ReIMAGINE Prostate Cancer Screening

• ClinicalTrials.gov Identifier: NCT04063566
• Recruitment Status: Completed
• First Posted: August 21, 2019
• Last Update Posted: October 15, 2021
• Sponsor: University College, London
• Collaborators: Medical Research Council; Cancer Research UK; Imperial College London; King's College London
• Information provided by (Responsible Party): University College, London

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer Screening; Prostate Cancer	Procedure: Magnetic Resonance Imaging (MRI); Procedure: Prostate-specific antigen (PSA) test	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 309 participants
• Allocation: N/A
• 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)
• Primary Purpose: Screening
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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

Secondary Outcome Measures :

1. 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
2. The proportion of men who screen negative on MRI [ Time Frame: 3 years ]
   The proportion of men who screen negative on MRI
3. The proportion of men who screen negative on PSA density [ Time Frame: 3 years ]
   The proportion of men who screen negative on PSA density
4. The proportion of men who screen positive on MRI alone [ Time Frame: 3 years ]
   The proportion of men who screen positive on MRI alone
5. 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

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United Kingdom

University College London Hospital

London, United Kingdom, NW1 2PG

Sponsors and Collaborators

University College, London

Medical Research Council

Cancer Research UK

Imperial College London

King's College London

Investigators

• Principal Investigator: Caroline Moore, FRCS; univeristy college london

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University College, London
• ClinicalTrials.gov Identifier: NCT04063566
• Other Study ID Numbers: 123874
• First Posted: August 21, 2019
• Last Update Posted: October 15, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University College, London:

Prostate Cancer; MRI; PSA

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases