3 Years

医学 前列腺癌 前列腺 活检 磁共振成像 泌尿科 癌症 前列腺特异性抗原 前列腺活检 前瞻性队列研究 放射科 外科 内科学
作者
B. Miñana,Guillermo Andrés,G. Barbas Bernardos,Xabier Ancizu Marckert,Marcos Torres Roca,Luis Labairu Huerta,Felipe Villacampa,F. Ramón de Fata,Julián Sanz‐Ortega,Marta Abengózar,Guillermo Gallardo Madueño,A. Benito Boillos,Andrés Alcázar Peral,F. Díez-Caballero Alonso
出处
期刊:The Journal of Urology [Lippincott Williams & Wilkins]
卷期号:209 (1): 261-270 被引量:12
标识
DOI:10.1097/ju.0000000000002970
摘要

No AccessJournal of UrologyNew Technologies and Techniques1 Jan 2023Focal Therapy of Prostate Cancer Index Lesion With Irreversible Electroporation. A Prospective Study With a Median Follow-up of 3 YearsThis article is commented on by the following:Editorial CommentEditorial Comment Bernardino Miñana López, Guillermo Andrés Boville, Guillermo Barbas Bernardos, Xabier Ancizu Marckert, Marcos Torres Roca, Luis Labairu Huerta, Felipe Villacampa Aubá, Fernando Ramón de Fata Chillón, Julian Sanz Ortega, Marta Abengózar Muela, Guillermo Gallardo Madueño, Alberto Benito Boíllos, Andrés Alcázar Peral, and Fernando Díez-Caballero Alonso Bernardino Miñana LópezBernardino Miñana López *Correspondence: Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Marquesado de Santa Marta, 1, 28027, Madrid , Spain telephone: +34913531920, ext. 642; FAX +34913508677; E-mail Address: [email protected] https://orcid.org/0000-0001-7745-5650 Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Guillermo Andrés BovilleGuillermo Andrés Boville Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Guillermo Barbas BernardosGuillermo Barbas Bernardos Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Xabier Ancizu MarckertXabier Ancizu Marckert Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Marcos Torres RocaMarcos Torres Roca Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Luis Labairu HuertaLuis Labairu Huerta Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Felipe Villacampa AubáFelipe Villacampa Aubá Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Fernando Ramón de Fata ChillónFernando Ramón de Fata Chillón Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Julian Sanz OrtegaJulian Sanz Ortega Pathology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Marta Abengózar MuelaMarta Abengózar Muela Pathology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Guillermo Gallardo MadueñoGuillermo Gallardo Madueño Radiology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Alberto Benito BoíllosAlberto Benito Boíllos Radiology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , Andrés Alcázar PeralAndrés Alcázar Peral Radiology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain , and Fernando Díez-Caballero AlonsoFernando Díez-Caballero Alonso Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain View All Author Informationhttps://doi.org/10.1097/JU.0000000000002970AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Our aim was to assess oncologic, safety, and quality of life–related outcomes of focal therapy with irreversible electroporation in men with localized prostate cancer. Materials and Methods: This was a single-center, phase II study. Inclusion criteria: prostate cancer International Society of Urological Pathology grade 1-2, prostate specific antigen ≤15 ng/ml, ≤cT2b. Patients were selected based on multiparametric magnetic resonance imaging and transperineal systematic and targeted magnetic resonance imaging–ultrasound fusion–guided biopsy. Ablation of index lesions with safety margin was performed. Primary end point was cancer control, defined as the absence of any biopsy-proven tumor. A control transperineal biopsy was planned at 12 months and when suspected based on prostate specific antigen and/or multiparametric magnetic resonance imaging information. Quality of life was assessed using Expanded Prostate Cancer Index Composite Urinary Continence domain, International Index of Erectile Function, and International Prostate Symptom Score. Results: From November 2014 to July 2021, 41 consecutive patients were included with a median follow-up of 36 months. Thirty patients (73%) had International Society of Urological Pathology grade 1 tumors, 10 (24%) grade 2, and 1 (2.4%) grade 3. Recurrence was observed in 16 of 41 (39%) of the whole cohort, and 16 of 33 (48.4%) who underwent biopsy. In-field recurrence was detected in 5 (15%) and out-of-field in 11 (33.3%). Ten of 41 (24.6%) including 3 of 5 (60%) with in-field recurrences had significant tumors (Gleason pattern 4-5; more than 1 core or any >5 mm involved). Median recurrence-free survival was 32 months (95% CI 6.7-57.2). Twenty-six patients (63.4%) were free from salvage treatment. All patients preserved urinary continence. Potency was maintained in 91.8%. Conclusions: Irreversible electroporation can achieve satisfactory 3-year in-field tumor control with excellent quality of life results in selected patients. References 1. Prostate cancer incidence and newly diagnosed patient profile in Spain in 2010. BJU Int. 2012; 110(11 pt B):e701-e706. Google Scholar 2. Functional and oncologic outcomes between open and robotic radical prostatectomy at 24-month follow-up in the Swedish LAPPRO trial. Eur Urol Oncol. 