Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-29 @ 12:12 AM
Study NCT ID:
NCT07155759
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes of Prostate Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes are verified through national registers'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7500}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2035-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prostate cancer mortality', 'timeFrame': '5-10 years', 'description': 'Mortality from prostate cancer (yes/no)'}, {'measure': 'Detection of clinically significant prostate cancer', 'timeFrame': '1-3 years', 'description': 'Gleason Score ≥7 disease detected (Yes/No)'}], 'secondaryOutcomes': [{'measure': 'Prostate cancer metastasis-free survival', 'timeFrame': '5-10 years'}, {'measure': 'Detection of prostate cancer by grade', 'timeFrame': '1-3 years', 'description': 'ISUP (International Society of UroPathology) grade group 1-5'}, {'measure': 'Performed prostate biopsy', 'timeFrame': '1-3 years', 'description': 'Participant undergone a biopsy procedure of the prostate (Yes/No)'}, {'measure': 'Performed MRI of prostate', 'timeFrame': '1-3 years'}, {'measure': 'Grading of MRI prostate', 'timeFrame': '1-3 years', 'description': 'PI-RADS (Prostate Imaging Reporting and Data System (PI-RADS)\n\n) score (1-5)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening', 'magnetic resonance imaging', 'biomarker', 'mortality', 'stockholm3'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study is an expansion of the screening-by-invitation STHLM3MRI trial for detection of prostate cancer. In summary, we assess longterm outcomes (prostate cancer mortality, incidence and resource use) in men (i) invited and randomized to a screening program using PSA, a biomarker test and MRI; (ii) invited and randomized to a single PSA test with prostate biopsies followed by opportunistic testing and (iii) population controls. Mortality is verified through register data, disease verification is made through in-study biopsy results and registry data.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligible participants:\n\n-Men eligible for the longterm f/u-study arms (experimental and control) are participants in the STHLM3MRI trial.\n\nInclusion Criteria:\n\n* Men age 50-74 years without prior diagnosis of prostate cancer (ICD-9 C61).\n* Permanent postal address in Stockholm\n* Not a previous participant in the Stockholm3 study (2012-2014)\n\nExclusion Criteria:\n\n* Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia\n* Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.\n* Men with a previous prostate biopsy the preceding 60 days before invitation.'}, 'identificationModule': {'nctId': 'NCT07155759', 'acronym': 'STHLM3MRI_3', 'briefTitle': 'Long-term Outcomes of Prostate Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Long-term Outcomes of Prostate Cancer Screening Using PSA, Biomarkers and MRI: The STHLM3MRI Trial', 'orgStudyIdInfo': {'id': 'STHLM3MRI_3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Organized screening including repeat testing (MRI+biomarkers)', 'description': 'participants are offered prostate cancer screening. Interventions are (i) a paired PSA and Stockholm3 bloodtest; (ii) if elevated (PSA\\>=3 \\| Stockholm3\\>=0.11), an MRI is offered. If MRI shows PI-RADS≥3, prostate biopsies are offered. Screenings are offered at year 0, year 2-3 (if original PSA≥1.5) and year 6', 'interventionNames': ['Diagnostic Test: PSA/Stockholm3/MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'One-time invitation to testing arm (traditional biopsies)', 'description': 'participants are offered prostate cancer screening. interventions are a PSA bloodtest. If PSA≥3 ng/ml, a standard prostate biopsy is offered. No repeat screenings are offered.', 'interventionNames': ['Diagnostic Test: PSA']}, {'type': 'NO_INTERVENTION', 'label': 'Population controls', 'description': 'Population controls are identified through registers and followed in national outcome registers (Swedish Board of Health and Welfare)'}], 'interventions': [{'name': 'PSA/Stockholm3/MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Stockholm3+PSA followed by MRI of the prostate', 'armGroupLabels': ['Organized screening including repeat testing (MRI+biomarkers)']}, {'name': 'PSA', 'type': 'DIAGNOSTIC_TEST', 'description': 'PSA followed by standard biopsies', 'armGroupLabels': ['One-time invitation to testing arm (traditional biopsies)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Tobias Nordström, Ass Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '24 months from publication of first main manuscript of the project', 'ipdSharing': 'YES', 'description': 'Individual participant data underlying the results reported in this project will be available after deidentification, together with the study protocol, statistical analysis plan, and analytic code. Data will be made available to researchers who provide a methodologically robust proposal, in which the aims are relevant and clear. Proposals can be submitted up to 24 months after publication of the first main article of the project and should be directed to tobias.nordstrom@ki.se. Only proposals with ethical approval will be granted access to the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Cancer Foundation', 'class': 'OTHER'}, {'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Consultant Urologist', 'investigatorFullName': 'Tobias Nordström', 'investigatorAffiliation': 'Karolinska Institutet'}}}}