ReIMAGINE Prostate Cancer Screening
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|ClinicalTrials.gov Identifier: NCT04063566|
Recruitment Status : Completed
First Posted : August 21, 2019
Last Update Posted : October 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Screening Prostate Cancer||Procedure: Magnetic Resonance Imaging (MRI) Procedure: Prostate-specific antigen (PSA) test||Not Applicable|
ReIMAGINE Prostate cancer screening is a single site screening study to assess the feasibility of MRI as a screening tool for prostate care and determine the prevalence of MRI defined suspicious lesions and cancer 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||309 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single site screening study to assess the feasibility of MRI as a screening tool for prostate care and determine the prevalence of MRI defined suspicious lesions and cancer in men across a spectrum of PSA results.|
|Masking:||None (Open Label)|
|Official Title:||ReIMAGINE Prostate Cancer Screening - Inviting Men for Prostate Cancer Screening Using MRI|
|Actual Study Start Date :||October 21, 2019|
|Actual Primary Completion Date :||July 30, 2021|
|Actual Study Completion Date :||September 30, 2021|
The study will consist of one group, one arm, all receiving the same screening procedures.
Procedure: Magnetic Resonance Imaging (MRI)
Prostate cancer screening MRI
Procedure: Prostate-specific antigen (PSA) test
Blood test for PSA levels
- The acceptance rate of an invitation for a screening prostate MRI in men who have not had a prostate cancer diagnosis [ Time Frame: 3 years ]Proportion of men who accept the invitation for prostate screening
- The prevalence of MRI defined suspicious lesions in men accepting a screening invitation [ Time Frame: 3 years ]The prevalence of MRI defined suspicious lesions in men accepting a screening invitation
- Presence of cancer in men who have biopsy as a result of their MRI findings [ Time Frame: 3 years ]The prevalence of men being diagnosed with prostate cancer who have biopsy as a result of their MRI findings
- The proportion of men ineligible due to prior prostate cancer diagnosis [ Time Frame: 3 years ]The proportion of men ineligible due to prior prostate cancer diagnosis
- The proportion of men who screen negative on MRI [ Time Frame: 3 years ]The proportion of men who screen negative on MRI
- The proportion of men who screen negative on PSA density [ Time Frame: 3 years ]The proportion of men who screen negative on PSA density
- The proportion of men who screen positive on MRI alone [ Time Frame: 3 years ]The proportion of men who screen positive on MRI alone
- The proportion of men who screen positive on PSA density alone [ Time Frame: 3 years ]The proportion of men who screen positive on PSA density alone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063566
|University College London Hospital|
|London, United Kingdom, NW1 2PG|
|Principal Investigator:||Caroline Moore, FRCS||univeristy college london|