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A Randomised Controlled Trial of Regular MRI Scans Compared to Standard Care in Patients With Prostate Cancer Managed Using Active Surveillance

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Heatherwood Hospital
RECRUITING
Ascot
Bradford Royal Infirmary
RECRUITING
Bradford
St Peter's Hospital
RECRUITING
Chertsey
Darent Valley Hospital
RECRUITING
Dartford
Charing Cross Hospital
RECRUITING
London
Kings College London
RECRUITING
London
West Middlesex Hospital
RECRUITING
London
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Glan Clywd Hospital
RECRUITING
Rhyl
Northern Lincolnshire and Goole NHS Foundation Trust
RECRUITING
Scunthorpe
Southampton University Hospital
RECRUITING
Southampton
North Cumbria
RECRUITING
Whitehaven
Contact Information
Primary
Hashim Ahmed
hashim.ahmed@imperial.ac.uk
+44 (0)20 7594 1660
Backup
Increase Akinyemi
i.akinyemi@imperial.ac.uk
+447731513982
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2032-06
Participants
Target number of participants: 1263
Treatments
No_intervention: Standard care (Control) Arm
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.
Experimental: Intervention Arm
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.
Related Therapeutic Areas
Sponsors
Collaborators: Queen Mary University of London, University of Leeds, University of York, University College, London, University College London Hospitals
Leads: Imperial College London

This content was sourced from clinicaltrials.gov