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

Tracking Information

• First Submitted Date: August 15, 2019
• First Posted Date: August 21, 2019
• Last Update Posted Date: October 15, 2021
• Actual Study Start Date: October 21, 2019
• Actual Primary Completion Date: July 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2019)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 20, 2019)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ReIMAGINE Prostate Cancer Screening
• Official Title: ReIMAGINE Prostate Cancer Screening - Inviting Men for Prostate Cancer Screening Using MRI
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Prostate Cancer Screening
• Prostate Cancer

Intervention

• Procedure: Magnetic Resonance Imaging (MRI)
  Prostate cancer screening MRI
• Procedure: Prostate-specific antigen (PSA) test
  Blood test for PSA levels

Study Arms

Total cohort

The study will consist of one group, one arm, all receiving the same screening procedures.

Interventions:

• Procedure: Magnetic Resonance Imaging (MRI)
• Procedure: Prostate-specific antigen (PSA) test

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 8, 2021): 309
• Original Estimated Enrollment (submitted: August 20, 2019): 300
• Actual Study Completion Date: September 30, 2021
• Actual Primary Completion Date: July 30, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 50 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04063566
• Other Study ID Numbers: 123874
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University College, London
• Original Responsible Party: Same as current
• Current Study Sponsor: University College, London
• Original Study Sponsor: Same as current

Collaborators

• Medical Research Council
• Cancer Research UK
• Imperial College London
• King's College London

Investigators

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

• PRS Account: University College, London
• Verification Date: October 2021