Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-01 @ 12:39 AM
Study NCT ID:
NCT04936334
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2021-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}}}}, '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': 'jgeck@iu.edu', 'phone': '317-948-9575', 'title': 'Jennifer Lehman, RN, Senior Research Leader', 'organization': 'Indiana University, Department of Urology'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day, the day of imaging.', 'description': 'Patient were monitored during injection of the (Ga68)PSMA-11 and afterwards for at least 60minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'PSMA-PET and MRI in Men Scheduled for Prostatectomy', 'description': 'Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI.\n\nThere were 100 prostate lobes examined with 2 lobes per patient.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'prostate lobes', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PSMA-PET in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy', 'description': 'Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery\n\nThere were 100 prostate lobes examined with 2 lobes per patient.'}, {'id': 'OG001', 'title': 'MRI in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy', 'description': 'Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo imaging with MRI in addition to PSMA-PET.\n\nThere were 100 prostate lobes examined with 2 lobes per patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '100'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '78'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'McNemar', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.03', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.', 'description': 'Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'prostate lobes', 'denomUnitsSelected': 'prostate lobes', 'populationDescription': 'Men diagnosed with prostate cancer often seek surgical treatment. Surgical treatment--radical prostatectomy--is currently guided by clinical parameters (PSA, pathology) and MRI imaging. These men often have considerable concerns about the balance of cancer control and quality of life after the surgery. There were 100 prostate lobes examined with 2 lobes per patient. One patient was enrolled but did not complete study procedures.'}, {'type': 'PRIMARY', 'title': 'Specificity of PSMA-PET and MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'units': 'prostate lobes', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PSMA-PET in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy', 'description': 'Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery\n\nThere were 100 prostate lobes examined with 2 lobes per patient.'}, {'id': 'OG001', 'title': 'MRI in Men Diagnosed With Clinically Significant Prostate Cancer Scheduled for Prostatectomy', 'description': 'Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo imaging with MRI in addition to PSMA-PET.\n\nThere were 100 prostate lobes examined with 2 lobes per patient.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '83'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '86'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-surgery prediction.', 'description': 'Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'prostate lobes', 'denomUnitsSelected': 'prostate lobes'}, {'type': 'SECONDARY', 'title': '1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PSMA-PET and MRI in Men Scheduled for Prostatectomy', 'description': 'Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 Days', 'description': 'Rate of treatment changes', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PSMA-PET and MRI in Men Scheduled for Prostatectomy', 'description': 'Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI.\n\nThere were 100 prostate lobes examined with 2 lobes per patient.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '102', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '100', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Metastatic disease found on PSMA-PET, surgery cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Prostate lobes (right and left)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PSMA-PET and MRI in Men Scheduled for Prostatectomy', 'description': 'Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo PSMA PET and MRI.\n\nThere were 100 prostate lobes examined with 2 lobes per patient.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', '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': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PSA', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'BG000', 'lowerLimit': '5.5', 'upperLimit': '8.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gleason Grade-group, final pathology', 'classes': [{'title': 'Grade-Group 1 (Gleason)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Grade-Group 2 (Gleason)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Grade-Group 3 (Gleason)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Grade-Group 4 (Gleason)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Grade-Group 5', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'This is pathology. Prostate cancer uses Gleason grading system, which is organized as the Grade group as follows:\n\n3+3 = 1, 3+4 = 2, 4+3 = 3, 4+4 = 4, 4+5 = 5,\n\nGrade group 1 indicates a lower grade cancer.', 'unitOfMeasure': 'participants'}, {'title': 'Pathologic stage (T)', 'classes': [{'title': 'pT2', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': 'pT3a', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'pT3b', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'pT4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'T-stage:\n\npT2 (organ confined), pT3a (extra-prostate extension), pT3b (Seminal vesicle invasion), pT4 (outside invasion)', 'unitOfMeasure': 'participants'}, {'title': 'Pathologic stage (N)', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This measure reports the total number of participants with positive lymph nodes. This is also referred to as pathologic N-stage. The N-stage indicates the number of total patients who had positive lymph nodes.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-29', 'size': 2709167, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-16T09:46', 'hasProtocol': True}, {'date': '2022-03-29', 'size': 161412, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-16T09:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2021-06-11', 'resultsFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2021-06-19', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-26', 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension', 'timeFrame': 'The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.', 'description': 'Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles'}, {'measure': 'Specificity of PSMA-PET and MRI', 'timeFrame': 'Pre-surgery prediction.', 'description': 'Specificity of PSMA-PET and MRI to detect Extra-prostatic extension prior to prostatectomy. Whole mount pathology is used as the reference standard.'}], 'secondaryOutcomes': [{'measure': '1) Quantify the Frequency of Proper Treatment Changes for Nerve Sparing Directed by PSMA-PET', 'timeFrame': '60 Days', 'description': 'Rate of treatment changes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '38785259', 'type': 'DERIVED', 'citation': 'Bahler CD, Tachibana I, Tann M, Collins K, Swensson JK, Green MA, Mathias CJ, Tong Y, Yong C, Boris RS, Brocken E, Hutchins GD, Sims JB, Hill DV, Smith N, Ferari C, Love H, Koch MO. Comparing Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen-Positron Emission Tomography for Prediction of Extraprostatic Extension of Prostate Cancer and Surgical Guidance: A Prospective Nonrandomized Clinical Trial. J Urol. 2024 Aug;212(2):290-298. doi: 10.1097/JU.0000000000004032. Epub 2024 May 24.'}]}, 'descriptionModule': {'briefSummary': 'Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).\n\nQuantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).\n\nDirectly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.\n\nAssess quality of life changes from preoperative baseline.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:\n\n 1. \\> 3 cores of Gleason 3+4 or\n 2. NCCN unfavorable intermediate risk or\n 3. NCCN high-risk or\n 4. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).\n\nWilling and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI\n\nExclusion Criteria:\n\n* 1\\. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.\n\n 2\\. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).\n\n 3\\. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.'}, 'identificationModule': {'nctId': 'NCT04936334', 'briefTitle': 'The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial', 'orgStudyIdInfo': {'id': 'IUSCCC-0760'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy', 'description': '1\\. Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery', 'interventionNames': ['Diagnostic Test: 68Ga-PSMA-11 PET Scan']}], 'interventions': [{'name': '68Ga-PSMA-11 PET Scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.', 'armGroupLabels': ['Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinton Bahler', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Clinton Bahler', 'investigatorAffiliation': 'Indiana University'}}}}