ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI

Teresa Marsden; Derek J Lomas; Neil Mccartan; Joanna Hadley; Steve Tuck; Louise Brown; Anna Haire; Charlotte Louise Moss; Saran Green; Mieke Van Hemelrijck; Ton Coolen; Aida Santaolalla; Elizabeth Isaac; Giorgio Brembilla; Douglas Kopcke; Francesco Giganti; Harbir Sidhu; Shonit Punwani; Mark Emberton; Caroline M Moore

doi:10.1136/bmjopen-2020-048144

ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI

Teresa Marsden, Derek J Lomas, Neil Mccartan, Joanna Hadley, Steve Tuck, Louise Brown, Anna Haire, Charlotte Louise Moss, Saran Green, Mieke Van Hemelrijck, Ton Coolen, Aida Santaolalla, Elizabeth Isaac, Giorgio Brembilla, Douglas Kopcke, Francesco Giganti, Harbir Sidhu, Shonit Punwani, Mark Emberton, Caroline M Moore

Comprehensive Cancer Centre

Research output: Contribution to journal › Article › peer-review

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Abstract

Introduction The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI.

Methods and analysis The ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50–75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI scan and a prostate-specific antigen (PSA) blood test. The screening MRI scan consists of T2-weighted, diffusion-weighted and research-specific sequences, without the use of intravenous contrast agents. Men who screen positive on either MRI or PSA density will be recommended to have standard of care (National Health Service) tests for prostate cancer assessment, which includes multiparametric MRI. The study will assess the acceptability of an MRI-based prostate screening assessment and the prevalence of cancer detected in MRI-screened men. Summary statistics will be used to explore baseline characteristics in relation to acceptance rates and prevalence of cancer.

Ethics and dissemination ReIMAGINE Prostate Cancer Screening is a single-site screening study to assess the feasibility of MRI as a screening tool for prostate cancer. Ethical approval was granted by London–Stanmore Research Ethics Committee Heath Research Authority (reference 19/LO/1129). Study results will be published in peer-reviewed journals after completion of data analysis and used to inform the design of a multicentre screening study in the UK.

Trial registration number ClinicalTrials.gov Registry (NCT04063566).

Original language	English
Article number	e048144
Journal	BMJ Open
Volume	11
Issue number	9
Early online date	30 Sept 2021
DOIs	https://doi.org/10.1136/bmjopen-2020-048144
Publication status	Published - 30 Sept 2021

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10.1136/bmjopen-2020-048144Licence: CC BY

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Marsden, T., Lomas, D. J., Mccartan, N., Hadley, J., Tuck, S., Brown, L., Haire, A., Moss, C. L., Green, S., Van Hemelrijck, M., Coolen, T., Santaolalla, A., Isaac, E., Brembilla, G., Kopcke, D., Giganti, F., Sidhu, H., Punwani, S., Emberton, M., & Moore, C. M. (2021). ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI. BMJ Open, 11(9), Article e048144. https://doi.org/10.1136/bmjopen-2020-048144

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title = "ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI",

abstract = "Introduction The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI.Methods and analysis The ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50–75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI scan and a prostate-specific antigen (PSA) blood test. The screening MRI scan consists of T2-weighted, diffusion-weighted and research-specific sequences, without the use of intravenous contrast agents. Men who screen positive on either MRI or PSA density will be recommended to have standard of care (National Health Service) tests for prostate cancer assessment, which includes multiparametric MRI. The study will assess the acceptability of an MRI-based prostate screening assessment and the prevalence of cancer detected in MRI-screened men. Summary statistics will be used to explore baseline characteristics in relation to acceptance rates and prevalence of cancer.Ethics and dissemination ReIMAGINE Prostate Cancer Screening is a single-site screening study to assess the feasibility of MRI as a screening tool for prostate cancer. Ethical approval was granted by London–Stanmore Research Ethics Committee Heath Research Authority (reference 19/LO/1129). Study results will be published in peer-reviewed journals after completion of data analysis and used to inform the design of a multicentre screening study in the UK.Trial registration number ClinicalTrials.gov Registry (NCT04063566).",

author = "Teresa Marsden and Lomas, {Derek J} and Neil Mccartan and Joanna Hadley and Steve Tuck and Louise Brown and Anna Haire and Moss, {Charlotte Louise} and Saran Green and {Van Hemelrijck}, Mieke and Ton Coolen and Aida Santaolalla and Elizabeth Isaac and Giorgio Brembilla and Douglas Kopcke and Francesco Giganti and Harbir Sidhu and Shonit Punwani and Mark Emberton and Moore, {Caroline M}",

note = "Funding Information: Funding ReIMAGINE Screening is funded by The Medical Research Council, UK (MRC), grant number MR/R014043/1 and Cancer Research UK (CRUK). ME receives research support from the UK{\textquoteright}s National Institute of Health Research (NIHR) UCLH/ UCL Biomedical Research Centre. SP receives research support from the UK{\textquoteright}s NIHR UCLH/UCL Biomedical Research Centre. FG is funded by the UCL Graduate Research Scholarship and the Brahm PhD scholarship in memory of Chris Adams. TC receives funding from Cancer Research UK and is director of Saddle Point Science. Funding Information: Competing interests CMM receives funding from the Prostate Cancer UK, Movember, the Medical Research Council, Cancer Research UK and the NIHR. She receives fees for HIFU proctoring from SonaCare. She has received speaker fees from Astellas and Jannsen. She carries out research into photodynamic therapy supported by Spectracure. ME serves as a consultant/educator/trainer to Sonacare, Exact Imaging, Angiodynamics and Profound Medical. Funding Information: This study is supported by the Medical Research Council (grant number MR/R014043/1) and Cancer Research UK. The chief investigator and principal investigators have no financial interests in the products or companies involved in the study. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021.",

