Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT03459820
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-27
First Post:
2018-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prostate Cancer Patient Management With 18F-DCFPyL PET/CT
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2018-03-03', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in optimal clinical management', 'timeFrame': '30 days', 'description': 'Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.'}], 'secondaryOutcomes': [{'measure': 'Scan positivity fraction in BCR by PSA.', 'timeFrame': '30 days', 'description': '18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.'}, {'measure': 'Adverse events', 'timeFrame': '2 hours', 'description': 'Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.', 'detailedDescription': 'Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts.\n\nPrimary endpoint:\n\n1\\. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.\n\nSecondary endpoints:\n\n1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.\n2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only patients with prostate cancer are included.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male sex\n* Age 18 years or older\n* Previously diagnosed with prostate cancer, under referring physician's care\n* ECOG performance status 0 - 3, inclusive\n* Able to understand and provide written informed consent\n* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection\n\nCohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following:\n\n* Gleason score \\> 7\n* Serum PSA \\> 15 ng/ml\n* T stage of T3 or greater on TNM staging\n* Equivocal/inconclusive conventional staging such as CT, MRI or bone scan\n* Clinical suspicion of advance stage disease (e.g. bone pain)\n\nCohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.\n\nExclusion Criteria:\n\n* Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)\n* Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)\n* Patients with unmanageable claustrophobia"}, 'identificationModule': {'nctId': 'NCT03459820', 'briefTitle': 'Prostate Cancer Patient Management With 18F-DCFPyL PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'Sir Mortimer B. Davis - Jewish General Hospital'}, 'officialTitle': 'Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT', 'orgStudyIdInfo': {'id': '18-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-DCFPyL PET/CT', 'description': '18F-DCFPyL PET/CT Scan', 'interventionNames': ['Diagnostic Test: 18F-DCFPyL PET/CT']}], 'interventions': [{'name': '18F-DCFPyL PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': '18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan', 'armGroupLabels': ['18F-DCFPyL PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Mortimer B. Davis - Jewish General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Nuclear Medicine', 'investigatorFullName': 'Stephan Probst, MD', 'investigatorAffiliation': 'Sir Mortimer B. Davis - Jewish General Hospital'}}}}