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

Authors :
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
Source :
BMJ Open, Vol 11, Iss 9 (2021)
Publication Year :
2021
Publisher :
BMJ Publishing Group, 2021.

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).

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
11
Issue :
9
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.2d020bf82ef2425ebb101ba2e49a621f
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2020-048144