TY - JOUR
T1 - Study Protocol for the DETECTIVE Study
T2 - An International Collaborative Study To Develop Consensus Statements for Deferred Treatment with Curative Intent for Localised Prostate Cancer
AU - Lam, Thomas B L
AU - MacLennan, Steven
AU - Plass, Karin
AU - Willemse, Peter-Paul M
AU - Mason, Malcolm D
AU - Cornford, Philip
AU - Donaldson, James
AU - Davis, Niall F
AU - Dell'Oglio, Paolo
AU - Fankhauser, Christian
AU - Grivas, Nikos
AU - Ingels, Alexandre
AU - Lardas, Michael
AU - Liew, Matthew
AU - Pang, Karl H
AU - Paterson, Catherine
AU - Omar, Muhammad I
AU - Zattoni, Fabio
AU - Buddingh, Karel T
AU - Van den Broeck, Thomas
AU - Cumberbatch, Marcus G
AU - Fossati, Nicola
AU - Gross, Tobias
AU - Moris, Lisa
AU - Schoots, Ivo G
AU - van den Bergh, Roderick C N
AU - Briers, Erik
AU - Fanti, Stefano
AU - De Santis, Maria
AU - Gillessen, Silke
AU - Grummet, Jeremy P
AU - Henry, Ann M
AU - van der Poel, Henk G
AU - van der Kwast, Theodorus H
AU - Rouvière, Olivier
AU - Tilki, Derya
AU - Wiegel, Thomas
AU - N'Dow, James
AU - Van Poppel, Hendrik
AU - Mottet, Nicolas
N1 - Funding Information:
Conflicts of interest: Thomas B.L. Lam is a company consultant for and has received company speaker honoraria from Pfizer, GSK, Astellas, and Ipsen. Malcolm D. Mason is a company consultant for Ellipses Pharma and Oncotherics. Philip 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. Erik 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. Stefano Fanti is a company consultant for Bayer and ANMI; has received speaker honoraria from Bayer, Genzyme, ANMI, and GE Healthcare; and participates in trials run by Amgen, Bayer, BMS, Genzyme, Janssen, Merck, and Novartis. Maria 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, Piere 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, and SOTIO; and as a member of the EORTC GU group participates in various trials. She 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. Silke Gillessen is a company consultant for AAA International, Astellas Pharma, Bayer, Bristol-Myers Squibb, Clovis, CureVac, Ferring, Innocrin Pharmaceuticals, Janssen Cilag, MaxIVAX SA, Orion, Roche, Sanofi Aventis Group, Nectar, and ProteoMediX; has received speaker honoraria from Janssen and Novartis; and participates in multiple trials run by different companies. Ann M. Henry is a company consultant for Nucletron-Elektra; participates in trials run by Cancer Research UK and the National Institute of Health Research (UK); ahs received travel grants from the Medical Research Council, the National Institute of Health Research (UK), and Cancer Research UK; and has received research grants from Cancer Research UK and the Sir John Fisher Foundation. Henk 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. Thomas 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. Olivier Rouvière has received company speaker honoraria from EDAP-TMS; participates in trials run by ESAO-TMS and Vermon; and has received research and travel grants from Philips. Derya Tilki is a company consultant for Steba Biotech and MDx Health; has received speaker honoraria from Mundipharma, Astellas, and Ribosepharm; participates in trials run by MDx Health; has received travel and research grants from Janssen; and is a member of the PIONEER consortium. Nicolas 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. The remaining authors have nothing to disclose.
PY - 2019/4
Y1 - 2019/4
N2 - Deferred active treatment (DAT) strategies for men with localised prostate cancer have emerged as a viable alternative to radical intervention as we aim to avoid the consequences of overtreatment. Nevertheless, such strategies remain controversial, with significant uncertainty and heterogeneity in all domains, including criteria for patient selection, the nature and timing of interventions during follow-up, criteria and thresholds for reclassification, and which outcome measures should be prioritised [1], [2], [3]. These are important barriers to the conduct and uptake of DAT by clinicians and patients as they prohibit comparison of the clinical effectiveness of different protocols. In order to address these issues in a comprehensive, robust, and systematic manner, the European Association of Urology (EAU) Prostate Cancer Guidelines Panel, in partnership with other leading guideline authorities and organisations (listed in Appendix A), has commissioned a project to develop consensus statements for all domains relating to DAT to standardise clinical practice and research.
AB - Deferred active treatment (DAT) strategies for men with localised prostate cancer have emerged as a viable alternative to radical intervention as we aim to avoid the consequences of overtreatment. Nevertheless, such strategies remain controversial, with significant uncertainty and heterogeneity in all domains, including criteria for patient selection, the nature and timing of interventions during follow-up, criteria and thresholds for reclassification, and which outcome measures should be prioritised [1], [2], [3]. These are important barriers to the conduct and uptake of DAT by clinicians and patients as they prohibit comparison of the clinical effectiveness of different protocols. In order to address these issues in a comprehensive, robust, and systematic manner, the European Association of Urology (EAU) Prostate Cancer Guidelines Panel, in partnership with other leading guideline authorities and organisations (listed in Appendix A), has commissioned a project to develop consensus statements for all domains relating to DAT to standardise clinical practice and research.
UR - http://www.scopus.com/inward/record.url?scp=85062005138&partnerID=8YFLogxK
U2 - 10.1016/j.eururo.2018.11.009
DO - 10.1016/j.eururo.2018.11.009
M3 - Letter
C2 - 30473433
SN - 0302-2838
VL - 75
SP - 699
EP - 702
JO - European Urology
JF - European Urology
IS - 4
ER -
