Focal therapy in prostate cancer: international multidisciplinary consensus on trial design.
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.


METHODS
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.


METHODS
A multidisciplinary board from oncologic centres worldwide reached consensus on patient selection, pretreatment assessment, evaluation of outcome, and follow-up.


CONCLUSIONS
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.


RESULTS
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.
Department of Urology, AMC University Hospital, Amsterdam, The Netherlands. Electronic address: w.vandenbos@amc.uva.nl.
Willemien
W
van den Bos
Department of Urology, AMC University Hospital, Amsterdam, The Netherlands.
Berrend G
BG
Muller
Division of Surgery and Interventional Science, London, UK.
Hashim
H
Ahmed
Department of Urology, Erasmus MC Rotterdam, The Netherlands.
Chris H
CH
Bangma
Department of Urology, Institut Montsouris, Paris, France.
Eric
E
Barret
Hospices Civils de Lyon, Department of Urology, Edouard Herriot Hospital, Lyon, France.
Sebastien
S
Crouzet
Department of Urology, University of Chicago, Chicago, IL, USA.
Scott E
SE
Eggener
Institute of Urology, Hillard and Roclyn Herzog Center for Prostate Cancer Focal Therapy, Keck School of Medicine, Los Angeles, CA, USA.
Inderbir S
IS
Gill
Department of Urology, University Hospitals Leuven, Belgium.
Steven
S
Joniau
Interdisciplinary Brachytherapy Unit, University of Lübeck, Lübeck, Germany.
Gyoergy
G
Kovacs
Department of Urology, University Clinic Heidelberg, Heidelberg, Germany.
Sascha
S
Pahernik
Department of Urology, AMC University Hospital, Amsterdam, The Netherlands.
Jean J
JJ
de la Rosette
Hospices Civils de Lyon, Department of Radiology, Hôpital E. Herriot, Université de Lyon, Lyon, France.
Olivier
O
Rouvière
Department of Urology, University Medical Centre Hamburg, Hamburg, Germany.
Georg
G
Salomon
Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
John F
JF
Ward
Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Peter T
PT
Scardino
D017115:Catheter Ablation; D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D003452:Cryosurgery; D003697:Delphi Technique; D018274:Electroporation; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration; D057086:High-Intensity Focused Ultrasound Ablation; D006801:Humans; D053685:Laser Therapy; D008279:Magnetic Resonance Imaging; D008297:Male; D018579:Patient Selection; D010778:Photochemotherapy; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000628:therapy*; D017211:Treatment Failure
D017430:Prostate-Specific Antigen
Focal therapy; Prostate cancer; Trial design