Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-02-09 @ 11:22 PM
Study NCT ID:
NCT03693703
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2018-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081364', 'term': 'Multiparametric Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 391}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2018-10-01', 'studyFirstSubmitQcDate': '2018-10-01', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection rate of bi-parametric MRI, and of mp-MRI in men at risk for PCa and with no previous prostate biopsy', 'timeFrame': '3 months', 'description': 'Sensitivity, specificity, PPV and NPV will be measured'}], 'secondaryOutcomes': [{'measure': 'Dimension of lesions identified at bp-MRI/mp-MRI;', 'timeFrame': '2 weeks', 'description': 'Mean lesion dimension will be assessed in each study arm'}, {'measure': 'The proportion of clinically significant PCa identified at bp-MRI;', 'timeFrame': '2 weeks', 'description': 'The number of clinically significant PCa over the total number of PCa detected at bp-MRI will be measured'}, {'measure': 'Positive predictive value of miR test alone and in combination with PSA blood test in identifying histologically confirmed PCa patients', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['magnetic resonance imaging', 'prostate biopsy', 'microRNA'], 'conditions': ['Prostatic Neoplasm']}, 'referencesModule': {'references': [{'pmid': '33893066', 'type': 'DERIVED', 'citation': 'Russo F, Mazzetti S, Regge D, Ambrosini I, Giannini V, Manfredi M, De Luca S, Bollito E, Porpiglia F. Diagnostic Accuracy of Single-plane Biparametric and Multiparametric Magnetic Resonance Imaging in Prostate Cancer: A Randomized Noninferiority Trial in Biopsy-naive Men. Eur Urol Oncol. 2021 Dec;4(6):855-862. doi: 10.1016/j.euo.2021.03.007. Epub 2021 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'To compare the detection rate of biparametric (bp) magnetic resonance imaging (MRI) for clinically significant prostate cancer (PCa) with that of multiparametric (mp)-MRI, in biopsy-naïve patients. Today, bp-MRI is not the standard diagnostic procedure, however preliminary studies showed its non-inferiority with respect to mp-MRI. Its implementation on a wide scale could significantly reduce examination costs (no iv contrast agent and no endorectal coil), and study time.\n\nSecondary objectives will be:\n\n* to assess specificity of a blood test based on microRNA (miR) score in biopsy-naïve patients, using pathological assessment after MR-guided biopsy as reference standard. If specificity of the miR score is higher than that of PSA, then fewer patients will undergo unnecessary MRI, thus increasing the efficiency of the diagnostic pipeline for PCa;\n* to develop a clinical decision support system (CDSS) based on MRI and circulating miR evaluation, to stratify patients according to their risk of PCa progression, using pathological assessment after prostatectomy as reference standard. Patients will be stratified into two classes of risk: i) low-risk PCa, in which patients may benefit from a conservative approach (i.e. active surveillance), and ii) medium/high-risk PCa in which patients should undergo radical treatment (i.e. surgery or radiation therapy).', 'detailedDescription': 'The trial is a prospective, randomized, two-arms study with a 2:1 ratio. Subjects meeting the inclusion criteria will be randomized either into the bp-MRI group (arm A), or the mp-MRI one (arm B). All subjects will perform blood sampling in EDTA tubes before undergoing imaging session. Plasma will be isolated within 1 hour from sampling, with a double round centrifugation, aliquoted and stored at -80°C before undergoing miR analysis.\n\nMRI will be performed with a 1.5 T using axial T2w and diffusion-weighted imaging for subjects in arm A with no endorectal coil and no intravenous contrast agent. Men randomized in arm B will undergo MRI with T2w in the three acquisition planes, diffusion-weighted and dynamic contrast-enhanced imaging usign endorectal coil.\n\nRandom biopsy will be performed in subjects with no suspicious regions for PCa found on MRI. Men with suspicious regions on MRI will be invited to a targeted or in-bore biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\<= 75 years\n* PSA \\<= 15 ng/ml\n* no previous prostate biopsy\n* negative digital rectal examination\n* signed infomed conset\n\nExclusion Criteria:\n\n* known prostate cancer diagnosis\n* previous prostate biopsy or surgery\n* contraindication to MRI\n* non-cooperative subjects'}, 'identificationModule': {'nctId': 'NCT03693703', 'briefTitle': 'Comparison of Multi-parametric and Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': 'Cost-efficacy of a Preliminary Diagnostic Program Using Bi-parametric Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer and no Previous Prostate Biopsy: a Prospective Randomized Clinical Study Comparing Multiparametric and Bi-parametric Magnetic Resonance Imaging Results', 'orgStudyIdInfo': {'id': 'bpMRscr16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bi-parametric MRI', 'description': 'Patients will undergo axial T2-weighted and diffusion-weighted imaging (no contrast agent injection)', 'interventionNames': ['Diagnostic Test: bi-parametric MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'multi-parametric MRI', 'description': 'Patients will undergo multiparametric MRI including morphological study (T2- and T1-weighted imaging) and functional acquisitions (diffusion-weighted and dynamic contrast-enhanced imaging)', 'interventionNames': ['Diagnostic Test: multi-parametric MRI']}], 'interventions': [{'name': 'bi-parametric MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration', 'armGroupLabels': ['bi-parametric MRI']}, {'name': 'multi-parametric MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration', 'armGroupLabels': ['multi-parametric MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10060', 'city': 'Candiolo', 'state': 'Turin', 'country': 'Italy', 'facility': "Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}], 'overallOfficials': [{'name': 'Filippo Russo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione del Piemonte per l'Oncologia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}