Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-10 @ 2:29 PM
Study NCT ID:
NCT03264456
Status:
COMPLETED
Last Update Posted:
2020-03-09
First Post:
2017-08-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117460', 'term': 'fluciclovine F-18'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'samuelgalgano@uabmc.edu', 'phone': '2059341388', 'title': 'Samuel Galgano', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 8 week follow-up scan', 'description': 'Given that fluciclovine is a FDA clinically approved radiotracer with almost no risk of serious adverse events and all cause mortality, the expected risk of these in this study is effectively 0.', 'eventGroups': [{'id': 'EG000', 'title': '[18F] Fluciclovine PET/MRI', 'description': '\\[18F\\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer\n\n\\[18F\\] Fluciclovine PET/MRI: \\[18F\\] fluciclovine PET/MRI\n\n\\[18F\\] fluciclovine: \\[18F\\] fluciclovine', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Primary Lesions Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[18F] Fluciclovine PET/MRI', 'description': '\\[18F\\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer\n\n\\[18F\\] Fluciclovine PET/MRI: \\[18F\\] fluciclovine PET/MRI\n\n\\[18F\\] fluciclovine: \\[18F\\] fluciclovine'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 24 hr', 'description': 'Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[18F] Fluciclovine PET/MRI', 'description': '\\[18F\\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer\n\n\\[18F\\] Fluciclovine PET/MRI: \\[18F\\] fluciclovine PET/MRI\n\n\\[18F\\] fluciclovine: \\[18F\\] fluciclovine'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 24 hours', 'description': 'Number of patients with nodal metastases detected on \\[18F\\]fluciclovine PET/MRI', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[18F] Fluciclovine PET/MRI', 'description': '\\[18F\\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer\n\n\\[18F\\] Fluciclovine PET/MRI: \\[18F\\] fluciclovine PET/MRI\n\n\\[18F\\] fluciclovine: \\[18F\\] fluciclovine'}], 'classes': [{'title': 'MR alone', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'PET/MRI', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through 24 hours', 'description': 'Compare number of patients with nodal metastases detected on \\[18F\\]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of patients who demonstrated nodal metastatic disease on fluciclovine-PET/MRI'}, {'type': 'SECONDARY', 'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[18F] Fluciclovine PET/MRI', 'description': '\\[18F\\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer\n\n\\[18F\\] Fluciclovine PET/MRI: \\[18F\\] fluciclovine PET/MRI\n\n\\[18F\\] fluciclovine: \\[18F\\] fluciclovine'}], 'classes': [{'title': 'Pretreatment maximum SUV', 'categories': [{'measurements': [{'value': '7.1', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Maximum SUV after 8 weeks of ADT', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through 8 weeks', 'description': 'Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)', 'unitOfMeasure': 'standardized uptake values', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients in total cohort who underwent ADT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '[18F] Fluciclovine PET/MRI', 'description': '\\[18F\\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer\n\n\\[18F\\] Fluciclovine PET/MRI: \\[18F\\] fluciclovine PET/MRI\n\n\\[18F\\] fluciclovine: \\[18F\\] fluciclovine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': "Three consented patients chose not to undergo the initial PET/MRI scan prior to the scan being performed. Additionally, one patient's images were lost to data corruption and the patient was not included in the final analysis."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '[18F] Fluciclovine PET/MRI', 'description': '\\[18F\\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer\n\n\\[18F\\] Fluciclovine PET/MRI: \\[18F\\] fluciclovine PET/MRI\n\n\\[18F\\] fluciclovine: \\[18F\\] fluciclovine'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', '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': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-11', 'size': 801393, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-10T14:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-26', 'studyFirstSubmitDate': '2017-08-22', 'resultsFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2017-08-24', 'lastUpdatePostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-10', 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Primary Lesions Detected', 'timeFrame': 'Baseline through 24 hr', 'description': 'Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI'}, {'measure': 'Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI', 'timeFrame': 'Baseline through 24 hours', 'description': 'Number of patients with nodal metastases detected on \\[18F\\]fluciclovine PET/MRI'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI', 'timeFrame': 'Baseline through 24 hours', 'description': 'Compare number of patients with nodal metastases detected on \\[18F\\]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.'}, {'measure': 'Follow-up', 'timeFrame': 'Baseline through 8 weeks', 'description': 'Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '33052718', 'type': 'DERIVED', 'citation': 'Galgano SJ, McDonald AM, Rais-Bahrami S, Porter KK, Choudhary G, Burgan C, Bhambhvani P, Nix JW, Morgan DE, Li Y, Thomas JV, McConathy J. Utility of 18F-Fluciclovine PET/MRI for Staging Newly Diagnosed High-Risk Prostate Cancer and Evaluating Response to Initial Androgen Deprivation Therapy: A Prospective Single-Arm Pilot Study. AJR Am J Roentgenol. 2021 Sep;217(3):720-729. doi: 10.2214/AJR.20.24509. Epub 2020 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'There is great need for improved preoperative imaging in men with high-risk prostate cancer. Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently problematic. Conventional imaging is falsely negative for regional lymph node metastases in a substantial fraction of men. In particular, approximately 35% of men with high-risk prostate cancer will have biochemical recurrence even after optimal surgical resection. A major benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18 fluciclovine PET includes having the patient undergo a single imaging study which provides both anatomic and molecular characterization of the tumor, including metastases which would potentially be missed by conventional anatomic imaging and size criteria. Additionally, simultaneous acquisition will improve co-registration of the PET and MR data which is valuable for small lesions and in anatomically complex regions. Although the use of fluciclovine in the characterization of the primary PCa remains to be established, the anatomic detail provided by conventional mpMRI will complement the detection of small volume metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology allows for the assessment of dynamic tracer uptake and washout during the whole body and regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology to develop new treatment algorithms for the optimal management of these patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or serum PSA \\> 20)\n\nExclusion Criteria:\n\n* Inability to tolerate or undergo PET/MRI\n* Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)\n* Recurrent prostate adenocarcinoma\n* Known visceral, osseous, or extrapelvic metastases prior to fluciclovine-PET/MRI\n* Known allergy to glucagon or gadolinium-based contrast"}, 'identificationModule': {'nctId': 'NCT03264456', 'briefTitle': 'Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Pretreatment Staging of High-Risk Prostate Cancer With 18F-Fluciclovine PET/MRI', 'orgStudyIdInfo': {'id': 'IRB-300000291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F] Fluciclovine PET/MRI', 'description': '\\[18F\\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer', 'interventionNames': ['Diagnostic Test: [18F] Fluciclovine PET/MRI', 'Drug: [18F] fluciclovine']}], 'interventions': [{'name': '[18F] Fluciclovine PET/MRI', 'type': 'DIAGNOSTIC_TEST', 'description': '\\[18F\\] fluciclovine PET/MRI', 'armGroupLabels': ['[18F] Fluciclovine PET/MRI']}, {'name': '[18F] fluciclovine', 'type': 'DRUG', 'description': '\\[18F\\] fluciclovine', 'armGroupLabels': ['[18F] Fluciclovine PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Samuel Galgano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Samuel Joseph Galgano', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}