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    Established focal therapy-hifu, ire, or cryotherapy-where are we now?-a systematic review and meta-analysis
    (2025) Tay, Kae Jack; Fong, Khi Yung; Stabile, Armando; Dominguez Escrig, Jose Luis; Ukimura, Osamu; Rodriguez Sanchez, Lara; del Pilar Laguna Pes, Maria
    Introduction: Focal Therapy (FT) is a treatment option for the treatment of limited volume clinically significant prostate cancer (csPCa). We aim to systematically review outcomes of established FT modalities to assess the contemporary baseline and identify gaps in evidence that will aid in further trial and study design. Methods: We conducted a systematic review and meta-analysis of all primary studies reporting outcomes of FT using cryotherapy, high-intensity focused ultrasound (HIFU), and irreversible electroporation (IRE). We described patient inclusion criteria, selection tools, treatment parameters, and surveillance protocols, and pooled overall survival (OS), cancer-specific survival (CSS), metastasis-free survival (MFS), biochemical progression (BP), biopsy, secondary treatment, sexual, and urinary function outcomes. Composite failure was defined as salvage whole gland ablation, radical treatment, hormonal therapy or transition to watchful waiting. Synthesis: We identified 49 unique cohorts of men undergoing FT between 2008 and 2024 (21 cryotherapy, 20 HIFU, and 8 IRE). Median follow-up ranged from 6 to 63 months. Pooled OS was 98.0%, CSS 99.3%, and MFS 98.5%. Pooled BP was 9.4%/year. Biopsy was mandated post-FT within 24 months in 36/49 (73.5%) cohorts, with pooled csPCa (GG ≥ 2) rates of 22.2% overall, 8.9% infield, and 12.3% outfield. The pooled rate of secondary FT was 5.0%, radical treatment 10.5%, and composite failure 14.1%. Of 35 studies reporting sexual function, 45.7% reported a low, 48.6% moderate, and 5.7% severe impact. For 34 cohorts reporting urinary function, 97.1% reported a low impact. No differences were noted between cryotherapy, HIFU, or IRE in any of the outcomes. Conclusion: FT with cryotherapy, HIFU, and IRE is associated with good short-intermediate term oncological and functional outcomes. However, outcome reporting is heterogeneous and often incomplete. Long-term follow-up and standardized reporting are required to better define and report FT outcomes.
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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.