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)
Lam, Thomas B L; MacLennan, Steven; Willemse, Peter-Paul M; Mason, Malcolm D; Plass, Karin; Shepherd, Robert; Baanders, Ruud; Bangma, Chris H; Bjartell, Anders; Bossi, Alberto; Briers, Erik; Briganti, Alberto; Buddingh, Karel T; Catto, James W F; Colecchia, Maurizio; Cox, Brett W; Cumberbatch, Marcus G; Davies, Jeff; Davis, Niall F; De Santis, Maria; Dell'Oglio, Paolo; Deschamps, André; Donaldson, James F; Egawa, Shin; Fankhauser, Christian D; Fanti, Stefano; Fossati, Nicola; Gandaglia, Giorgio; Gillessen, Silke; Grivas, Nikolaos; Gross, Tobias; Grummet, Jeremy P; Henry, Ann M; Ingels, Alexandre; Irani, Jacques; Lardas, Michael; Liew, Matthew; Lin, Daniel W; Moris, Lisa; Omar, Muhammad Imran; Pang, Karl H; Paterson, Catherine C; Renard-Penna, Raphaële; Ribal, Maria J; Roobol, Monique J; Rouprêt, Morgan; Rouvière, Olivier; Sancho Pardo, Gemma; Richenberg, Jonathan; Schoots, Ivo G; Sedelaar, J P Michiel; Stricker, Phillip; Tilki, Derya; Vahr Lauridsen, Susanne; van den Bergh, Roderick C N; Van den Broeck, Thomas; van der Kwast, Theodorus H; van der Poel, Henk G; van Leenders, Geert J L H; Varma, Murali; Violette, Philippe D; Wallis, Christopher J D; Wiegel, Thomas; Wilkinson, Karen; Zattoni, Fabio; N'Dow, James M O; Van Poppel, Hendrik; Cornford, Philip; Mottet, Nicolas
(2019) European Urology, volume 76, issue 6, pp. 790 - 813
(Article)
Abstract
BACKGROUND: There is uncertainty in deferred active treatment (DAT) programmes, regarding patient selection, follow-up and monitoring, reclassification, and which outcome measures should be prioritised. OBJECTIVE: To develop consensus statements for all domains of DAT. DESIGN, SETTING, AND PARTICIPANTS: A protocol-driven, three phase study was undertaken by the European Association of
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Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Association of Urology Section of Urological Research (ESUR)-International Society of Geriatric Oncology (SIOG) Prostate Cancer Guideline Panel in conjunction with partner organisations, including the following: (1) a systematic review to describe heterogeneity across all domains; (2) a two-round Delphi survey involving a large, international panel of stakeholders, including healthcare practitioners (HCPs) and patients; and (3) a consensus group meeting attended by stakeholder group representatives. Robust methods regarding what constituted the consensus were strictly followed. RESULTS AND LIMITATIONS: A total of 109 HCPs and 16 patients completed both survey rounds. Of 129 statements in the survey, consensus was achieved in 66 (51%); the rest of the statements were discussed and voted on in the consensus meeting by 32 HCPs and three patients, where consensus was achieved in additional 27 statements (43%). Overall, 93 statements (72%) achieved consensus in the project. Some uncertainties remained regarding clinically important thresholds for disease extent on biopsy in low-risk disease, and the role of multiparametric magnetic resonance imaging in determining disease stage and aggressiveness as a criterion for inclusion and exclusion. CONCLUSIONS: Consensus statements and the findings are expected to guide and inform routine clinical practice and research, until higher levels of evidence emerge through prospective comparative studies and clinical trials. PATIENT SUMMARY: We undertook a project aimed at standardising the elements of practice in active surveillance programmes for early localised prostate cancer because currently there is great variation and uncertainty regarding how best to conduct them. The project involved large numbers of healthcare practitioners and patients using a survey and face-to-face meeting, in order to achieve agreement (ie, consensus) regarding best practice, which will provide guidance to clinicians and researchers.
