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


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
30 09 2021
Historique:
entrez: 1 10 2021
pubmed: 2 10 2021
medline: 21 10 2021
Statut: epublish

Résumé

The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI. 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. 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. ClinicalTrials.gov Registry (NCT04063566).

Identifiants

pubmed: 34593491
pii: bmjopen-2020-048144
doi: 10.1136/bmjopen-2020-048144
pmc: PMC8487192
doi:

Substances chimiques

Prostate-Specific Antigen EC 3.4.21.77

Banques de données

ClinicalTrials.gov
['NCT04063566']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e048144

Subventions

Organisme : Medical Research Council
ID : MC_UU_00004/01
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_00004/02
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_12023/28
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/R014043/1
Pays : United Kingdom

Informations de copyright

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

Déclaration de conflit d'intérêts

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.

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Auteurs

Teresa Marsden (T)

Division of Surgical and Interventional Sciences, University College London, London, UK teresa.marsden@ucl.ac.uk.
Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.

Derek J Lomas (DJ)

Department of Urology, Mayo Clinic, Rochester, New York, USA.

Neil McCartan (N)

Division of Surgical and Interventional Sciences, University College London, London, UK.
Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.

Joanna Hadley (J)

Division of Surgical and Interventional Sciences, University College London, London, UK.
Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.

Steve Tuck (S)

ReIMAGINE Consortium Patient Representative, University College London, London, UK.

Louise Brown (L)

MRC Clinical Trials Unit, University College London, London, UK.

Anna Haire (A)

School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.

Charlotte Louise Moss (CL)

School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.

Saran Green (S)

School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.

Mieke Van Hemelrijck (M)

School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.

Ton Coolen (T)

London Institute for Mathematical Sciences, London, UK.

Aida Santaolalla (A)

Cancer Epidemiology Group, Division of Cancer Studies, King's College London, London, UK.

Elizabeth Isaac (E)

Centre for Medical Imaging, University College London, London, UK.

Giorgio Brembilla (G)

Centre for Medical Imaging, University College London, London, UK.

Douglas Kopcke (D)

Department of Radiology, University College London Hospitals NHS Foundation Trust, London, UK.

Francesco Giganti (F)

Division of Surgical and Interventional Sciences, University College London, London, UK.
Department of Radiology, University College London Hospitals NHS Foundation Trust, London, UK.

Harbir Sidhu (H)

Centre for Medical Imaging, University College London, London, UK.

Shonit Punwani (S)

Centre for Medical Imaging, University College London, London, UK.

Mark Emberton (M)

Division of Surgical and Interventional Sciences, University College London, London, UK.
Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.

Caroline M Moore (CM)

Division of Surgical and Interventional Sciences, University College London, London, UK.
Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK.

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Classifications MeSH