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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorImperial College London

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MRI Scans

Treatment groups

1,263 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Imperial College London

Lead sponsor

Queen Mary University of London

Collaborator

University of Leeds

Collaborator

University College, London

Collaborator

University of York

Collaborator

University College London Hospitals

Collaborator