ReIMAGINE Prostate Cancer Screening
Condition: Prostate Cancer Screening; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Magnetic Resonance Imaging (MRI); Prostate-specific antigen (PSA) test
Intervention type(s): Procedure; Procedure
Intervention description(s): Prostate cancer screening MRI; Blood test for PSA levels
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
Keywords: Prostate Cancer; MRI; PSA