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.

1st Faculty of Medicine Charles University Prague Czech Republic

Bashkir State Medical University Ufa Russia

Department of Clinical Oncology University College London Hospitals NHS Foundation Trust London UK

Department of Histopathology University College London Hospitals NHS Foundation Trust London UK

Department of Molecular Medicine and Surgery Karolinska Institutet Stockholm Sweden

Department of Pathology Medical University of Vienna Vienna Austria

Department of Urological Surgery Duke University Medical Center Durham NC USA

Department of Urology Amsterdam University Medical Centers University of Amsterdam Amsterdam The Netherlands

Department of Urology Atrium Health Wake Forest Baptist Winston Salem NC USA

Department of Urology Clinica Universidad de Navarra Madrid Spain

Department of Urology David Geffen School of Medicine at UCLA Los Angeles CA USA

Department of Urology Grenoble Alpes University Hospital Université Grenoble Alpes Grenoble France

Department of Urology Hospital Louis Pasteur Chartres France

Department of Urology Institut Mutualiste Montsouris Paris France

Department of Urology Instituto Valenciano de Oncologia Valencia Spain

Department of Urology Lenox Hill Hospital New York NY USA

Department of Urology St Vincent's Prostate Cancer Centre Sydney NSW Australia

Department of Urology University of Washington School of Medicine Seattle WA USA

Division of Surgery and Interventional Science University College London UK

Division of Urology Department of Surgery Faculty of Medicine SH Ho Urology Centre The Chinese University of Hong Kong Hong Kong SAR China

Division of Urology Department of Surgery McGill University Montreal QC Canada

Garvan Institute of Medical Research Sydney NSW Australia

International School of Medicine Istanbul Medipol University Istanbul Turkey

Interventional Oncology Division of Surgery and Interventional Science University College London London UK

Martini Klinik Prostate Cancer Center University Hospital Hamburg Eppendorf Hamburg Germany

Radiation Oncology Department Institut Gustave Roussy Villejuif France

St Vincent's Clinical School UNSW Sydney Sydney NSW Australia

Université Paris Cité Paris France

Urological Research Network Miami FL USA

Zobrazit více v PubMed

Sung H, Ferlay J, Siegel RL et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2021; 71: 209–249

Hoffman KE, Penson DF, Zhao Z et al. Patient‐reported outcomes through 5 years for active surveillance, surgery, brachytherapy, or external beam radiation with or without androgen deprivation therapy for localized prostate cancer. JAMA 2020; 323: 149–163

Klotz L. Active surveillance with selective delayed intervention using PSA doubling time for good risk prostate cancer. Eur Urol 2005; 47: 16–21

Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Fütterer JJ, Rovers MM. An updated systematic review on focal therapy in localized prostate cancer: what has changed over the past 5 years? Eur Urol 2022; 81: 5–33

Erickson A, Hayes A, Rajakumar T et al. A systematic review of prostate cancer heterogeneity: understanding the clonal ancestry of multifocal disease. Eur Urol Oncol 2021; 4: 358–369

Rodríguez Sánchez L, Macek P, Barbé Y, Cathelineau X, Sanchez‐Salas R. Re: MRI‐targeted, systematic, and combined biopsy for prostate cancer diagnosis. Eur Urol 2020; 78: 469–470

Gunashekar DD, Bielak L, Hägele L et al. Explainable AI for CNN‐based prostate tumor segmentation in multi‐parametric MRI correlated to whole mount histopathology. Radiat Oncol 2022; 17: 65

Al‐Bayati M, Grueneisen J, Lütje S et al. Integrated 68Gallium labelled prostate‐specific membrane Antigen‐11 positron emission tomography/magnetic resonance imaging enhances discriminatory power of multi‐parametric prostate magnetic resonance imaging. Urol Int 2018; 100: 164–171

Pidsley R, Lam D, Qu W et al. Comprehensive methylome sequencing reveals prognostic epigenetic biomarkers for prostate cancer mortality. Clin Transl Med 2022; 12: e1030

Ehdaie B, Tempany CM, Holland F et al. MRI‐guided focused ultrasound focal therapy for patients with intermediate‐risk prostate cancer: a phase 2b, multicentre study. Lancet Oncol 2022; 23: 910–918

Ganzer R, Arthanareeswaran VKA, Ahmed HU et al. Which technology to select for primary focal treatment of prostate cancer?—European Section of Urotechnology (ESUT) position statement. Prostate Cancer Prostatic Dis 2018; 21: 175–186

Rodríguez‐Sánchez L, Emberton M, de Reijke T et al. Revisiting Delphi to create a basis for the future of focal therapy for prostate cancer. World J Mens Health 2023; 42: 41

