ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI
Mieke Van Hemelrijck,
Neil McCartan,
Louise Brown,
Mark Emberton,
Aida Santaolalla,
Charlotte Louise Moss,
Caroline M Moore,
Anna Haire,
Shonit Punwani,
Teresa Marsden,
Derek J Lomas,
Joanna Hadley,
Steve Tuck,
Saran Green,
Ton Coolen,
Elizabeth Isaac,
Giorgio Brembilla,
Douglas Kopcke,
Francesco Giganti,
Harbir Sidhu
Affiliations
Mieke Van Hemelrijck
Faculty of Life Sciences and Medicine, Translational Oncology and Urology Research, King’s College London, London, UK
Neil McCartan
Division of Surgery & Interventional Science, University College London, London, UK
Louise Brown
senior statistician
Mark Emberton
Urology, University College London Hospitals NHS Foundation Trust, London, UK
Aida Santaolalla
Translational Oncology and Urology Research (TOUR), Centre for Cancer, Society and Public Health, School of Cancer and Pharmaceutical Sciences, King`s College London, London, UK
Charlotte Louise Moss
Translational Oncology and Urology Research, King`s College London, London, UK
Caroline M Moore
Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK
Anna Haire
Translational Oncology and Urology Research, King`s College London, London, UK
Shonit Punwani
Centre for Medical Imaging, University College London, London, UK
Teresa Marsden
Division of Surgery & Interventional Science, University College London, London, UK
Derek J Lomas
Department of Urology, Mayo Clinic, Rochester, New York, USA
Joanna Hadley
Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK
Steve Tuck
Oxfordshire Prostate Cancer Support Group, Oxford, UK
Saran Green
Translational Oncology and Urology Research (TOUR), Centre for Cancer, Society and Public Health, School of Cancer and Pharmaceutical Sciences, King`s College London, London, UK
Ton Coolen
London Institute for Mathematical Sciences, London, UK
Elizabeth Isaac
Centre for Medical Imaging, University College London, London, UK
Giorgio Brembilla
Centre for Medical Imaging, University College London, London, UK
Douglas Kopcke
Centre for Medical Imaging, University College London, London, UK
Francesco Giganti
Division of Surgery & Interventional Science, University College London, London, UK
Harbir Sidhu
Centre for Medical Imaging, University College London, London, UK
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).
