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Öğe 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, MariaPURPOSE: 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.Öğe 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, MariaPurpose: 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.Öğe 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.Öğe Focal therapy for prostate cancer: Evolutionary parallels to breast cancer treatment. Letter.(Wolters Kluwer Health, 2023) Avolio, Pier Paolo; Polascik, Thomas J.; Rastinehad, Ardeshir; de la Rosette, Jean J. M. C. H.; Sanchez-Salas, RafaelTo the Editor:We read with great interest the recentmanuscript by Labbate et al reviewing the develop-ment of focal therapy in breast and prostate cancer(PCa).1Breast focal therapy (bFT) represents a suc-cessful model for organ-sparing cancer treatment, soas urologists sensible to prostate focal therapy (pFT)we can learn much about the complex process of bFTrecognition by the scientific community.Öğe Impact of COVID-19 on medical education: Introducinghomo digitalis(Springer, 2021) Gravas, Stavros; Ahmad, Mümtaz; Hernandez-Porras, Andres; Furriel, Frederico; Alvarez-Maestro, Mario; Kumar, Anant; Lee, Kyu-Sung; Azodoh, Evaristus; Mburugu, Patrick; Sanchez-Salas, Rafael; Bolton, Damien; Gomez, Reynaldo; Klotz, Laurence; Kulkarni, Sanjay; Tanguay, Simon; Elliott, Sean; de la Rosette, Jean J. M. C. H.Purpose To determine how members of the Societe Internationale d'Urologie (SIU) are continuing their education in the time of COVID-19. Methods A survey was disseminated amongst SIU members worldwide by email. Results were analyzed to examine the influence of age, practice region and settings on continuing medical education (CME) of the respondents. Results In total, 2494 respondents completed the survey. Internet searching was the most common method of CME (76%; allps < 0.001), followed by searching journals and textbook including the online versions (62%; allps < 0.001). Overall, 6% of the respondents reported no time/interest for CME during the pandemic. Although most urologists report using only one platform for their CME (26.6%), the majority reported using >= 2 platforms, with approximately 10% of the respondents using up to 5 different platforms. Urologists < 40 years old were more likely to use online literature (69%), podcasts/AV media (38%), online CME courses/webinars (40%), and social media (39%). There were regional variations in the CME modality used but no significant difference in the number of methods by region. There was no significant difference in responses between urologists in academic/public hospitals or private practice. Conclusion During COVID-19, urologists have used web-based learning for their CME. Internet learning and literature were the top frequently cited learning methods. Younger urologists are more likely to use all forms of digital learning methods, while older urologists prefer fewer methods.Öğe Making a case "for" focal therapy of the prostate in intermediate risk prostate cancer: Current perspective and ongoing trials(Springer, 2021) Wang, Alex Z.; Lebastchi, Amir H.; O'Connor, Luke P.; Ahdoot, Michael; Mehralivand, Sherif; Yerram, Nitin; Taneja, Samir S.; George, Arvin K.; Sanchez-Salas, Rafael; Ward, John F.; del Pilar Laguna Pes, Maria; de la Rosette, Jean J. M. C. H.; Pinto, Peter A.Focal therapy is growing as an alternative management options for men with clinically localized prostate cancer. Parallel to the increasing popularity of active surveillance (AS) as a treatment for low-risk disease, there has been an increased interest towards providing focal therapy for patients with intermediate-risk disease. Focal therapy can act as a logical "middle ground" in patients who seek treatment while minimizing potential side effects of definitive whole-gland treatment. The aim of the current review is to define the rationale of focal therapy in patients with intermediate-risk prostate cancer and highlight the importance of patient selection in focal therapy candidacy.