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Keywords: Active surveillance and monitoring, Clinical practice guidelines, Consensus group meeting, Consensus statements, Deferred treatment with curative intent, Delphi survey, Eligibility, Follow-up, Localised prostate cancer, Outcome measures, Reclassification
ISSN: 0302-2838
Publisher: Elsevier
Note: Funding Information: Financial disclosures: Thomas B.L. Lam certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Dr. T.B.L. Lam is a company consultant for and has received company speaker honoraria from Pfizer, GSK, Astellas, and IPSEN. Professor Dr. M.D. Mason is a company consultant for Ellipses Pharma and Oncotherics. Professor Dr. A. Bjartell is a company consultant for Astellas and Janssen; receives speaker honorarium from Astellas, Janssen, IPSEN, Bayer, and Ferring; participates in trials run by Astellas, Janssen, Pfizer, Ferring, and Myovant; received travel grants from Astellas, Bayer, Ferring, IPSEN, and Janssen; received research support from Astellas, Ferring, and Bayer, and financial compensation as Senior Consulting Editor of European Urology ; and holds stock in LIDDS Pharma AB, Glactone Pharma AB, and WntResearch AB. Professor Dr. A. Bossi is the head of the GU Unit at the Radiation Oncology Department of the Gustave Roussy Institute, Villejuif, France; is a company consultant for Sanofi and Astellas; receives company speaker honorarium from IPSEN, Janssen, and Astellas; and is a co-principal investigator for the PEACE 1 trial run by UNICANCER. Dr. E. Briers has received grant and research support from IPSEN, the European Association of Urology, and Bayer; is an ex officio board member for Europa UOMO; is an ethics committee and advisory group member for REQUITE; is a patient advisory board member for PAGMI; and is a member of SCA and EMA PCWP. Professor Dr. A. Briganti is a company consultant for Astellas, Janssen, Opko Health, MDx Health, and Bayer; received company speaker honorarium from Astellas and Ferring; and received research support from Sandoz. Professor Dr. J. W.F. Catto received company consultant honoraria from Steba Biotech, AstraZeneca, Merck Sharp & Dohme, BMS, and Nucleix Ltd. Dr. B.W. Cox declares an equity interest in C4 Imaging, LLC. Professor Dr. M. De Santis is a company consultant for Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Dendreon, Eisai Inc., ESSA, Ferring, GSK, Incyte, IPSEN, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, SeaGen, Shionogi, Synthon, Takeda, Teva, OncoGenex, and Sandoz; receives speaker honoraria from Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Ferring, GSK, IPSEN, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, Synthon, and Takeda; participates in trials run by the Technical University Munich, Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Dendreon, Eisai Inc, Ferring, GSK, IPSEN, Incyte, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, SOTIO, and Cancer Research UK; participates in various trials as a member of the EORTC GU group; and has received research grants from Pierre Fabre Oncologie, and travel grants from Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Dendreaon, Ferring, GSK, IPSEN, Incyte, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, SeaGen, Shionogi, Synthon, Takeda, and Teva/OncoGenex. Dr. J.F. Donaldson received travel grants from the Urology Foundation and the Royal College of Surgeons, Edinburgh, and participated in clinical trials by the National Institute for Health Research Technology Assessment Programme, Ethicon, and the Princess Alexandra Hospital, Brisbane, Australia (ProPSMA trial, Cx Bladder, CKD-TUNED). Professor Dr. S. Egawa received research support from Astellas Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Fuji Film Toyama Chemical Co Ltd. Professor Dr. S. Fanti is a company consultant for Bayer and ANMI; has received