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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.
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    Moving away from systematic biopsies: Image-guided prostate biopsy (in-bore biopsy, cognitive fusion biopsy, MRUS fusion biopsy) -literature review
    (Springer, 2021) Yamada, Yasuhiro; Ukimura, Osamu; Kaneko, Masatomo; Matsugasumi, Toru; Fujihara, Atsuko; Vourganti, Srinivas; Marks, Leonard; Sidana, Abhinav; Klotz, Laurence; Salomon, Georg; de la Rosette, Jean J. M. C. H.
    Objective To compare the detection rate of clinically significant cancer (CSCa) by magnetic resonance imaging-targeted biopsy (MRI-TB) with that by standard systematic biopsy (SB) and to evaluate the role of MRI-TB as a replacement from SB in men at clinical risk of prostate cancer. Methods The non-systematic literature was searched for peer-reviewed English-language articles using PubMed, including the prospective paired studies, where the index test was MRI-TB and the comparator text was SB. Also the randomized clinical trials (RCTs) are included if one arm was MRI-TB and another arm was SB. Results Eighteen prospective studies used both MRI-TB and TRUS-SB, and eight RCT received one of the tests for prostate cancer detection. In most prospective trials to compare MRI-TB vs. SB, there was no significant difference in any cancer detection rate; however, MRI-TB detected more men with CSCa and fewer men with CISCa than SB. Conclusion MRI-TB is superior to SB in detection of CSCa. Since some significant cancer was detected by SB only, a combination of SB with the TB technique would avoid the underdiagnosis of CSCa.
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    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.