ReIMAGINE Prostate Cancer Screening

Not Applicable

Completed

• Conditions: Prostate Cancer Screening; Prostate Cancer
• Interventions: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Prostate-specific antigen (PSA) test

• Registration Number: NCT04063566
• Lead Sponsor: University College, London

Brief Summary

Single site study to assess the feasibility of prostate cancer screening using an invitation for a prostate MRI scan via GP practices. This feasibility study will assess the acceptability of an MRI as a prostate cancer screening assessment and assess the prevalence of MRI defined suspicious lesions and cancer in men across a spectrum of PSA results.

Detailed Description

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 Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Study Start: 2019-10-21
• Primary Completion: 2021-07-30
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 309

Inclusion Criteria

1. Men aged 50-75
2. No prior prostate cancer diagnosis / treatment
3. Willing and able to provide written informed consent.

Exclusion Criteria

1. Contraindication for MRI scanning (as assessed by the MRI safety questionnaire of the PET/MRI department) which includes but is not limited to: Intracranial aneurysm clips or other metallic objects; Intra-orbital metal fragments that have not been removed; Pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves; Inner ear implants; and History of claustrophobia
2. Men who require assisted living e.g. care home living
3. Dementia or other neurological condition meaning participant lacks the capacity to consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Total cohort	Prostate-specific antigen (PSA) test	The study will consist of one group, one arm, all receiving the same screening procedures.
Total cohort	Magnetic Resonance Imaging (MRI)	The study will consist of one group, one arm, all receiving the same screening procedures.

Primary Outcome Measures

Name	Time	Method
Presence of cancer in men who have biopsy as a result of their MRI findings	3 years	The prevalence of men being diagnosed with prostate cancer who have biopsy as a result of their MRI findings
The acceptance rate of an invitation for a screening prostate MRI in men who have not had a prostate cancer diagnosis	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	3 years	The prevalence of MRI defined suspicious lesions in men accepting a screening invitation

Secondary Outcome Measures

Name	Time	Method
The proportion of men who screen positive on MRI alone	3 years	The proportion of men who screen positive on MRI alone
The proportion of men who screen negative on MRI	3 years	The proportion of men who screen negative on MRI
The proportion of men ineligible due to prior prostate cancer diagnosis	3 years	The proportion of men ineligible due to prior prostate cancer diagnosis
The proportion of men who screen positive on PSA density alone	3 years	The proportion of men who screen positive on PSA density alone
The proportion of men who screen negative on PSA density	3 years	The proportion of men who screen negative on PSA density

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, United Kingdom