ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI.
epidemiology
magnetic resonance imaging
prostate disease
urological tumours
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
30 09 2021
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
e048144Subventions
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.
Références
N Engl J Med. 2009 Mar 26;360(13):1310-9
pubmed: 19297565
Lancet. 2014 Dec 6;384(9959):2027-35
pubmed: 25108889
Lancet. 2017 Feb 25;389(10071):815-822
pubmed: 28110982
J Magn Reson Imaging. 2019 Sep;50(3):910-917
pubmed: 30566264
J Urol. 2016 Aug;196(2):361-6
pubmed: 26880413
N Engl J Med. 2018 May 10;378(19):1767-1777
pubmed: 29552975
JAMA. 2018 May 8;319(18):1914-1931
pubmed: 29801018
Eur Urol. 2019 Jul;76(1):43-51
pubmed: 30824296
JAMA. 2018 Mar 6;319(9):883-895
pubmed: 29509864
J Urol. 2020 Apr;203(4):706-712
pubmed: 31642740
Eur Urol. 2019 Apr;75(4):570-578
pubmed: 30477981
Lancet Oncol. 2019 Jan;20(1):100-109
pubmed: 30470502
JAMA Oncol. 2021 Mar 1;7(3):395-402
pubmed: 33570542
JAMA Oncol. 2021 Apr 1;7(4):534-542
pubmed: 33538782
Eur Urol. 2019 Dec;76(6):790-813
pubmed: 31587989