Prostate Cancer ScreeningNCT04063566
ReIMAGINE Prostate Cancer Screening
A study testing Magnetic Resonance Imaging (MRI) and Prostate-specific antigen (PSA) test in people with Prostate Cancer Screening and Prostate Cancer, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer Screening, Prostate Cancer
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Prostate-specific antigen (PSA) test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 50-75
- No prior prostate cancer diagnosis / treatment
- Willing and able to provide written informed consent.
Who cannot join
- 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
- Men who require assisted living e.g. care home living
- Dementia or other neurological condition meaning participant lacks the capacity to consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, NW1 2PG
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer Screening, Prostate Cancer
- Being tested
- Magnetic Resonance Imaging (MRI), Prostate-specific antigen (PSA) test
- Keywords
- Prostate Cancer, MRI, PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Procedure or surgery
Prostate cancer screening MRI
Prostate-specific antigen (PSA) testProcedure or surgery
Blood test for PSA levels
| Study group | Role | What they receive |
|---|---|---|
| Total cohort | Other | The study will consist of one group, one arm, all receiving the same screening procedures. Receives: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Prostate-specific antigen (PSA) test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 years
Secondary outcomes (5)
The proportion of men ineligible due to prior prostate cancer diagnosis
The proportion of men ineligible due to prior prostate cancer diagnosis
Measured: 3 years
The proportion of men who screen negative on MRI
The proportion of men who screen negative on MRI
Measured: 3 years
The proportion of men who screen negative on PSA density
The proportion of men who screen negative on PSA density
Measured: 3 years
The proportion of men who screen positive on MRI alone
The proportion of men who screen positive on MRI alone
Measured: 3 years
The proportion of men who screen positive on PSA density alone
The proportion of men who screen positive on PSA density alone
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start21 Oct 2019
- Primary completion30 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Cancer Research UK, Imperial College London, King's College London
- Responsible party
- Sponsor
- Investigators
- Caroline Moore, FRCS, Principal investigator, univeristy college london
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063566
- Sponsor's protocol ID
- 123874
- Status last verified
- Oct 2021
- First submitted
- 15 Aug 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore CM, Frangou E, McCartan N, Santaolalla A, Kopcke D, Brembilla G, Hadley J, Giganti F, Marsden T, Van Hemelrijck M, Gong F, Freeman A, Haider A, Tuck S, Pashayan N, Callender T, Green S, Brown LC, Punwani S, Emberton M. Prevalence of MRI lesions in men responding to a GP-led invitation for a prostate health check: a prospective cohort study. BMJ Oncol. 2023 Aug 21;2(1):e000057. doi: 10.1136/bmjonc-2023-000057. eCollection 2023.
PubMed 39886504Marsden 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.
PubMed 34593491Wurnschimmel 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.
PubMed 34110033Marsden 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.
PubMed 33896710
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReIMAGINE Prostate Cancer Screening - Inviting Men for Prostate Cancer Screening Using MRI
- ClinicalTrials.gov ID
- NCT04063566
- Acronym / sponsor ID
- 123874
- Conditions
- Prostate Cancer Screening, Prostate Cancer
- Keywords
- Prostate Cancer, MRI, PSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Cancer Research UK, Imperial College London, King's College London
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Total cohort | Other | Procedure: Magnetic Resonance Imaging (MRI), Procedure: Prostate-specific antigen (PSA) testThe study will consist of one group, one arm, all receiving the same screening procedures. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men aged 50-75
- No prior prostate cancer diagnosis / treatment
- Willing and able to provide written informed consent.
Key exclusion criteria (3 listed)
- 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
- Men who require assisted living e.g. care home living
- Dementia or other neurological condition meaning participant lacks the capacity to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Prostate cancer screening MRI | Procedure or surgery | Total cohort |
| Prostate-specific antigen (PSA) testBlood test for PSA levels | Procedure or surgery | Total cohort |
Primary outcome
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
5 secondary outcomes
The proportion of men ineligible due to prior prostate cancer diagnosis
Time frame: 3 years
The proportion of men who screen negative on MRI
Time frame: 3 years
The proportion of men who screen negative on PSA density
Time frame: 3 years
The proportion of men who screen positive on MRI alone
Time frame: 3 years
The proportion of men who screen positive on PSA density alone
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Derived from this study: PubMed 39886504Moore CM, Frangou E, McCartan N, Santaolalla A, Kopcke D, Brembilla G, Hadley J, Giganti F, Marsden T, Van Hemelrijck M, Gong F, Freeman A, Haider A, Tuck S, Pashayan N, Callender T, Green S, Brown LC, Punwani S, Emberton M. Prevalence of MRI lesions in men responding to a GP-led invitation for a prostate health check: a prospective cohort study. BMJ Oncol. 2023 Aug 21;2(1):e000057. doi: 10.1136/bmjonc-2023-000057. eCollection 2023.
- Derived from this study: PubMed 34593491Marsden 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.
- Derived from this study: PubMed 34110033Wurnschimmel 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.
- Derived from this study: PubMed 33896710Marsden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Moore, FRCS principal investigator
univeristy college london
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) and Prostate-specific antigen (PSA) test in people with Prostate Cancer Screening and Prostate Cancer, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04063566, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.