Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT03366792
Status:
TERMINATED
Last Update Posted:
2022-03-23
First Post:
2017-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Samir.Taneja@nyulangone.org', 'phone': '(212) 263-6301', 'title': 'Samir S. Taneja, MD', 'organization': 'NYU Langone Health - Perlmutter Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 months', 'eventGroups': [{'id': 'EG000', 'title': 'MRI Targeted Biopsy', 'description': 'Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 2, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Core Cancer Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MRI Targeted Biopsy', 'description': 'Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.'}], 'classes': [{'title': 'TP', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1.875', 'upperLimit': '6.75'}]}]}, {'title': 'TR', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '7.75'}]}]}, {'title': 'TP+TR', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1.95', 'upperLimit': '7.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 Months', 'description': 'Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of High-Grade Prostate Cancer Using Gleason Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MRI Targeted Biopsy', 'description': 'Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.'}], 'classes': [{'title': 'TP', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'TR', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'TP+TR', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 Months', 'description': 'High-grade prostate cancer is defined as a Gleason score \\> 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor.\n\nData is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR)', 'unitOfMeasure': 'percentage of prostate cancer grades', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MRI Targeted Biopsy', 'description': 'Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Ineligible (could not reach perinium)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Study Closure (interim analysis showed no significant results)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MRI Targeted Biopsy', 'description': 'Artemis™ software system: Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-05', 'size': 316331, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-02-24T18:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'Investigators chose to discontinue the study based on interim findings', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2017-11-21', 'resultsFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-24', 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Cancer Length', 'timeFrame': '2 Months', 'description': 'Greater tumor length per core provides better diagnostic information. Data is reported as Transperineal (TP) core cancer length, Transrectal (TR) core cancer length, and for both (TP+TR)'}], 'secondaryOutcomes': [{'measure': 'Percentage of High-Grade Prostate Cancer Using Gleason Score', 'timeFrame': '2 Months', 'description': 'High-grade prostate cancer is defined as a Gleason score \\> 6; a score that is the sum of the two Gleason grades assigned to a prostate tumor and that is based on a scale of 2 to 10 with the lowest numbers indicating a slow-growing tumor unlikely to spread and the highest numbers indicating an aggressive tumor.\n\nData is reported as a percentage for Transperineal (TP), Transrectal (TR), and for both (TP+TR)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate a transperineal biopsy approach (outside of the rectum) using MRI targeting to facilitate better access to the whole prostate gland and provide limited risk of infectious complications after biopsy.', 'detailedDescription': 'Prostate cancer is the most common malignancy and the second most common cause of cancer death in men in the Western hemisphere. Definitive diagnosis of prostate cancer relies on biopsy of the prostate gland, which is historically performed by taking 12 random biopsies of the prostate by placing a needle through the rectum under ultrasound guidance. Recently, advances in MRI techniques have allowed identification of suspicious lesions within the prostate prior to biopsy, which has given rise to targeting biopsy cores to high-suspicion areas using fused ultrasound-MRI images. However, the most commonly used transrectal approach to biopsy is associated with a growing rate of infectious complications as well as poor sampling of the anterior region of the prostate, which is furthest from the rectum.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations) Area of suspicion or known cancer focus on previously obtained mpMRI of the prostate (at least one lesion with MRI suspicion score \\>3/5)\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy\n* Evidence of urinary tract infection or significant urinary retention\n* Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI\n* No evidence of suspicious lesions on mpMRI\n* Irreversible coagulopathy\n* Contraindication to sedation'}, 'identificationModule': {'nctId': 'NCT03366792', 'briefTitle': 'Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Comparative Analysis of Transperineal Versus Transrectal Approaches for MRI-Targeted Biopsy of the Prostate for the Detection and Characterization of Prostate Cancer', 'orgStudyIdInfo': {'id': '14-01550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRI Targeted Biopsy', 'interventionNames': ['Device: Artemis™ software system']}], 'interventions': [{'name': 'Artemis™ software system', 'type': 'DEVICE', 'description': 'Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.', 'armGroupLabels': ['MRI Targeted Biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Samir Taneja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}