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ReIMAGINE Prostate Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04063566
Recruitment Status : Completed
First Posted : August 21, 2019
Last Update Posted : October 15, 2021
Sponsor:
Collaborators:
Medical Research Council
Cancer Research UK
Imperial College London
King's College London
Information provided by (Responsible Party):
University College, London

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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
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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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Caroline Moore, FRCS univeristy college london
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04063566    
Other Study ID Numbers: 123874
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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