year = "2021",

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doi = "10.1136/bmjopen-2020-048144",

language = "English",

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Marsden, T, Lomas, DJ, Mccartan, N, Hadley, J, Tuck, S, Brown, L, Haire, A , Moss, CL, Green, S, Van Hemelrijck, M, Coolen, T, Santaolalla, A, Isaac, E, Brembilla, G, Kopcke, D, Giganti, F, Sidhu, H, Punwani, S, Emberton, M & Moore, CM 2021, 'ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI', BMJ Open, vol. 11, no. 9, e048144. https://doi.org/10.1136/bmjopen-2020-048144

TY - JOUR

T1 - ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI

AU - Marsden, Teresa

AU - Lomas, Derek J

AU - Mccartan, Neil

AU - Hadley, Joanna

AU - Tuck, Steve

AU - Brown, Louise

AU - Haire, Anna

AU - Moss, Charlotte Louise

AU - Green, Saran

AU - Van Hemelrijck, Mieke

AU - Coolen, Ton

AU - Santaolalla, Aida

AU - Isaac, Elizabeth

AU - Brembilla, Giorgio

AU - Kopcke, Douglas

AU - Giganti, Francesco

AU - Sidhu, Harbir

AU - Punwani, Shonit

AU - Emberton, Mark

AU - Moore, Caroline M

N1 - Funding Information: Funding ReIMAGINE Screening is funded by The Medical Research Council, UK (MRC), grant number MR/R014043/1 and Cancer Research UK (CRUK). ME receives research support from the UK’s National Institute of Health Research (NIHR) UCLH/ UCL Biomedical Research Centre. SP receives research support from the UK’s NIHR UCLH/UCL Biomedical Research Centre. FG is funded by the UCL Graduate Research Scholarship and the Brahm PhD scholarship in memory of Chris Adams. TC receives funding from Cancer Research UK and is director of Saddle Point Science. Funding Information: Competing interests CMM receives funding from the Prostate Cancer UK, Movember, the Medical Research Council, Cancer Research UK and the NIHR. She receives fees for HIFU proctoring from SonaCare. She has received speaker fees from Astellas and Jannsen. She carries out research into photodynamic therapy supported by Spectracure. ME serves as a consultant/educator/trainer to Sonacare, Exact Imaging, Angiodynamics and Profound Medical. Funding Information: This study is supported by the Medical Research Council (grant number MR/R014043/1) and Cancer Research UK. The chief investigator and principal investigators have no financial interests in the products or companies involved in the study. Publisher Copyright: © Author(s) (or their employer(s)) 2021.

PY - 2021/9/30

Y1 - 2021/9/30

N2 - Introduction The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI.Methods and analysis The ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50–75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI scan and a prostate-specific antigen (PSA) blood test. The screening MRI scan consists of T2-weighted, diffusion-weighted and research-specific sequences, without the use of intravenous contrast agents. Men who screen positive on either MRI or PSA density will be recommended to have standard of care (National Health Service) tests for prostate cancer assessment, which includes multiparametric MRI. The study will assess the acceptability of an MRI-based prostate screening assessment and the prevalence of cancer detected in MRI-screened men. Summary statistics will be used to explore baseline characteristics in relation to acceptance rates and prevalence of cancer.Ethics and dissemination ReIMAGINE Prostate Cancer Screening is a single-site screening study to assess the feasibility of MRI as a screening tool for prostate cancer. Ethical approval was granted by London–Stanmore Research Ethics Committee Heath Research Authority (reference 19/LO/1129). Study results will be published in peer-reviewed journals after completion of data analysis and used to inform the design of a multicentre screening study in the UK.Trial registration number ClinicalTrials.gov Registry (NCT04063566).

AB - Introduction The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI.Methods and analysis The ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50–75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI scan and a prostate-specific antigen (PSA) blood test. The screening MRI scan consists of T2-weighted, diffusion-weighted and research-specific sequences, without the use of intravenous contrast agents. Men who screen positive on either MRI or PSA density will be recommended to have standard of care (National Health Service) tests for prostate cancer assessment, which includes multiparametric MRI. The study will assess the acceptability of an MRI-based prostate screening assessment and the prevalence of cancer detected in MRI-screened men. Summary statistics will be used to explore baseline characteristics in relation to acceptance rates and prevalence of cancer.Ethics and dissemination ReIMAGINE Prostate Cancer Screening is a single-site screening study to assess the feasibility of MRI as a screening tool for prostate cancer. Ethical approval was granted by London–Stanmore Research Ethics Committee Heath Research Authority (reference 19/LO/1129). Study results will be published in peer-reviewed journals after completion of data analysis and used to inform the design of a multicentre screening study in the UK.Trial registration number ClinicalTrials.gov Registry (NCT04063566).

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U2 - 10.1136/bmjopen-2020-048144

DO - 10.1136/bmjopen-2020-048144

M3 - Article

SN - 2044-6055

VL - 11

JO - BMJ Open

JF - BMJ Open

IS - 9

M1 - e048144

ER -

ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI

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