2018; 1(5):353-360. Google Scholar 3. Transatlantic consensus group on active surveillance and focal therapy for prostate cancer. BJU Int. 2012; 109(11):1636-1647. Google Scholar 4. . The index lesion and the origin of prostate cancer. N Engl J Med. 2009; 22361(17):1704-1706. Google Scholar 5. . Understanding the pathological features of focality, grade and tumour volume of early-stage prostate cancer as a foundation for parenchyma-sparing prostate cancer therapies: active surveillance and focal targeted therapy. BJU Int. 2011; 108(7):1074-1085. Google Scholar 6. Multiparametric magnetic resonance imaging (MRI) and MRI-transrectal ultrasound fusion biopsy for index tumor detection: correlation with radical prostatectomy specimen. Eur Urol. 2016; 70(5):846-853. Google Scholar 7. Focal therapy eligibility determined by magnetic resonance imaging/ultrasound fusion biopsy. J Urol. 2018; 199(2):453-458. Link, Google Scholar 8. Irreversible electroporation: state of the art. Onco Targets Ther. 2016; 9:2437-2446. Google Scholar 9. Numerical simulation modeling of the irreversible electroporation treatment zone for focal therapy of prostate cancer, correlation with whole-mount pathology and T2-weighted MRI sequences. Ther Adv Urol. 2019; 11:1756287219852305. Google Scholar 10. Pilot study to assess safety and clinical outcomes of irreversible electroporation for partial gland ablation in men with prostate cancer. J Urol. 2016; 196(3):883-890. Link, Google Scholar 11. Nanoknife electroporation ablation trial: a prospective development study investigating focal irreversible electroporation for localized prostate cancer. J Urol. 2017; 197(3 Pt 1):647-654. Abstract, Google Scholar 12. Focal irreversible electroporation for prostate cancer: functional outcomes and short-term oncological control. Prostate Cancer Prostatic Dis. 2016; 19(1):46-52. Google Scholar 13. Image-guided irreversible electroporation of localized prostate cancer: functional and oncologic outcomes. Radiology. 2019; 292(1):250-257. Google Scholar 14. Focal irreversible electroporation as primary treatment for localized prostate cancer. BJU Int. 2018; 121(5):716-724. Google Scholar 15. U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Version 4.0. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf Google Scholar 16. . Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240(2):205-213. Crossref, Medline, Google Scholar 17. Oncological and quality-of-life outcomes following focal irreversible electroporation as primary treatment for localised prostate cancer: a biopsy-monitored prospective cohort. Eur Urol Oncol. 2020; 3(3):283-290. Google Scholar 18. . Preliminary diagnostic accuracy of multiparametric magnetic resonance imaging to detect residual prostate cancer following focal therapy with irreversible electroporation. Eur Urol Focus. 2019; 5(4):585-591. Google Scholar 19. Image guided focal therapy for magnetic resonance imaging visible prostate cancer: defining a 3-dimensional treatment margin based on magnetic resonance imaging histology co-registration analysis. J Urol. 2015; 194(2):364-370. Link, Google Scholar Submitted January 28, 2022; accepted August 31, 2022; published September 8, 2022. Support: The study was partially funded by the CUN Prostate Center (Clínica Universidad de Navarra). Conflict of Interest: The Authors have declared that no competing interests exist. BML has received personal fees and nonfinancial support from GSK, Astellas Pharma, Werfen, and Jannsen, outside of the submitted work. Ethics Statement: This study received Institutional Review Board approval (IRB No. ESTU-0028/13/UN0021). Author Contributions: B. Miñana López was the coordinating principal investigator, underwent all irreversible electroporation procedures, and wrote manuscript drafts. B. Miñana López, G. Andrés Boville, G. Barbas Bernardos, F. Villacampa Aubá, L. Labairu Huerta, F. Ramón de Fata Chillón, X. Ancizu Marckert, and M. Torres Roca accrued patients and collected data. B. Miñana López, G. Andrés Boville, G. Barbas Bernardos, F. Villacampa Aubá, F. Ramón de Fata Chillón, X. Ancizu Marckert, M. Torres Roca, and F. Díez-Caballero Alonso performed the transperineal MRI-ultrasound fusion–guided biopsies. J. Sanz Ortega and M. Abengozar Muela reviewed pathology samples. G. Gallardo Madueño, A. Alcázar Peral, and A. Benito Boíllos