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Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)

NCT06280781 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1263

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • Queen Mary University of London

    collaborator OTHER

  • University of Leeds

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • University of York

    collaborator OTHER

  • University College London Hospitals

    collaborator OTHER

  • Imperial College London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2029-06-30
Completion
2032-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06280781 on ClinicalTrials.gov