protocolSection identificationModule nctId: NCT06280781, orgStudyIdInfo id: 22CX7971, secondaryIdInfos id: NIHR152027, type: OTHER_GRANT, domain: National Institute of Health Research - Health Technology Assessment, briefTitle: Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance), acronym: IP9-ATLAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2029-06, completionDateStruct date: 2032-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Imperial College Healthcare NHS Trust, class: OTHER, collaborators name: East London NHS Foundation Trust, collaborators name: King's College, collaborators name: University College, London, collaborators name: University of York, collaborators name: University College London Hospitals, descriptionModule briefSummary: 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., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: 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., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1263, type: ESTIMATED, armsInterventionsModule interventions name: MRI Scans, outcomesModule primaryOutcomes measure: Biopsy, primaryOutcomes measure: Staging, secondaryOutcomes measure: Cost-effectiveness, secondaryOutcomes measure: Biopsy Measurement, secondaryOutcomes measure: MRI & biopsy-related adverse events, secondaryOutcomes measure: Treatment, secondaryOutcomes measure: Compliance, secondaryOutcomes measure: EPIC Questionnaires, secondaryOutcomes measure: HADS Questionnaires, secondaryOutcomes measure: EQ-5D-5L Questionnaires, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-07, uploadDate: 2024-01-24T08:54, filename: Prot_SAP_000.pdf, size: 1231033, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-12-07, uploadDate: 2024-01-24T09:01, filename: ICF_001.pdf, size: 286927, hasResults: False