Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT05384535
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2022-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2022-05-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml', 'timeFrame': '3 months', 'description': 'To determine the incidence of positive mpMRI prostate in a high-risk cohort of men as a screening tool for prostate cancer.'}], 'secondaryOutcomes': [{'measure': 'Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI', 'timeFrame': '3 months', 'description': 'Proportion of men with suspicious lesion found to have cancer on biopsy, this is the PPV based on the prevalence of this population.'}, {'measure': 'Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer.', 'timeFrame': '5 years', 'description': 'Proportion diagnosed with prostate cancer over 5 year follow-up among patients who were not diagnosed with prostate cancer based on findings of initial mpMRI (i.e. mend who either did not have any suspicious lesions or had suspicious lesions but were negative for cancer on biopsy)'}, {'measure': 'To correlate bpMRI findings with future changes in PSA', 'timeFrame': '5 years', 'description': 'PSA density will be measured every year for five years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Screening', 'Magnetic Resonance Imaging'], 'conditions': ['Prostate Cancer', 'Magnetic Resonance Imaging', 'Population at Risk']}, 'referencesModule': {'references': [{'pmid': '29203269', 'type': 'BACKGROUND', 'citation': 'Sanda MG, Cadeddu JA, Kirkby E, Chen RC, Crispino T, Fontanarosa J, Freedland SJ, Greene K, Klotz LH, Makarov DV, Nelson JB, Rodrigues G, Sandler HM, Taplin ME, Treadwell JR. 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Epub 2010 Dec 16.'}, {'pmid': '31158230', 'type': 'BACKGROUND', 'citation': 'Jambor I, Verho J, Ettala O, Knaapila J, Taimen P, Syvanen KT, Kiviniemi A, Kahkonen E, Perez IM, Seppanen M, Rannikko A, Oksanen O, Riikonen J, Vimpeli SM, Kauko T, Merisaari H, Kallajoki M, Mirtti T, Lamminen T, Saunavaara J, Aronen HJ, Bostrom PJ. Validation of IMPROD biparametric MRI in men with clinically suspected prostate cancer: A prospective multi-institutional trial. PLoS Med. 2019 Jun 3;16(6):e1002813. doi: 10.1371/journal.pmed.1002813. eCollection 2019 Jun.'}, {'pmid': '33219368', 'type': 'BACKGROUND', 'citation': 'Bass EJ, Pantovic A, Connor M, Gabe R, Padhani AR, Rockall A, Sokhi H, Tam H, Winkler M, Ahmed HU. A systematic review and meta-analysis of the diagnostic accuracy of biparametric prostate MRI for prostate cancer in men at risk. Prostate Cancer Prostatic Dis. 2021 Sep;24(3):596-611. doi: 10.1038/s41391-020-00298-w. Epub 2020 Nov 20.'}, {'pmid': '34893859', 'type': 'BACKGROUND', 'citation': 'Qiao EM, Lynch JA, Lee KM, Kotha NV, Nalawade V, Voora RS, Qian AS, Nelson TJ, Yamoah K, Garraway IP, Stewart TF, Parsons JK, Rose BS. Evaluating Prostate-Specific Antigen Screening for Young African American Men With Cancer. J Natl Cancer Inst. 2022 Apr 11;114(4):592-599. doi: 10.1093/jnci/djab221.'}], 'seeAlsoLinks': [{'url': 'https://www.fda.gov/media/71385/download', 'label': 'Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices'}, {'url': 'http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm055910.htm', 'label': 'Medical Device Regulation and Overview General and Special Controls'}, {'url': 'http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm', 'label': 'How to Market Your Device'}, {'url': 'http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053156.htm', 'label': 'How to market Your Device (2)'}, {'url': 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm', 'label': 'Accessing Data'}, {'url': 'http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm', 'label': 'Post Market Regulation Requirements'}]}, 'descriptionModule': {'briefSummary': 'To determine whether using bpMRI in subjects who are at high risk of developing prostate cancer in conjunction with PSA will improve prostate cancer screening protocols.', 'detailedDescription': 'The Investigators propose a pilot study which utilizes bpMRI in conjunction with PSA in the early detection of clinically significant prostate cancer in a high-risk group. Our study would focus on these high-risk subjects between the ages of 40-55 with a normal PSA ranging from ≥1.0 to \\<2.5 ng/mL. bpMRI would be obtained in this group of subjects. If any suspicious lesions are found, the recommendation is to undergo MRI/US fusion biopsy. Subjects with negative bpMRI will be followed every year with serum PSA. Subjects with a positive bpMRI will have a prostate fusion and systematic biopsy performed. Those with a benign biopsy will be followed every year with serum PSA. Those who have a biopsy positive for cancer will be managed and followed according to the standard of care. All subjects will be followed for 5 years. Our hypothesis is that bpMRI in conjunction with above average PSA in a high-risk group will increase detection of clinically relevant prostate cancer and provide a useful addition to PSA screening.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. PSA between 1.0 and 2.5 ng/dL\n2. High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2\n3. Patient is willing to participated in prostate cancer screening\n4. Patient is capable of giving informed consent\n\nExclusion Criteria:\n\n1. Nodularity or firmness of prostate on exam\n2. Patient has undergone a prior biopsy or prostate surgery\n3. Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.\n4. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.\n5. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies\n6. Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner\n7. The participant cannot tolerate lying flat for the study duration'}, 'identificationModule': {'nctId': 'NCT05384535', 'briefTitle': 'Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort', 'orgStudyIdInfo': {'id': '21-1380'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bi-parametric Screening MRI', 'description': 'Bi-parametric MRI to be administered to High Risk males', 'interventionNames': ['Diagnostic Test: Bi-parametric MRI']}], 'interventions': [{'name': 'Bi-parametric MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'When used for the evaluation of prostate cancer, MRI typically involves multiple sequences and typically includes typical T1 and T2 phases with the addition of diffusion weighted imaging and dynamic contrast enhanced imaging. In this study, we have decided to omit dynamic contrast enhanced imaging due to its decreased diagnostic yield relative to T2 and DWI and associated increased risk of contrast agents, this is a common approach for prostate cancer screening and is referred to as a bi-parametric MRI', 'armGroupLabels': ['Bi-parametric Screening MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cynthia Knauer', 'role': 'CONTACT', 'email': 'urologyresearch@northwell.edu', 'phone': '516-734-8500'}, {'name': 'Monica Johnson', 'role': 'CONTACT', 'email': 'urologyresesearch@northwell.edu', 'phone': '516-734-8500'}, {'name': 'Ardeshir Rastinehad, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Manish Vira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cynthia Knauer', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}], 'centralContacts': [{'name': 'Cynthia Knauer, RN', 'role': 'CONTACT', 'email': 'urologyresearch@northwell.edu', 'phone': '516-734-8500'}, {'name': 'Monica Johnson', 'role': 'CONTACT', 'email': 'urologyresearch@northwell.edu', 'phone': '516-734-8500'}], 'overallOfficials': [{'name': 'Ardeshir Rastinehad, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}, {'name': 'Manish Vira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share IPD with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}