Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)
Recruiting · NCT06280781 · Interventional (participants receive a specific treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- A histological diagnosis of localised prostate cancer
- Patient chosen active surveillance
Exclusion criteria
- 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
Where it is running
12 locations listed.
- Bradford Royal Infirmary - Bradford, United Kingdom
- St Peter's Hospital - Chertsey, United Kingdom
- Charing Cross Hospital - London, United Kingdom
- Kings College London - London, United Kingdom
- West Middlesex Hospital - London, United Kingdom
- Freeman Hospital - Newcastle upon Tyne, United Kingdom
- Glan Clywd Hospital - Rhyl, United Kingdom
- Northern Lincolnshire and Goole NHS Foundation Trust - Scunthorpe, United Kingdom
- Southampton University Hospital - Southampton, United Kingdom
- North Cumbria - Whitehaven, United Kingdom
- Heatherwood Hospital - Ascot, Berkshire, United Kingdom
- Darent Valley Hospital - Dartford, Kent, United Kingdom