Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT03585660
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2018-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
Sponsor:
Organization:
Raw JSON
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The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 0, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of HM-MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.\n\nDiagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.\n\nDiagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.45', 'upperLimit': '0.65'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000'], 'groupDescription': 'The null hypothesis is that the accuracy of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the accuracy of HM-MRI is greater than the accuracy of mp-MRI.', 'statisticalMethod': 'bootstrap z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The standard error of the difference in accuracy was estimated using nonparametric bootstrap, with B=9999 resamples.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the ROC Curve (AUC) of HM-MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.\n\nDiagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.\n\nDiagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '0.52', 'upperLimit': '0.74'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000'], 'groupDescription': 'The null hypothesis is that the AUCs of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the AUC of HM-MRI is greater than the AUC of mp-MRI.', 'statisticalMethod': 'bootstrap z-test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The standard error of the difference of AUCs was estimated using nonparametric bootstrap, with B=9999 resamples.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1.', 'unitOfMeasure': 'probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sensitivity of HM-MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.\n\nDiagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.\n\nDiagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '1'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000'], 'groupDescription': 'The null hypothesis is that the sensitivity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the sensitivity of HM-MRI is greater than the sensitivity of mp-MRI.', 'statisticalMethod': 'bootstrap z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Sensitivity of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using HM-MRI among the participants who were found positive of prostate cancer using biopsy.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Specificity of HM-MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.\n\nDiagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.\n\nDiagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.48'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'groupDescription': 'The null hypothesis is that the specificity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the specificity of HM-MRI is greater than the specificity of mp-MRI.', 'statisticalMethod': 'bootstrap z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Specificity of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using HM-MRI among the participants who were found negative using biopsy.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Positive Predictive Value (PPV) of HM-MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.\n\nDiagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.\n\nDiagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '0.55'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000'], 'statisticalMethod': 'bootstrap z-test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the PPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the PPV of HM-MRI is greater than the PPV of mp-MRI.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Positive predictive value (PPV) of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using biopsy among the participants who were found positive using HM-MRI.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Negative Predictive Value (NPV) of HM-MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.\n\nDiagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.\n\nDiagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '1'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000'], 'statisticalMethod': 'bootstrap z-test', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the NPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the NPV of HM-MRI is greater than the NPV of mp-MRI.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Negative predictive value (NPV) of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using biopsy among the participants who were found negative using HM-MRI.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.\n\nDiagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.\n\nDiagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'operator error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'technical error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'hip prosthesis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'did not undergo biopsy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'scanner problem', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '106 patients were enrolled in the study. Patients were recruited based on physician referral at UChicago Medical Center. The 1st patient was enrolled on August 28, 2018, and the last patient was enrolled on March 29, 2023.', 'preAssignmentDetails': '112 patients were screened and 6 patients did not meet eligibility criteria of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.\n\nDiagnostic MRI: Participants will be scanned using a standard clinical prostate MRI protocol.\n\nDiagnostic Prostate Biopsy: Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.\n\nRisk Map DSS tool: The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.44', 'spread': '7.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prostate Specific Antigen (PSA)', 'classes': [{'categories': [{'measurements': [{'value': '8.81', 'spread': '11.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-10', 'size': 1191925, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-08T10:58', 'hasProtocol': True}, {'date': '2024-03-28', 'size': 418395, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-05-08T10:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2018-06-19', 'resultsFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-04', 'studyFirstPostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of HM-MRI', 'timeFrame': '12 months', 'description': 'The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.'}, {'measure': 'Area Under the ROC Curve (AUC) of HM-MRI', 'timeFrame': '12 months', 'description': 'In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of HM-MRI', 'timeFrame': '12 months', 'description': 'Sensitivity of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using HM-MRI among the participants who were found positive of prostate cancer using biopsy.'}, {'measure': 'Specificity of HM-MRI', 'timeFrame': '12 months', 'description': 'Specificity of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using HM-MRI among the participants who were found negative using biopsy.'}, {'measure': 'Positive Predictive Value (PPV) of HM-MRI', 'timeFrame': '12 months', 'description': 'Positive predictive value (PPV) of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using biopsy among the participants who were found positive using HM-MRI.'}, {'measure': 'Negative Predictive Value (NPV) of HM-MRI', 'timeFrame': '12 months', 'description': 'Negative predictive value (NPV) of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using biopsy among the participants who were found negative using HM-MRI.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '39836080', 'type': 'DERIVED', 'citation': 'Chatterjee A, Yousuf AN, Engelmann R, Harmath C, Lee G, Medved M, Jamison EB, Lorente Campos A, Gundogdu B, Gerber G, Reynolds LF, Modi PK, Antic T, Giurcanu M, Eggener S, Karczmar GS, Oto A. Prospective Validation of an Automated Hybrid Multidimensional MRI Tool for Prostate Cancer Detection Using Targeted Biopsy: Comparison with PI-RADS-based Assessment. Radiol Imaging Cancer. 2025 Jan;7(1):e240156. doi: 10.1148/rycan.240156.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Patients incapable of giving informed written consent;\n* Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;\n* Patients with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.\n* Prisoners;\n* Minor children (under the age of 18 years old).'}, 'identificationModule': {'nctId': 'NCT03585660', 'briefTitle': 'Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy', 'orgStudyIdInfo': {'id': 'IRB17-1694'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Arm', 'description': 'Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.', 'interventionNames': ['Procedure: Diagnostic MRI', 'Procedure: Diagnostic Prostate Biopsy', 'Device: Risk Map DSS tool']}], 'interventions': [{'name': 'Diagnostic MRI', 'type': 'PROCEDURE', 'description': 'Participants will be scanned using a standard clinical prostate MRI protocol.', 'armGroupLabels': ['Interventional Arm']}, {'name': 'Diagnostic Prostate Biopsy', 'type': 'PROCEDURE', 'description': 'Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.', 'armGroupLabels': ['Interventional Arm']}, {'name': 'Risk Map DSS tool', 'type': 'DEVICE', 'description': 'The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.', 'armGroupLabels': ['Interventional Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Aytekin Oto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}