reviewed diagnostic and control multiparametric MRIs. All Authors contributed to writing and approval of this report. Data Availability: Research data are stored in an institutional repository under dedicated institutional review board. Requests for specific analyses or data will be considered by the Executive Board of CUN prostate Center following publication of the manuscript for researchers who provide a methodologically sound proposal. Data include (1) access to all the individual participant data collected during the trial, after de-identification; and (2) the study protocol, statistical analysis plan, and analytic code. Proposal should be directed to [email protected].es. To gain access, data requestors will sign a data access agreement. © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited bySiemens D (2022) This Month in Adult UrologyJournal of Urology, VOL. 209, NO. 1, (1-2), Online publication date: 1-Jan-2023.Related articlesJournal of Urology6 Oct 2022Editorial CommentJournal of Urology6 Oct 2022Editorial Comment Volume 209Issue 1January 2023Page: 261-270Supplementary Materials PEER REVIEW REPORT Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.Keywordsmultiparametric magnetic resonance imagingelectroporationprostatic neoplasmsimage-guided biopsyMetricsAuthor Information Bernardino Miñana López Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain *Correspondence: Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Marquesado de Santa Marta, 1, 28027, Madrid , Spain telephone: +34913531920, ext. 642; FAX +34913508677; E-mail Address: [email protected] More articles by this author Guillermo Andrés Boville Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Guillermo Barbas Bernardos Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Xabier Ancizu Marckert Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Marcos Torres Roca Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Luis Labairu Huerta Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Felipe Villacampa Aubá Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Fernando Ramón de Fata Chillón Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Julian Sanz Ortega Pathology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Marta Abengózar Muela Pathology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Guillermo Gallardo Madueño Radiology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Alberto Benito Boíllos Radiology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Andrés Alcázar Peral Radiology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Fernando Díez-Caballero Alonso Urology Department, CUN Prostate Center, Clínica Universidad de Navarra, Madrid, Spain More articles by this author Expand All Submitted January 28, 2022; accepted August 31, 2022; published September 8, 2022. Support: The study was partially funded by the CUN Prostate Center (Clínica Universidad de Navarra). Conflict of Interest: The Authors have declared that no competing interests exist. BML has received personal fees and nonfinancial support from GSK, Astellas Pharma, Werfen, and Jannsen, outside of the submitted work. Ethics Statement: This study received Institutional Review Board approval (IRB No. ESTU-0028/13/UN0021). Author Contributions: B. Miñana López was the coordinating principal investigator, underwent all irreversible electroporation procedures, and wrote manuscript drafts. B. Miñana López, G. Andrés Boville, G. Barbas Bernardos, F. Villacampa Aubá, L. Labairu Huerta, F. Ramón de Fata Chillón, X. Ancizu Marckert, and M. Torres Roca accrued patients and collected data. B. Miñana López, G. Andrés Boville, G. Barbas Bernardos, F. Villacampa Aubá, F. Ramón de Fata Chillón, X. Ancizu Marckert, M. Torres Roca, and F. Díez-Caballero Alonso performed the transperineal MRI-ultrasound fusion–guided biopsies. J. Sanz Ortega and M. Abengozar Muela reviewed pathology samples. G. Gallardo Madueño, A. Alcázar Peral, and A. Benito Boíllos reviewed diagnostic and control multiparametric MRIs. All Authors contributed to writing and approval of this report. Data Availability: Research data are stored in an institutional repository under dedicated institutional review board. Requests for specific analyses or data will be considered by the Executive Board of CUN prostate Center following publication of the manuscript for researchers who provide a methodologically sound proposal. Data include (1) access to all the individual participant data collected during the trial, after de-identification; and (2) the study protocol, statistical analysis plan, and analytic code. Proposal should be directed to E-mail Address: [email protected]. To gain access, data requestors will sign a data access agreement. 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