ReIMAGINE Prostate Cancer Screening
Research type
Research Study
Full title
ReIMAGINE Prostate Cancer Screening – inviting men for prostate cancer screening using MRI
IRAS ID
251167
Contact name
Caroline Moore
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/05/172 , UCL Data Protection reference
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
This is a single site study to assess the feasibility of MRI as a screening tool for prostate care and determine the prevalence of MRI defined suspicious lesions in men across a spectrum of PSA results.
Men with no previous prostate cancer diagnosis, but deemed suitable based on age will be identified through GP practices. Potential participants will be identified through screening of existing patient databases at multiple London GP practices, and randomly selected for invitation.
Personalised invitation letters from each man’s own GP will be sent in batches until a response rate is known. Invitation letters will include contact details for the ReIMAGINE study team who will coordinate the booking of a research visit which should take no more than 1 hour.
At this visit we will:
• Collect information on their medical history.
• Collect a blood sample to measure the amount of PSA in their blood. (a protein produced by normal cells in the prostate and also by prostate cancer cells)
• Undertake an MRI scan of their pelvic area (short scan taking up to 20minutes)The MRI will be reported by two radiologists and the results reported to the researcher. The researcher will review the MRI reports and the PSA value to determine if a participant is deemed ‘screen negative’ or ‘screen positive’.
Men in whom a suspicious lesion is seen (MRI screen positive) or who have a suspicious PSA density (>0.12ng/ml) will be recommended to have an NHS referral for urgent suspected prostate cancer as per NICE guidelines.
Screen negative men will at this point exit the study. Screen positive men will be followed up for up to 3 months so to gather data from any investigations that may occur as a result of the NHS referral. No formal visits will be required to collect this data.REC name
London - Stanmore Research Ethics Committee
REC reference
19/LO/1129
Date of REC Opinion
29 Jul 2019
REC opinion
Further Information Favourable Opinion