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Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)
Sponsor: Imperial College London
Summary
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.
Official title: A Randomised Controlled Trial of Regular MRI Scans Compared to Standard Care in Patients With Prostate Cancer Managed Using Active Surveillance
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1263
Start Date
2024-05-24
Completion Date
2032-06
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
MRI Scans
The regular use of MRI in active surveillance will lead to greater confidence in active surveillance for patients with low and medium risk prostate cancer. This is because such a strategy is likely to detect cancer progression earlier with fewer invasive biopsies. Those patients randomised to the intervention arm will have additional MRI scans. These will be non-contrast so there is no risk from having repeated 1-2 yearly injections of gadolinium contrast. Patients with contraindications to MRI will not be taking part in the study so will not be exposed to an unnecessary MRI. Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI annually. All other patients will undergo PSA 6 monthly and MRI in years 1, 3 and 5. In all patients, a targeted biopsy will be carried out if the MRI PRECISE score is \>/=4.
Locations (12)
Heatherwood Hospital
Ascot, Berkshire, United Kingdom
Darent Valley Hospital
Dartford, Kent, United Kingdom
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