Focal therapy in prostate cancer: International multidisciplinary consensus on trial design Journal Article


Authors: Van Den Bos, W.; Muller, B. G.; Ahmed, H.; Bangma, C. H.; Barret, E.; Crouzet, S.; Eggener, S. E.; Gill, I. S.; Joniau, S.; Kovacs, G.; Pahernik, S.; De La Rosette, J. J.; Rouvière, O.; Salomon, G.; Ward, J. F.; Scardino, P. T.
Article Title: Focal therapy in prostate cancer: International multidisciplinary consensus on trial design
Abstract: Background Focal therapy has been introduced for the treatment of localised prostate cancer (PCa). To provide the necessary data for consistent assessment, all focal therapy trials should be performed according to uniform, systematic pre- and post-treatment evaluation with well-defined end points and strict inclusion and exclusion criteria. Objective To obtain consensus on trial design for focal therapy in PCa. Design, setting, and participants A four-staged consensus project based on a modified Delphi process was conducted in which 48 experts in focal therapy of PCa participated. According to this formal consensus-building method, participants were asked to fill out an iterative sequence of questionnaires to collect data on trial design. Subsequently, a consensus meeting was held in which 13 panellists discussed acquired data, clarified the results, and defined the conclusions. Outcome measurements and statistical analysis A multidisciplinary board from oncologic centres worldwide reached consensus on patient selection, pretreatment assessment, evaluation of outcome, and follow-up. Results and limitations Inclusion criteria for candidates in focal therapy trials are patients with prostate-specific antigen <15 ng/ml, clinical stage T1c-T2a, Gleason score 3 + 3 or 3 + 4, life expectancy of >10 yr, and any prostate volume. The optimal biopsy strategy includes transrectal ultrasound-guided biopsies to be taken between 6 mo and 12 mo after treatment. The primary objective should be focal ablation of clinically significant disease with negative biopsies at 12 mo after treatment as the primary end point. Conclusions This consensus report provides a standard for designing a feasible focal therapy trial. Patient summary A variety of ablative technologies have been introduced and applied in a focal manner for the treatment of prostate cancer (PCa). In this consensus report, an international panel of experts in the field of PCa determined pre- and post-treatment work-up for focal therapy research. © 2014 European Association of Urology.
Keywords: treatment failure; histopathology; patient selection; cancer staging; nuclear magnetic resonance imaging; outcome assessment; follow up; prostate specific antigen; consensus; quality of life; practice guideline; cancer therapy; prostate cancer; gleason score; standard; questionnaire; systematic review; contrast enhancement; high intensity focused ultrasound; prostate biopsy; brachytherapy; nuclear magnetic resonance spectroscopy; electroporation; delphi study; anxiety; radiofrequency ablation; antibiotic prophylaxis; photodynamic therapy; life expectancy; transrectal ultrasonography; diffusion weighted imaging; nomogram; pathologist; functional status; predictive value; cryotherapy; low level laser therapy; urethral catheter; international index of erectile function; study design; focal therapy; prostate volume; irreversible electroporation; elastography; uroflowmetry; trial design; international prostate symptom score; image guided biopsy; human; priority journal; article; real time elastography; shear wave elastography; transrectal ultrasound guided biopsy
Journal Title: European Urology
Volume: 65
Issue: 6
ISSN: 0302-2838
Publisher: Elsevier Science, Inc.  
Date Published: 2014-06-01
Start Page: 1078
End Page: 1083
Language: English
DOI: 10.1016/j.eururo.2014.01.001
PROVIDER: scopus
PUBMED: 24444476
DOI/URL:
Notes: Eur. Urol. -- Cited By (since 1996):3 -- Export Date: 2 June 2014 -- CODEN: EUURA -- Source: Scopus
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  1. Peter T Scardino
    671 Scardino