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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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    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, Rafael
    BACKGROUND: 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.