Öğe Molecular biomarkers in the context of focal therapy for prostate cancer: Recommendations of a delphi consensus from the focal therapy society(Edizioni Minerva Medica, 2022) Marra, Giancarlo; del Pilar Laguna Pes, Maria; Walz, Jochen; Pavlovich, Christian P.; Bianco, Fernando; Gregg, Justin; Lebastchi, Amir H.; Lepor, Herbert; Macek, Petr; Rais-Bahrami, Soroush; Robertson, Cary; Rukstalis, Daniel; Salomon, Georg; Ukimura, Osamu; Abreu, Andre L.; Barbe, Yann; Cathelineau, Xavier; Gandaglia, Giorgio; George, Arvin K.; Gomez Rivas, Juan; Gupta, Rajan T.; Lawrentschuk, Nathan; Kasivisvanathan, Veeru; Lomas, Derek; Malavaud, Bernard; Margolis, Daniel; Matsuoka, Yoh; Mehralivand, Sherif; Moschini, Marco; Oderda, Marco; Orabi, Hazem; Rastinehad, Ardeshir R.; Remzi, Mesut; Schulman, Ariel; Shin, Toshitaka; Shiraishi, Takumi; Sidana, Abhinav; Shoji, Sunao; Stabile, Armando; Valerio, Massimo; Tammisetti, Varaha S.; Phin Tan, Wei; van Den Bos, Willemien; Villers, Arnaud; Willemse, Peter-Paul; de la Rosette, Jean J. M. C. H.; Polascik, Thomas; Sanchez-Salas, RafaelBACKGROUND: Focal therapy (FT) for prostate cancer (PCa) is promising. However, long-term oncological results are awaited and there is no consensus on follow-up strategies. Molecular biomarkers (MB) may be useful in selecting, treating and following up men undergoing FT, though there is limited evidence in this field to guide practice. We aimed to conduct a consensus meeting, endorsed by the Focal Therapy Society, amongst a large group of experts, to understand the potential utility of MB in FT for localized PCa. METHODS: A 38-item questionnaire was built following a literature search. The authors then performed three rounds of a Delphi Consensus using DelphiManager, using the GRADE grid scoring system, followed by a face-to-face expert meeting. Three areas of interest were identified and covered concerning MB for FT, 1) the current/present role; 2) the potential/future role; 3) the recommended features for future studies. Consensus was defined using a 70% agreement threshold. RESULTS: Of 95 invited experts, 42 (44.2%) completed the three Delphi rounds. Twenty-four items reached a consensus and they were then approved at the meeting involving (N.=15) experts. Fourteen items reached a consensus on uncertainty, or they did not reach a consensus. They were re-discussed, resulting in a consensus (N.=3), a consensus on a partial agreement (N.=1), and a consensus on uncertainty (N.=10). A final list of statements were derived from the approved and discussed items, with the addition of three generated statements, to provide guidance regarding MB in the context of FT for localized PCa. Research efforts in this field should be considered a priority. CONCLUSIONS: The present study detailed an initial consensus on the use of MB in FT for PCa. This is until evidence becomes available on the subject.Öğe Prostate cancer multifocality, the index lesion, and the microenvironment(Lippincott Williams & Wilkins, 2018) Tourinho-Barbosa, Rafael Rocha; de la Rosette, Jean J. M. C. H.; Sanchez-Salas, RafaelPurpose of reviewMost of focal therapies has addressed index lesion as the targeted tumour focus to treat localized prostate cancer (PCa), a multifocal disease. The interaction between tumour foci and host cells creates a tumour microenvironment (TME) which affects tumour growth, cellular proliferation, and PCa progression. This review aims to better understand the biology of cancer foci and their interaction with the prostatic microenvironment after focal therapy.Recent findingsIndex lesions are representative of PCa grade in low-risk patients, but the other foci of tumour, the satellite lesions, gain relevance in higher risk patients. Multiparametric MRI, guided biopsies and new biomarkers in combination are important to address PCa multifocality and to adequately select patients to focal therapy. Stromal, immune, and tumoural components are integrated in tumourigenesis and modified after the inflammation induced by focal therapy.SummaryTME and inflammation play an important role in PCa progression, but further researches are necessary to understand how once protective components of prostate microenvironment become protumour elements and how inflammation induced by focal therapy can affect them. Learning how to modulate TME is an exploratory molecular field that can lead us to better manage PCa in both prevention and treatment scenarios.