speaker honorarium from Bayer, Genzyme, ANMI, and GE Healthcare; and participates in trials by Amgen, Bayer, BMS, Genzyme, Janssen, Merck, and Novartis. Professor Gillessen has served on advisory boards for Orion, Innocrin, Clovis, Bayer, AAA International, Roche, Menarini, Sanofi, ProteoMedix; received company speaker honorarium from Janssen; and has served on the IDMC for Janssen. Professor Dr. J.P. Grummet received speaker honorarium from Mundipharma, a travel grant from Astellas, and a research grant from Cancer Australia; and is the owner of MRI PRO Pty Ltd., and online training platform. Professor Dr. A.M. Henry participates in trials by Cancer Research UK and the National Institute of Health Research; her department receives research grants from Cancer research UK, The Medical Research Council and the National Institute of Health. Professor Dr. M.J. Ribal receives company speaker honorarium from IPSEN, Janssen, and Astellas; and holds a patent for ‘Method for non-invasive diagnosis of bladder cancer’, European Patent Office (Grant number: 13382030.8-1403. Entity holder: Fina Biotech, S.L.U. June 2007). Professor Dr. M. Roobol receives research grants from Beckman. Professor Dr. M. Rouprêt is a company consultant for Lilly, GSK, Ipsen, Astellas, Takeda, Sanofi Pasteur, and Medac; received research support from GSK, Pfizer, and Roche; and received speaker honorarium from Roche and Zambon. Professor Dr. D. Tilki received speaker honorarium from Astellas and a travel grant from Janssen. Professor Dr. H.G. van der Poel is a company consultant for Intuitive Surgical; has participated in trials for Astellas and Steba Biotech; and has received grant and research support from Astellas. Professor Dr. G.J.L.A. van Leenders has served on the advisory board for Roche, and received company speaker honorarium from Astellas and research grants from Roche and AstraZeneca. Professor Dr. P.D. Violette received company speaker honoraria from Janssen and Sanofi. Professor Dr. T. Wiegel is an advisory board member for IPSEN; receives company speaker honoraria from IPSEN and Hexal; is a member of the Janssen Steering Committee; and has participated in the ATLAS/AUO trial. Dr. F. Zattoni holds a patent for “Sign In Indirect visualization-assisted apparatus and method for positioning medical instruments” European Patent Office (Grant number EP3261551A1. Entity holder: FABER IND SpA, Faber Industrie SpA). Professor Dr. P. Cornford is a company consultant for Astellas, IPSEN, and Ferring; receives company speaker honoraria from Astellas, Janssen, IPSEN, and Pfizer; participates in trials run by Ferring; and receives fellowships and travel grants from Astellas and Janssen. Professor Dr. N. Mottet is a company consultant for Janssen, GE, BMS, Sanofi, and Astellas; has received speaker honoraria from Astellas, Pierre Fabre, Steba, Janssen, and Ferring; and has received fellowships and travel grants from Astellas, IPSEN, Sanofi, Janssen, and Roche. Dr. S. MacLennan, Dr. P-P.M. Willemse, Ms. K. Plass, R. Shepherd, Mr. R. Baanders, Professor Dr. C.H. Bangma, Dr. K.T. Buddingh, Professor Dr. M. Colecchia, Mr. M.G. Cumberbatch, Mr. J. Davies, Mr. N.F. Davis, Dr. P. Dell'Oglio, Mr. A. Deschamps, Dr. C. Fankhauser, Dr. N. Fossati, Dr. G. Gandaglia, Dr. N. Grivas, Dr. T. Gross, Dr. A. Ingels, Professor Dr. J. Irani, Dr. M. Lardas, Professor Dr. D.W. Lin, Dr. M. Liew, Dr. L. Moris, Dr. M.I. Omar, Mr. K.H. Pang, Dr. C. Paterson, Professor Dr. R. Renard-Penna, Professor Dr. O. Rouvière, Professor Dr. G. Sancho Pardo, Professor Dr. J. Richenberg, Dr I.G. Schoots, Dr. J.P.M. Sedelaar, Mrs. S. Vahr, Dr. R.C.N. van den Bergh, Dr. T. Van den Broeck, Professor Dr. T.H. van der Kwast, Dr. M. Varma, Dr. C.J.D. Wallis, Mrs. K. Wilkinson, Professor Dr. J.M.O. N'Dow, Professor Dr. H. van Poppel have nothing to disclose. Publisher Copyright: © 2019
(Peer reviewed)