RecruitingNot ApplicableNCT06280781

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


Sponsor

Imperial College London

Enrollment

1,263 participants

Start Date

May 24, 2024

Study Type

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The ATLAS study is following men with localized prostate cancer who have chosen active surveillance — a careful monitoring approach rather than immediate treatment. The study aims to find the best long-term monitoring strategy to safely track the cancer and decide if and when treatment is needed. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with localized prostate cancer confirmed by biopsy - You have had an MRI scan of the prostate - You have chosen active surveillance as your management approach - You have been on active surveillance for less than 9 months **You may NOT be eligible if...** - You have been on active surveillance for more than 9 months before the study screening date - You have a contraindication to MRI or gadolinium contrast dye - You have had both hips replaced (interferes with imaging) - You cannot have a transrectal ultrasound-guided biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TESTMRI 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06280781


Related Trials