Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT05608694
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2022-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Screening in Men at High Risk of Developing Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2039-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-11-02', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2037-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with high grade prostate cancer detection.', 'timeFrame': 'Every 3 years up to 15 years', 'description': 'MRI results will be collected every 3 years for 15 years until high grade prostate cancer is detected as defined as Gleason greater than or equal to 7 (Grade Group 2).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer Screening']}, 'referencesModule': {'references': [{'pmid': '38576242', 'type': 'BACKGROUND', 'citation': 'Fazekas T, Shim SR, Basile G, Baboudjian M, Koi T, Przydacz M, Abufaraj M, Ploussard G, Kasivisvanathan V, Rivas JG, Gandaglia G, Szarvas T, Schoots IG, van den Bergh RCN, Leapman MS, Nyirady P, Shariat SF, Rajwa P. Magnetic Resonance Imaging in Prostate Cancer Screening: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jun 1;10(6):745-754. doi: 10.1001/jamaoncol.2024.0734.'}, {'pmid': '39321360', 'type': 'BACKGROUND', 'citation': 'Hugosson J, Godtman RA, Wallstrom J, Axcrona U, Bergh A, Egevad L, Geterud K, Khatami A, Socratous A, Spyratou V, Svensson L, Stranne J, Mansson M, Hellstrom M. Results after Four Years of Screening for Prostate Cancer with PSA and MRI. N Engl J Med. 2024 Sep 26;391(12):1083-1095. doi: 10.1056/NEJMoa2406050.'}, {'pmid': '38648061', 'type': 'BACKGROUND', 'citation': 'Bjornebo L, Discacciati A, Falagario U, Vigneswaran HT, Jaderling F, Gronberg H, Eklund M, Nordstrom T, Lantz A. Biomarker vs MRI-Enhanced Strategies for Prostate Cancer Screening: The STHLM3-MRI Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247131. doi: 10.1001/jamanetworkopen.2024.7131.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether or not Magnetic Resonance Images (MRI) will identify high-grade cancers earlier and more frequently in men at high risk of developing prostate cancer.', 'detailedDescription': 'In this study the study team hypothesizes MR images will identify high-grade cancers earlier and more frequently in men at high risk of developing prostate cancer. Subjects will receive gadolinium (intravenous contrast agent) as part of their research MRI exam. While the deposition of gadolinium (Gd) has been demonstrated in numerous studies, the clinical consequences of Gd deposition are unknown. Gd enhanced MRI scans provide crucial medical information regarding prostate and prostate cancer imaging and contrast-enhanced images are a component of all guidelines and the PIRADS scoring system. The study team will compare baseline prostate MR images of men at high risk of developing prostate cancer to those without an identifiable predisposition and evaluate the role of a GRS in screening men with at elevated risk of being diagnosed with prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male age 18 and older\n* No known history of prostate cancer\n* No previous prostate resection or ablation (e.g. TURP, photovaporization)\n\nExclusion Criteria:\n\n* Unable to tolerate MRI due to metal fragments or claustrophobia\n* Lack of a rectum\n* Hip arthroplasty'}, 'identificationModule': {'nctId': 'NCT05608694', 'briefTitle': 'MRI Screening in Men at High Risk of Developing Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'MRI Screening in Men at High Risk of Developing Prostate Cancer', 'orgStudyIdInfo': {'id': 'IRB20-0038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'High Risk- Positive Germline Mutation (n=40):', 'description': 'Men who harbor known germline mutations that have been associated with an increased risk of prostate cancer and aggressive disease (e.g. BRCA2, ATM, PALB2, etc.) with or without a known family history of prostate cancer.', 'interventionNames': ['Other: Prostate MRI']}, {'type': 'OTHER', 'label': 'High Risk- High GRS (n=40):', 'description': 'Men who harbor significantly increased disease risk based upon genetic risk score (GRS) value \\>1.5 with or without a known family history of prostate cancer.', 'interventionNames': ['Other: Prostate MRI']}, {'type': 'OTHER', 'label': 'High Risk- Family History (n=45):', 'description': 'Men with a family history of prostate cancer in at least one sibling, father, uncle, or grandfather but no known increased genetic risk of prostate cancer (has no pathogenic or likely pathogenic mutation along with a low genetic risk score (GRS\\<1.5).', 'interventionNames': ['Other: Prostate MRI']}, {'type': 'OTHER', 'label': 'Low Risk (n=125):', 'description': 'No known germline mutation, low genetic risk score (GRS \\<1.5), and no known family history of prostate cancer.', 'interventionNames': ['Other: Prostate MRI']}], 'interventions': [{'name': 'Prostate MRI', 'type': 'OTHER', 'description': 'Group placement is determined by GRS score, Family history, and germline testing', 'armGroupLabels': ['High Risk- Family History (n=45):', 'High Risk- High GRS (n=40):', 'High Risk- Positive Germline Mutation (n=40):', 'Low Risk (n=125):']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Eggener, MD', 'role': 'CONTACT', 'email': 'seggener@surgery.bsd.uchicago.edu', 'phone': '773-702-1001'}, {'name': 'Teresa Barry', 'role': 'CONTACT', 'email': 'tbarry@bsd.uchicago.edu', 'phone': '7737025681'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60026', 'city': 'Glenview', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pooja Talaty', 'role': 'CONTACT', 'email': 'ptalaty@northshore.org'}, {'name': 'Svetlana Brumer', 'role': 'CONTACT', 'email': 'sbrumer@northshore.org'}, {'name': 'Brian Helfand, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NorthShore University Health System - Glenbrook Hospital', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}], 'centralContacts': [{'name': 'Scott Eggener, MD', 'role': 'CONTACT', 'email': 'seggener@surgery.bsd.uchicago.edu', 'phone': '7737021001'}, {'name': 'Teresa Barry', 'role': 'CONTACT', 'email': 'tbarry@bsd.uchicago.edu'}], 'overallOfficials': [{'name': 'Scott Eggener, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}