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

BMJ Open. 2021 Sep 30;11(9):e048144. doi: 10.1136/bmjopen-2020-048144.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Early Detection of Cancer
  • Feasibility Studies
  • Humans
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Prospective Studies
  • Prostate-Specific Antigen*
  • Prostatic Neoplasms* / diagnostic imaging
  • State Medicine

Substances

  • Prostate-Specific Antigen

Associated data

  • ClinicalTrials.gov/NCT04063566