About this trial
The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.
Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?
Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories \[ no visible lesion, diffuse changes, discrete visible lesion\]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians.
Eligibility criteria
Qualifiers
Age 18 years or above (no upper limit)
Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).
Diagnostic bi-parametric or multiparametric MRI
Diagnostic systematic biopsy +/- targeted biopsy
Disqualifiers
On active surveillance for greater than 9 months prior to screening date.
Contraindication to MRI or gadolinium contrast
Previous hip replacement to both hips
Contraindication to performing a biopsy guided by a transrectal ultrasound probe
Trial design
Treatments tested in this trial
- MRI Scans
Treatment groups
Sponsors and collaborators
Imperial College London
Lead sponsor
Queen Mary University of London
Collaborator
University of Leeds
Collaborator
University College, London
Collaborator
University of York
Collaborator
University College London Hospitals
Collaborator