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    A multicenter, randomized, single-blind, 2-arm intervention study evaluating the adverse events and quality of life after irreversible electroporation for the ablation of localized low-intermediate risk prostate cancer
    (NLM (Medline), 2023) de la Rosette, Jean J. M. C. H.; Dominguez-Escrig, Jose; Zhang, Kai; Teoh, Jeremy; Barret, Eric; Ramon-Borja, Juan Casanova; Muir, Gordon; Bohr, Julia; de Reijke, Theo; Ng, Chi-Fai; Leung, Chi-Ho; Sanchez-Salas, Rafael; del Pilar Laguna Pes, Maria
    PURPOSE: Our goal was to evaluate the effect of focal vs extended irreversible electroporation on side effects, patient-reported quality of life, and early oncologic control for localized low-intermediate risk prostate cancer patients. MATERIALS AND METHODS: Men with localized low-intermediate risk prostate cancer were randomized to receive focal or extended irreversible electroporation ablation. Quality of life was measured by International Index of Erectile Function, Expanded Prostate Cancer Index Composite questionnaire, and International Prostate Symptom Score. RESULTS: A total of 51 and 55 patients underwent focal and extended irreversible electroporation, respectively. The median follow-up time was 30 months. Rates of erectile dysfunction and rates of adverse events were similar between the 2 groups at 3 months. The focal ablation group seemed to have better International Index of Erectile Function scores at 3 months; it also had a better Expanded Prostate Cancer Index Composite-sexual function score than the extended ablation group across time that was close to statistical significance (mean difference 1.4; 95% CI -0.13 to 2.9, P = .073). There were no significant differences between the 2 groups in other quality-of-life measures. Upon prostate biopsy at 6 months, the rate of residual clinically significant prostate cancer (Gleason ?3 + 4) was 18.8% and 13.2% in the focal and extended irreversible electroporation groups, respectively, without significant differences. CONCLUSIONS: Focal and extended irreversible electroporation ablation had similar safety profile, urinary function, and oncologic outcomes in men with localized low-intermediate risk prostate cancer. In addition, focal ablation demonstrated superior erectile function outcome over extended irreversible electroporation in the first 3-6 months.
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    A multicenter, randomized, single-blind, 2-arm intervention study evaluating the adverse events and quality of life after irreversible electroporation for the ablation of localized low-intermediate risk prostate cancer
    (Lippincott Williams & Wilkins, 2023) de la Rosette, Jean J. M. C. H.; Dominguez-Escrig, Jose; Zhang, Kai; Teoh, Jeremy; Barret, Eric; Ramon-Borja, Juan Casanova; Muir, Gordon; Bohr, Julia; de Reijke, Theo; Ng, Chi-Fai; Leung, Chi-Ho; Sanchez-Salas, Rafael; del Pilar Laguna Pes, Maria
    Purpose: Our goal was to evaluate the effect of focal vs extended irreversible electroporation on side effects, patient-reported quality of life, and early oncologic control for localized low- intermediate risk prostate cancer patients. Materials and Methods: Men with localized low-intermediate risk prostate cancer were randomized to receive focal or extended irreversible electroporation ablation. Quality of life was measured by International Index of Erectile Function, Expanded Prostate Cancer Index Composite questionnaire, and International Prostate Symptom Score. Results: A total of 51 and 55 patients underwent focal and extended irreversible electroporation, respectively. The median follow-up time was 30 months. Rates of erectile dysfunction and rates of adverse events were similar between the 2 groups at 3 months. The focal ablation group seemed to have better International Index of Erectile Function scores at 3 months; it also had a better Expanded Prostate Cancer Index Composite-sexual function score than the extended ablation group across time that was close to statistical significance (mean difference 1.4; 95% CI -0.13 to 2.9, P [.073). There were no significant differences between the 2 groups in other quality-of-life measures. Upon prostate biopsy at 6 months, the rate of residual clinically significant prostate cancer (Gleason >= 3 D 4) was 18.8% and 13.2% in the focal and extended irreversible electroporation groups, respectively, without significant differences. Conclusions: Focal and extended irreversible electroporation ablation had similar safety profile, urinary function, and oncologic outcomes in men with localized low-intermediate risk prostate cancer. In addition, focal ablation demonstrated superior erectile function outcome over extended irreversible electroporation in the first 3-6 months.
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    Effect of focal vs extended irreversible electroporation for the ablation of localized low- or intermediate-risk prostate cancer on early oncological control: A randomized clinical trial
    (American Medical Association, 2023) Zhang, Kai; Teoh, Jeremy; del Pilar Laguna Pes, Maria; Dominguez-Escrig, Jose; Barret, Eric; Ramon-Borja, Juan Casanova; Muir, Gordon; Bohr, Julia; Pelechano Gómez, Paula; Ng, Chi-Fai; Sanchez-Salas, Rafael; de la Rosette, Jean J. M. C. H.
    Importance: Focal ablative irreversible electroporation (IRE) is a therapy that treats only the area of the tumor with the aim of achieving oncological control while reducing treatment-related functional detriment. Objective: To evaluate the effect of focal vs extended IRE on early oncological control for patients with localized low- and intermediate-risk prostate cancer. Design, Setting, and Participants: In this randomized clinical trial conducted at 5 centers in Europe, men with localized low- to intermediate-risk prostate cancer were randomized to receive either focal or extended IRE ablation. Data were collected at baseline and at regular intervals after the procedure from June 2015 to January 2020, and data were analyzed from September 2021 to July 2022. Main Outcomes and Measures: Oncological outcome as indicated by presence of clinically significant prostate cancer (International Society of Urological Pathology grade ?2) on transperineal template-mapping prostate biopsy at 6 months after IRE. Descriptive measures of results from that biopsy included the number and location of positive cores. Results: A total of 51 and 55 patients underwent focal and extended IRE, respectively. Median (IQR) age was 64 years (58-67) in the focal ablation group and 64 years (57-68) in the extended ablation group. Median (IQR) follow-up time was 30 months (24-48). Clinically significant prostate cancer was detected in 9 patients (18.8%) in the focal ablation group and 7 patients (13.2%) in the extended ablation group. There was no significant difference in presence of clinically significant prostate cancer between the 2 groups. In the focal ablation group, 17 patients (35.4%) had positive cores outside of the treated area, 3 patients (6.3%) had positive cores in the treated area, and 5 patients (10.4%) had positive cores both in and outside of the treated area. In the extended group, 10 patients (18.9%) had positive cores outside of the treated area, 9 patients (17.0%) had positive cores in the treated area, and 2 patients (3.8%) had positive cores both in and outside of the treated area. Clinically significant cancer was found in the treated area in 5 of 48 patients (10.4%) in the focal ablation group and 5 of 53 patients (9.4%) in the extended ablation group. Conclusions and Relevance: This study found that focal and extended IRE ablation achieved similar oncological outcomes in men with localized low- or intermediate-risk prostate cancer. Because some patients with intermediate-risk prostate cancer are still candidates for active surveillance, focal therapy may be a promising option for those patients with a high risk of cancer progression. Trial Registration: ClinicalTrials.gov Identifier: NCT01835977.