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

NCT06280781 | Recruiting DMC

• 2 other identifiers: 22CX7971NIHR152027
• Study Type: interventional
• Target: 1,263
• Locations: 1 country
• Sites: 12

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Biopsy

  Progression in each group defined as higher risk cancer on biopsy (Grade Group \>/=3) Prostate cancer progression rates and time to progression in each randomised arm defined on, • biopsy: grade progression to Grade Group 3 or greater or detection on biopsy of intraductal cancer or lymphovascular invasion. Many of our clinicians would include patients on active surveillance with cribriform pattern on Grade Group so this is not a factor for progression.

  5 Years

• Staging

  Progression in each group defined as higher risk cancer on higher stage (\>/=T3 or \>/=N or \>/=M1) over 5 years. Prostate cancer progression rates and time to progression in each randomised arm defined on, • staging: cancer has spread to surrounding tissues (extracapsular), lymph node involvement or distant body parts as demonstrated on cross-sectional imaging including MRI, CT, bone-scan or PET scans as deemed appropriate by the local multidisciplinary cancer team.

  5 Years

Secondary Outcomes (8)

• Cost-effectiveness

  5 Years

• Biopsy Measurement

  5 years

• MRI & biopsy-related adverse events

  5 Years

• Treatment

  5 Years

• Compliance

  5 Years

Study Arms (2)

Standard care (Control) Arm

NO INTERVENTION

PSA 3 monthly in year 1 and then 6 monthly with rectal exam annually if clinically indicated. MRI will be carried out at 12 months (if not had one at diagnosis). If a diagnostic MRI was carried out, a 12 month MRI scan will not be required. A biopsy will be required if indicated due to changes in rectal exam or PSA. Follow-up for 5 years.

Intervention Arm

EXPERIMENTAL

Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI scans annually. As per international PIRADS committee guidance the surveillance MRIs will be biparametric MRI scans which last approximately 15 minutes and exclude gadolinium contrast injection. 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.

Diagnostic Test: MRI Scans

Interventions

MRI Scans DIAGNOSTIC_TEST

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Due to disease type, prostate cancer is only found in male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Queen Mary University of London: collaborator
• University of Leeds: collaborator
• University College, London: collaborator
• University of York: collaborator
• University College London Hospitals: collaborator

Study Sites (12)

Heatherwood Hospital

Ascot, Berkshire, SL5 7GB, United Kingdom

RECRUITING

Darent Valley Hospital

Dartford, Kent, DA2 8DA, United Kingdom

RECRUITING

Bradford Royal Infirmary

Bradford, United Kingdom

RECRUITING

St Peter's Hospital

Chertsey, United Kingdom

RECRUITING

Charing Cross Hospital

London, W6 8RF, United Kingdom

RECRUITING

Kings College London

London, United Kingdom

RECRUITING

West Middlesex Hospital

London, United Kingdom

RECRUITING

Freeman Hospital

Newcastle upon Tyne, United Kingdom

RECRUITING

Glan Clywd Hospital

Rhyl, United Kingdom

RECRUITING

Northern Lincolnshire and Goole NHS Foundation Trust

Scunthorpe, United Kingdom

RECRUITING

Southampton University Hospital

Southampton, United Kingdom

RECRUITING

North Cumbria

Whitehaven, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Hashim Ahmed

CONTACT

+44 (0)20 7594 1660; hashim.ahmed@imperial.ac.uk

Increase Akinyemi

CONTACT

+447731513982; i.akinyemi@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Current (NICE defined active surveillance): PSA 3 monthly in year 1 and then 6 monthly with rectal exam annually. MRI will be carried out at 12 months (if not had one at diagnosis). A biopsy will be required if indicated due to changes in rectal exam or PSA. Planned (Regular MRI based active surveillance): 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.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 28, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2032
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

GB (12)