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    A multi-center international study to evaluate the safety, functional and oncological outcomes of irreversible electroporation for the ablation of prostate cancer
    (2024) Zhang, Kai; Stricker, Phillip; Löhr, Martin; Stehling, Michael; Suberville, Michel; Cussenot, Olivier; Lunelli, Luca; Ng, Chi Fai; Teoh, Jeremy; del Pilar Laguna Pes, Maria; de la Rosette, Jean J. M. C. H.
    Background: Irreversible electroporation (IRE) is a novel technique to treat localized prostate cancer with the aim of achieving oncological control while reducing related side effects. We present the outcomes of localized prostate cancer treated with IRE from a multi-center prospective registry. Methods: Men with histologically confirmed prostate cancer were recruited to receive IRE. All the patients were proposed for prostate biopsy at 1-year post-IRE ablation. The functional outcomes were measured by the International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF-5) questionnaires. The safety of IRE was graded by the treatment-related adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE). Results: 411 patients were recruited in this study from July 2015 to April 2020. The median follow-up time was 24 months (IQR 15–36). 116 patients underwent repeat prostate biopsy during 12–18 months after IRE. Clinically significant prostate cancer (Gleason ? 3 + 4) was detected in 24.1% (28/116) of the patients; any grade prostate cancers were found in 59.5% (69/116) of the patients. The IPSS score increased significantly from 7.1 to 8.2 (p = 0.015) at 3 months but decreased to 6.1 at 6 months (p = 0.017). Afterwards, the IPSS level remained stable during follow-up. The IIEF-5 score decreased at 3 months from 16.0 to 12.1 (p < 0.001) and then maintained equable afterwards. The rate of AEs was 1.8% at 3 months and then dropped to less than 1% at 6 months and remained stable until 48 months after IRE. Major AEs (Grade 3 or above) were rare. Conclusion: For men with localized prostate cancer, IRE could achieve good urinary and sexual function outcomes and a reasonable oncological result. The real-world data are consistent with earlier studies, including recently published randomized controlled studies. The long-term oncological results need further investigation and follow-up.
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    Refining partial gland ablation for localised prostate cancer: the FALCON project
    (2025) Rodriguez Sanchez, Lara; Cathelineau, Xavier; De Reijke, Theo; Stricker, Phillip; Emberton, Mark; del Pilar Laguna Pes, Maria; Sanchez Salas, Rafael
    Objectives: To provide a contemporary statement on focal therapy (FT) for localised prostate cancer (PCa) from an international and diverse group of physicians treating localised PCa, with the aim of overcoming the limitations of previous consensus statements, which were restricted to early adopters, and to offer direction regarding the various aspects of FT application that are currently not well defined. Materials and Methods: The FocAL therapy CONsensus (FALCON) project began with a 154-item online survey, developed following a steering committee discussion and literature search. Invitations to participate were extended to a large, diverse group of professionals experienced in PCa management. From 2022 to 2023, a Delphi consensus study consisting of three online rounds was conducted using the Modified Delphi method. A 1–9 Likert scale was used for the survey, which was followed by an in-person expert meeting. The threshold for achieving consensus was set at 70% agreement/disagreement. Six main aspects of FT were covered: (i) patient selection; (ii) energy source selection; (iii) treatment approach; (iv) treatment evaluation and follow-up; (v) treatment cost and accessibility; and (vi) future perspectives. Results: Of 246 initial participants, 148 (60%) completed all three rounds. Based on participant feedback, 27 new statements were added in the second round, and 33 questions related to personal expertise, for which consensus was not necessary, were excluded. After the third and final round, consensus had not been reached for 69 items. These items were discussed at the in-person meeting, resulting in a consensus of 57 additional items. Consensus was finally not reached on 12 items. Given the volume of data, the voting outcomes are summarised in this article, with a detailed breakdown presented in the form of figures and tables. Conclusions: The FALCON project delivered a significant consensus on the approach to FT for localised PCa. Additionally, it highlighted gaps in our knowledge that may provide guidance for future research.