NCT04063566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

August 15, 2019

Last Update Submit

October 8, 2021

Conditions

Prostate Cancer ScreeningProstate Cancer

Keywords

Prostate CancerMRIPSA

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • The proportion of men ineligible due to prior prostate cancer diagnosis

    3 years

  • The proportion of men who screen negative on MRI

    3 years

  • The proportion of men who screen negative on PSA density

    3 years

  • The proportion of men who screen positive on MRI alone

    3 years

  • The proportion of men who screen positive on PSA density alone

    3 years

Study Arms (1)

Total cohort

OTHER

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

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

Interventions

Magnetic Resonance Imaging (MRI)PROCEDURE

Prostate cancer screening MRI

Total cohort
Prostate-specific antigen (PSA) testPROCEDURE

Blood test for PSA levels

Total cohort

Eligibility Criteria

Age50 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men aged 50-75
  • No prior prostate cancer diagnosis / treatment
  • Willing and able to provide written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospital

London, NW1 2PG, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 39886504DERIVED

  • 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.

    PMID: 34593491DERIVED

  • 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.

    PMID: 34110033DERIVED

  • 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.

    PMID: 33896710DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance SpectroscopyProstate-Specific Antigen

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesKallikreinsSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesProstatic Secretory ProteinsSeminal Plasma ProteinsSeminal ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigens, NeoplasmAntigensBiological FactorsBiomarkers, TumorBiomarkers

Study Officials

  • Caroline Moore, FRCS

    univeristy college london

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 21, 2019

Study Start

October 21, 2019

Primary Completion

July 30, 2021

Study Completion

September 30, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)