Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)
A Randomised Controlled Trial of Regular MRI Scans Compared to Standard Care in Patients With Prostate Cancer Managed Using Active Surveillance
Imperial College London
1,263 participants
May 24, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria4
- 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
Interventions
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(3)
View Full Details on ClinicalTrials.gov
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NCT06280781