Öğe Standardized nomenclature and surveillance methodologies after focal therapy and partial gland ablation for localized prostate cancer: An international multidisciplinary consensus(Elsevier, 2020) Lebastchi, Amir H.; George, Arvin Koruthu; Polascik, Thomas J.; Coleman, Jonathan; de la Rosette, Jean J. M. C. H.; Türkbey, Barış; Wood, Bradford J.; Gorin, Michael A.; Sidana, Abhinav; Ghai, Sangeet; Tay, Kae Jack; Ward, John; Sanchez-Salas, Rafael; Muller, Berrend G.; Malavaud, Bernard; Mozer, Pierre; Crouzet, Sebastien; Choyke, Peter L.; Ukimura, Osamu; Rastinehad, Ardeshir R.; Pinto, Peter A.Background: Focal therapy (FT) and partial gland ablation (PGA) are quickly adopted by urologists and radiologists as an option for the management of localized prostate cancer.Objective: To find consensus on a standardized nomenclature and to define a follow-up guideline after FT and PGA for localized prostate cancer in clinical practice.Design, setting, and participants: A review of the literature identified controversial topics in the field of FT. Online questionnaires were distributed to experts during three rounds, with the goal to achieve consensus on debated topics. The consensus project was concluded with a face-to-face meeting in which final conclusions were formulated. Outcome measurements and statistical analysis: Controlled feedback of responses of previous rounds were summarized and returned to the participants allowing them to re-evaluate their decisions. The level of agreement to achieve consensus on a topic was set at 80%.Results and limitations: Sixty-five experts participated in this interdisciplinary consensus study (72% urologists; 28% radiologists). The experts propose the use of the herein standardized nomenclature for ablative procedures. After FT/PGA, the following tests should be performed to assess treatment outcomes: prostate-specific antigen (PSA), imaging, biopsies, and functional outcome assessment. Although not a reliable marker for treatment failure, PSA should be measured every 3 mo in the 1st year and every 6 mo thereafter. Magnetic resonance imaging is the preferred image modality and should be performed at 6 and 18 mo after treatment. A systematic 12-core transrectal ultrasoundguided biopsy combined with a targeted biopsy of the treated area should be performed 6-12 mo after treatment. Functional outcomes should be obtained 3-6 mo after treatment for the first time and until stability is attained.Conclusions: The panel recommends the use of the proposed nomenclature and follow-up protocols to generate reliable data supporting a broader implementation of FT as a standard of care for select patients with localized prostate cancer. Patient summary: In this report, we present expert opinion on the use of a standardized nomenclature, and surveillance methodologies after focal therapy and partial gland ablation for localized prostate cancer.Öğe Utilization of focal therapy for patients discontinuing active surveillance of prostate cancer: Recommendations of an international delphi consensus(Elsevier Science Inc, 2021) Tan, Wei Phin; Rastinehad, Ardeshir R.; Klotz, Laurence; Carroll, Peter R.; Emberton, Mark; Feller, John F.; George, Arvin K.; Gill, Inderbir S.; Gupta, Rajan T.; Katz, Aaron E.; Lebastchi, Amir H.; Marks, Leonard S.; Marra, Giancarlo; Pinto, Peter A.; Song, Daniel Y.; Sidana, Abhinav; Ward, John F.; Sanchez-Salas, Rafael; de la Rosette, Jean J. M. C. H.; Polascik, Thomas J.Background: With the advancement of imaging technology, focal therapy (FT) has been gaining acceptance for the treatment of select patients with localized prostate cancer (CaP). We aim to provide details of a formal physician consensus on the utilization of FT for patients with CaP who are discontinuing active surveillance (AS). Methods: A 3-stage Delphi consensus on CaP and FT was conducted. Consensus was defined as agreement by >= 80% of physicians. An in-person meeting was attended by 17 panelists to formulate the consensus statement. Results: Fifty-six respondents participated in this interdisciplinary consensus study (82% urologist, 16% radiologist, 2% radiation oncology). The participants confirmed that there is a role for FT in men discontinuing AS (48% strongly agree, 39% agree). The benefit of FT over radical therapy for men coming off AS is: less invasive (91%), has a greater likelihood to preserve erectile function (91%), has a greater likelihood to preserve urinary continence (91%), has fewer side effects (86%), and has early recovery post-treatment (80%). Patients will need to undergo mpMRI of the prostate and/or a saturation biopsy to determine if they are potential candidates for FT. Our limitations include respondent's biases and that the participants of this consensus may not represent the larger medical community. Conclusions: FT can be offered to men coming off AS between the age of 60 to 80 with grade group 2 localized cancer. This consensus from a multidisciplinary, multi-institutional, international expert panel provides a contemporary insight utilizing FT for CaP in select patients who are discontinuing AS.











