Document is current

Article History

Accepted: 20 August 2021

First Online: 3 September 2021

Declarations

:

: This study was funded by AstraZeneca and is part of an alliance between AstraZeneca and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

: Rachel Evans—Advisory/consultancy: AstraZeneca. Employment: Visible Analytics. Neil Hawkins—Advisory/consultancy: AstraZeneca. Employment: Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK. Employee of Visible Analytics. Pascale Dequen-O’Byrne—Advisory/consultancy: AstraZeneca. Employment: Visible Analytics. Charles McCrea—Employment and stock ownership: AstraZeneca. Dominic Muston—Employment: Merck. Christopher Gresty—Employment and stock ownership: AstraZeneca. Sameer Ghate—Employment: Merck. Lin Fan—Employment: Merck. Robert Hettle—Employment and stock ownership: AstraZeneca. Keith Abrams—Advisory/consultancy: AstraZeneca. Affiliated (as an employee until 31 December 2020) to: Department of Health Sciences, University of Leicester, Leicester, UK. Partially supported as a UK National Institute for Health Research (NIHR) Senior Investigator Emeritus (NF-SI-0512-10159). The views expressed are those of the author and not necessarily those of NHS, NHS or Department of Health & Social Care. Employee of Visible Analytics. Johann de Bono—Advisory boards and received fees from many companies, including: Astra Zeneca, Astellas, Bayer, Bioxcel Therapeutics, Boehringer Ingelheim, Cellcentric, Daiichi, Eisai, Genentech/Roche, Genmab, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Menarini/Silicon Biosystems, Orion, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Vertex Pharmaceuticals. Employment: The ICR, which have received funding or other support for his research work from AZ, Astellas, Bayer, Cellcentric, Daiichi, Genentech, Genmab, GSK, Janssen, Merck Serono, MSD, Menarini/Silicon Biosystems, Orion, Sanofi Aventis, Sierra Oncology, Taiho, Pfizer, Vertex, and which has a commercial interest in abiraterone, PARP inhibition in DNA repair defective cancers and PI3K/AKT pathway inhibitors (no personal income). Patent: Named as an inventor, with no financial interest, for patent 8,822,438. He has been the CI/PI of many industry sponsored clinical trials. JDB is a National Institute for Health Research (NIHR) Senior Investigator. The views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health. Maha Hussain—Grant support (paid to Northwestern University): AstraZeneca, Prostate Cancer Clinical Trials Consortium. Advisory board fees, travel support and grant support (paid to Northwestern University): Bayer. Advisory board fees, travel support and grant support (paid to University of Michigan): Pfizer. Advisory board fees, lecture fees, travel support and grant support (paid to Northwestern University): Genentech. Travel support and honoraria (lecture): Astellas. Honoraria (lecture): Physicians’ Education Resource^®, Sanofi/Genzyme, Phillips Gilmore Oncology, MLI Peer Review. Honoraria (educational material): Projects in Knowledge. Honoraria (educational review): Research to Practice. Neeraj Agarwal—Advisory board fees: Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Clovis Oncology, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation Medicine, Genentech, Janssen Biotech, Merck, Nektar Therapeutics, Novartis, Pfizer, Pharmacyclics (an AbbVie company), Seattle Genetics.

: This trial was performed in accordance with the principles of the Declaration of Helsinki, Good Clinical Practice guidelines, and the AstraZeneca and Merck policies on bioethics.

: All patients provided written informed consent to participate.

: All authors have reviewed the final submitted document and agreed to publication.

: Data underlying the findings described in this article may be obtained in accordance with AstraZeneca’s data-sharing policy described at.

: Not applicable.

: Conception and design: Rachel Evans; Neil Hawkins; Pascale Dequen-O’Byrne; Charles McCrea; Robert Hettle; Keith R. Abrams. Acquisition of data: Christopher Gresty. Analysis and interpretation of data: Rachel Evans; Neil Hawkins; Pascale Dequen-O’Byrne; Charles McCrea; Dominic Muston; Christopher Gresty; Sameer R. Ghate; Lin Fan; Robert Hettle; Keith R. Abrams; Johann de Bono; Maha Hussain; Neeraj Agarwal. Drafting of the manuscript: Rachel Evans; Neil Hawkins; Pascale Dequen-O’Byrne; Charles McCrea; Dominic Muston; Christopher Gresty; Sameer R. Ghate; Lin Fan; Robert Hettle; Keith R. Abrams; Johann de Bono; Maha Hussain; Neeraj Agarwal. Critical revision of the manuscript for important intellectual content: Rachel Evans; Neil Hawkins; Pascale Dequen-O’Byrne; Charles McCrea; Dominic Muston; Christopher Gresty; Sameer R. Ghate; Lin Fan; Robert Hettle; Keith R. Abrams; Johann de Bono; Maha Hussain; Neeraj Agarwal. Statistical analysis: Rachel Evans; Neil Hawkins; Pascale Dequen-O’Byrne; Charles McCrea; Christopher Gresty; Robert Hettle; Keith R. Abrams. Obtaining funding: Charles McCrea; Dominic Muston; Sameer R. Ghate; Lin Fan; Robert Hettle. Administrative, technical, or material support: Rachel Evans; Neil Hawkins; Pascale Dequen-O’Byrne; Charles McCrea; Dominic Muston; Christopher Gresty; Sameer R. Ghate; Lin Fan; Robert Hettle; Keith R. Abrams; Johann de Bono; Maha Hussain; Neeraj Agarwal. Supervision: Charles McCrea.