Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:55 PM
Study NCT ID:
NCT05381103
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2022-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PSMA-PET to Guide Prostatectomy
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 288}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-15', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IIEF-EF sub scale score', 'timeFrame': '1 month', 'description': 'International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.'}, {'measure': 'IIEF-EF sub scale score', 'timeFrame': '3 months', 'description': 'International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.'}, {'measure': 'IIEF-EF sub scale score', 'timeFrame': '6 months', 'description': 'International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.'}, {'measure': 'IIEF-EF sub scale score', 'timeFrame': '12 months', 'description': 'International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.'}, {'measure': 'IIEF-EF sub scale score', 'timeFrame': '18 months', 'description': 'International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change in treatment plan', 'timeFrame': '1 month', 'description': 'Proportion of patients whose treatment plan would be changed by PSMA-PET. Treatment changes are defined as any change in surgical resection plan that affects one of 4 critical regions for quality of life'}, {'measure': 'Ratio of positive surgical margins to nerve bundles spared', 'timeFrame': '1 month'}, {'measure': 'EPE detection', 'timeFrame': '1 month', 'description': 'Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles'}, {'measure': 'Incontinence bother', 'timeFrame': '18 months', 'description': 'Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2'}, {'measure': 'Incontinence: using 0-1 pads per day', 'timeFrame': '18 months', 'description': 'Expanded Prostate Cancer Index Composite (EPIC-26) question 3'}, {'measure': 'Urgency/frequency', 'timeFrame': '18 months', 'description': 'Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5'}, {'measure': 'Erectile dysfunction: ability to achieve erection sufficient for penetration', 'timeFrame': '18 months', 'description': 'IIEF question 3'}, {'measure': 'Overall mental and physical health', 'timeFrame': '18 months', 'description': 'Short Form quality of life questionnaire (SF-36)'}, {'measure': 'Surgical margins', 'timeFrame': '1 month', 'description': 'postive surgical margin rates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Significant prostate cancer:\n\n Gleason 3+4 ≥1 core with pattern 4 ≥20%\n\n Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR\n\n NCCN unfavorable intermediate risk OR\n\n Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND\n2. Baseline sexual function (IIEF-EF \\> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND\n3. The patient desires to maintain erections following treatment\n4. Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.\n5. Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.\n\nExclusion Criteria:\n\n1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.\n2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).\n3. 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': 'NCT05381103', 'briefTitle': 'PSMA-PET to Guide Prostatectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Five Eleven Pharma, Inc.'}, 'officialTitle': 'PSMA-PET to Guide Prostatectomy: A Randomized Trial', 'orgStudyIdInfo': {'id': 'IU_CLN02_EPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PSMA-PET and SOC MRI prior to surgery', 'interventionNames': ['Diagnostic Test: PSMA-PET and SOC MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOC MRI prior to surgery', 'interventionNames': ['Diagnostic Test: SOC MRI']}], 'interventions': [{'name': 'PSMA-PET and SOC MRI', 'type': 'DIAGNOSTIC_TEST', 'description': '60 min continuous acquisition of PET data after 3-6 mCI injection of \\[68Ga\\]P16-093 followed by contrast-CT', 'armGroupLabels': ['PSMA-PET and SOC MRI prior to surgery']}, {'name': 'SOC MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard of care MRI', 'armGroupLabels': ['SOC MRI prior to surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Green, Ph.D', 'role': 'CONTACT'}], 'facility': 'Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Jennifer Lehman', 'role': 'CONTACT', 'email': 'jgeck@iu.edu', 'phone': '317-274-1791'}], 'overallOfficials': [{'name': 'Clinton Bahler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Five Eleven Pharma, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Indiana University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}