Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
309 participants
INTERVENTIONAL
2019-10-21
2021-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Men with no previous prostate cancer diagnosis, but deemed suitable based on age will be identified through general practitioner (GP) practices who will act as participant identification centres (PIC's). Potential participants will be identified through screening of existing patient databases at multiple London GP surgeries participating in the study, and randomly selected for invitation. The ReIMAGINE study team will link with London cancer networks and Noclor research support (https://www.noclor.nhs.uk/) who will make first contact with potentially eligible men.
A personalised invitation letter from each man's own GP will be sent to him. Invitation letters will be sent in batches so to limit the time between the invitation and their study visit. Batched invitations will be prepared using an iterative process so to allow the study team to assess uptake rates and limit the gap between invitation and study visits.
Invitation letters will include contact details for the ReIMAGINE study team who will coordinate bookings for research visits for all responders.
All consented men will have a blood test for PSA and a screening MRI scan. This will take a maximum of 20 minutes, and will include T2, diffusion and research specific sequences.
Two radiologists will report the MRI blinded to the PSA result, with a third reviewer when there is disagreement between reporters. 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 National Health Service (NHS) referral for suspected prostate cancer as per National Institute for Health and Care Excellence (NICE) guidelines.
Screen negative men will at this point exit the study. Screen positive men will be followed up to gather data from any investigations (mpMRI +/- prostate biopsy) that may occur as a result of the NHS referral. No formal visits will be required to collect this data. Participant consent will be sought to approach GP or other secondary care centre.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Total cohort
The study will consist of one group, one arm, all receiving the same screening procedures.
Magnetic Resonance Imaging (MRI)
Prostate cancer screening MRI
Prostate-specific antigen (PSA) test
Blood test for PSA levels
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnetic Resonance Imaging (MRI)
Prostate cancer screening MRI
Prostate-specific antigen (PSA) test
Blood test for PSA levels
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. No prior prostate cancer diagnosis / treatment
3. Willing and able to provide written informed consent.
Exclusion Criteria
2. Men who require assisted living e.g. care home living
3. Dementia or other neurological condition meaning participant lacks the capacity to consent.
50 Years
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Research Council
OTHER_GOV
Cancer Research UK
OTHER
Imperial College London
OTHER
King's College London
OTHER
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Caroline Moore, FRCS
Role: PRINCIPAL_INVESTIGATOR
univeristy college london
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University College London Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Moore CM, Frangou E, McCartan N, Santaolalla A, Kopcke D, Brembilla G, Hadley J, Giganti F, Marsden T, Van Hemelrijck M, Gong F, Freeman A, Haider A, Tuck S, Pashayan N, Callender T, Green S, Brown LC, Punwani S, Emberton M. Prevalence of MRI lesions in men responding to a GP-led invitation for a prostate health check: a prospective cohort study. BMJ Oncol. 2023 Aug 21;2(1):e000057. doi: 10.1136/bmjonc-2023-000057. eCollection 2023.
Marsden T, Lomas DJ, McCartan N, Hadley J, Tuck S, Brown L, Haire A, Moss CL, Green S, Van Hemelrijck M, Coolen T, Santaolalla A, Isaac E, Brembilla G, Kopcke D, Giganti F, Sidhu H, Punwani S, Emberton M, Moore CM; ReIMAGINE Study Group. 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.
Wurnschimmel C, Kachanov M, Wenzel M, Mandel P, Karakiewicz PI, Maurer T, Steuber T, Tilki D, Graefen M, Budaus L. Twenty-year trends in prostate cancer stage and grade migration in a large contemporary german radical prostatectomy cohort. Prostate. 2021 Sep;81(12):849-856. doi: 10.1002/pros.24181. Epub 2021 Jun 10.
Marsden T, McCartan N, Hadley J, Tuck S, Brown L, Haire AJ, Moss CL, Green S, Van Hemelrijck M, Coolen T, Santaolalla A, Isaac E, Brembilla G, Kopcke D, Giganti F, Sidhu H, Punwani S, Emberton M, Moore CM; ReIMAGINE Study Group. Update from the ReIMAGINE Prostate Cancer Screening Study NCT04063566: Inviting Men for Prostate Cancer Screening Using Magnetic Resonance Imaging. Eur Urol Focus. 2021 May;7(3):503-505. doi: 10.1016/j.euf.2021.03.027. Epub 2021 Apr 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
123874
Identifier Type: -
Identifier Source: org_study_id