ReIMAGINE Prostate Cancer Screening

ReIMAGINE Prostate Cancer Screening - Inviting Men for Prostate Cancer Screening Using MRI

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Prostate Cancer Screening
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Prostate-specific antigen (PSA) test

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 Type: Interventional
• Enrollment (Actual): 309
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2PG
    • University College London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Total cohort; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of men ineligible due to prior prostate cancer diagnosis	The proportion of men ineligible due to prior prostate cancer diagnosis	3 years
The proportion of men who screen negative on MRI	The proportion of men who screen negative on MRI	3 years
The proportion of men who screen negative on PSA density	The proportion of men who screen negative on PSA density	3 years
The proportion of men who screen positive on MRI alone	The proportion of men who screen positive on MRI alone	3 years
The proportion of men who screen positive on PSA density alone	The proportion of men who screen positive on PSA density alone	3 years

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: King's College London; Imperial College London; Medical Research Council; Cancer Research UK
• Investigators: Principal Investigator: Caroline Moore, FRCS, Univeristy College London

Publications and helpful links

General Publications

• 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, 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: MRI; PSA; Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 123874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No