NCT06280781 Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)
| NCT ID | NCT06280781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,263 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,263 participants in total. It began in 2024-05-24 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06280781 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06280781 currently recruiting?
Yes, NCT06280781 is actively recruiting participants. Contact the research team at hashim.ahmed@imperial.ac.uk for enrollment information.
Where is the NCT06280781 trial being conducted?
This trial is being conducted at Ascot, United Kingdom, Dartford, United Kingdom, Bradford, United Kingdom, Chertsey, United Kingdom and 8 additional locations.
Who is sponsoring the NCT06280781 clinical trial?
NCT06280781 is sponsored by Imperial College London. The trial plans to enroll 1,263 participants.
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