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).

Keywords: epidemiology; magnetic resonance imaging; prostate disease; urological tumours.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

ReIMAGINE Screening Study invitation to participate. Potential participants were identified through searchable databases at partner GP surgeries participating in the study and acting as participant identification centres (PICs). Invitation letters were sent out by each PIC using a docmail account (http://www.docmail.co.uk/) in batches of 50–100, to randomly selected eligible men, until 300 men had had their MRI scan. The invitation letter included contact details for study staff. Interested men were asked to contact the team to complete formal eligibility screening and enrol to the study. The template letter of invitation distributed by PICs is included in this figure. GP, general practitioner.

Figure 2

ReIMAGINE Screening Study eligibility and MRI safety checklist. Following an invitation letter, interested men were invited to contact the ReIMAGINE Screening Study team either by telephone or email to complete formal eligibility screening according to the ReIMAGINE Screening Study eligibility and MRI safety checklist. This checklist was used to pre-screen for exclusion criteria not identified by initial searches at partner GP practices, to ensure it was safe to proceed with booking of the MRI scan and to confirm the responder was truly registered at one of the participating GP practices (confirmation was provided by the GP practice itself). From August 2020 onwards, this checklist was modified to include questions in relation to COVID-19 symptoms and testing. GP, general practitioner; IUD, intrauterine device; IVC, inferior vena cava; UCLH, University College London Hospital.

Figure 3

ReIMAGINE Prostate Cancer Screening Study flow. Invitations to participate in the study were sent to randomly selected, eligible men from collaborating general practice (GP) surgeries. Eligibility of responding men was confirmed during a telephone consult prior to recruitment. On the day of the study visit, men completed a study consent form, donated blood for PSA testing and underwent a ReIMAGINE Screening Study MRI of the prostate. Those who were screen negative exited the study. Screen positive participants were invited to undergo standard of care evaluation within an NHS prostate cancer clinic. eCRF, electronic case report form; NHS, National Health Service; PSA, prostate-specific antigen.

Figure 4

ReIMAGINE Screening Study MRI reporting sheets and electronic case report forms (CRFs). A standardised MRI reporting sheet was used by each reporter within the study. The primary reporter reported on the prostate volume, lesion presence, lesion location and scan quality. The second reporter reported a binary result of ‘screen positive’ or ‘screen negative’ only, but may also include clinical comments. CZ, central zone; NHS, National Health Service; PZ, peripheral zone; TZ, transition zone.