Nasa P, Jain R, Juneja D. Delphi methodology in healthcare research: how to decide its appropriateness. World J Methodol 2021; 11: 116–129

Gómez Rivas J, Somani B, Rodriguez Socarrás M et al. Essentials for standardising the undergraduate urology curriculum in Europe: outcomes of a Delphi consensus from the European School of Urology. Eur Urol Open Sci 2021; 33: 72–80

Lam TBL, MacLennan S, Willemse P‐PM et al. EAU‐EANM‐ESTRO‐ESUR‐SIOG prostate cancer guideline panel consensus statements for deferred treatment with curative intent for localised prostate cancer from an international collaborative study (DETECTIVE study). Eur Urol 2019; 76: 790–813

Teoh JY‐C, MacLennan S, Chan VW‐S et al. An international collaborative consensus statement on En bloc resection of bladder tumour incorporating two systematic reviews, a two‐round Delphi survey, and a consensus meeting. Eur Urol 2020; 78: 546–569

COMET Initiative. DelphiManager. Available at: https://www.comet‐initiative.org/delphimanager/. Accessed November 2023

Onik G, Barzell W. Transperineal 3D mapping biopsy of the prostate: an essential tool in selecting patients for focal prostate cancer therapy. Urol Oncol 2008; 26: 506–510

Muller BG, van den Bos W, Brausi M et al. Follow‐up modalities in focal therapy for prostate cancer: results from a Delphi consensus project. World J Urol 2015; 33: 1503–1509

Muller BG, van den Bos W, Brausi M et al. Role of multiparametric magnetic resonance imaging (MRI) in focal therapy for prostate cancer: a Delphi consensus project. BJU Int 2014; 114: 698–707

van Luijtelaar A, Greenwood BM, Ahmed HU et al. Focal laser ablation as clinical treatment of prostate cancer: report from a Delphi consensus project. World J Urol 2019; 37: 2147–2153

Tan WP, Rastinehad AR, Klotz L et al. Utilization of focal therapy for patients discontinuing active surveillance of prostate cancer: recommendations of an international Delphi consensus. Urol Oncol 2021; 39: 781.e17–24

Marra G, Laguna MP, Walz J et al. Molecular biomarkers in the context of focal therapy for prostate cancer: recommendations of a Delphi consensus from the focal therapy society. Minerva Urol Nephrol 2021; 74: 581–589

Tay KJ, Scheltema MJ, Ahmed HU et al. Patient selection for prostate focal therapy in the era of active surveillance: an international Delphi consensus project. Prostate Cancer Prostatic Dis 2017; 20: 294–299

Abreu AL, Kaneko M, Cacciamani GE, Lebastchi AH. Focal therapy for prostate cancer: getting ready for prime time. Eur Urol 2022; 81: 34–36

Stabile A, Orczyk C, Hosking‐Jervis F et al. Medium‐term oncological outcomes in a large cohort of men treated with either focal or hemi‐ablation using high‐intensity focused ultrasonography for primary localized prostate cancer. BJU Int 2019; 124: 431–440

Khan A, Khan AU, Siref L, Feloney M. Focal cryoablation of the prostate: primary treatment in 163 patients with localized prostate cancer. Cureus 2023; 15: e37172

Czaja RC, Tarima S, Wu R, Palagnmonthip W, Iczkowski KA. Comparative influence of cribriform growth and percent Gleason 4 in prostatic biopsies with Gleason 3 + 4 cancer. Ann Diagn Pathol 2021; 52: 151725

Calimano‐Ramirez LF, Virarkar MK, Hernandez M et al. MRI‐based nomograms and radiomics in presurgical prediction of extraprostatic extension in prostate cancer: a systematic review. Abdom Radiol 2023; 48: 2379–2400

Aslim EJ, Law YXT, Fook‐Chong SMC et al. Defining prostate cancer size and treatment margin for focal therapy: does intralesional heterogeneity impact the performance of multiparametric MRI? BJU Int 2021; 128: 178–186

Brisbane WG, Priester AM, Ballon J et al. Targeted prostate biopsy: umbra, penumbra, and value of perilesional sampling. Eur Urol 2022; 82: 303–310

Fernández‐Pascual E, Manfredi C, Martín C et al. mpMRI‐US fusion‐guided targeted cryotherapy in patients with primary localized prostate cancer: a prospective analysis of oncological and functional outcomes. Cancers (Basel) 2022; 14: 2988

Jeong D, Aggarwal S, Robinson J, Kumar N, Spearot A, Park DS. Exhaustive or exhausting? Evidence on respondent fatigue in long surveys. J Dev Econ 2023; 161: 102992