Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-07 @ 12:06 PM
Study NCT ID:
NCT02918357
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
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': 'C000718244', 'term': 'gallium 68 PSMA-11'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.hope@ucsf.edu', 'phone': '(415) 221-4810', 'title': 'Dr. Thomas Hope', 'phoneExt': '2264', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Patients were monitored for adverse events during and for 2 hours after radiotracer administration. Patients were also contacted by phone to assess for the development of delayed adverse events up to 24 hours after radiotracer administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Ga-68 Labeled PSMA-11 PET', 'description': 'PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.\n\nGa-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.', 'otherNumAtRisk': 385, 'deathsNumAtRisk': 385, 'otherNumAffected': 0, 'seriousNumAtRisk': 385, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pet Positive (Per Patient)', 'description': 'Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '0.94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.', 'unitOfMeasure': 'percentage of times value is true', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per patient basis. Per patient analyses included an evaluation of positive or negative for presence of localized prostate cancer (PCa).'}, {'type': 'PRIMARY', 'title': 'Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pet Positive (Per Region)', 'description': 'Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '0.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.', 'unitOfMeasure': 'percentage of times value is true', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per region basis. Per region analyses included an evaluation of positive or negative for presence of PCa. Regional analyses included prostate bed, pelvic nodes, extrapelvic non-bone, and bone.'}, {'type': 'SECONDARY', 'title': 'PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pet Positive (Per Patient)', 'description': 'Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.89'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.', 'unitOfMeasure': 'percentage of times value is true', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One hundred and twenty-five patients had confirmed imaging at follow-up for this analysis'}, {'type': 'SECONDARY', 'title': 'PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pet Positive (Per Patient)', 'description': 'Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '0.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.', 'unitOfMeasure': 'percentage of times value is true', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Two-hundred and forty-nine patients had confirmed regional imaging in follow up for this sample.'}, {'type': 'SECONDARY', 'title': 'Sensitivity on a Per-patient Basis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ga-68 Labeled PSMA-11 PET', 'description': 'PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.\n\nGa-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.84', 'upperLimit': '0.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.', 'unitOfMeasure': 'percentage of sensitivity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventy-nine patients had confirmed patient histopathology validation for this analysis'}, {'type': 'SECONDARY', 'title': 'Sensitivity on a Per-region Basis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ga-68 Labeled PSMA-11 PET', 'description': 'PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.\n\nGa-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '0.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.', 'unitOfMeasure': 'percentage of sensitivity', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eighty-four patients had confirmed histopathology region validation for this analysis'}, {'type': 'SECONDARY', 'title': 'Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PSA <0.5', 'description': 'Patients whom have a PSA nadir value of \\<0.5'}, {'id': 'OG001', 'title': 'PSA 0.5 - <1.0', 'description': 'Patients whom have a PSA nadir value of 0.5 to \\<1.0'}, {'id': 'OG002', 'title': 'PSA 1.0 - <2.0', 'description': 'Patients whom have a PSA nadir value of 1.0 to \\<2.0'}, {'id': 'OG003', 'title': 'PSA 2.0 - <5.0', 'description': 'Patients whom have a PSA nadir value of 2.0 - \\<5.0'}, {'id': 'OG004', 'title': 'PSA ≥5.0', 'description': 'Patients whom have a PSA nadir value of ≥5.0'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}, {'value': '96', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-\\<0.5; 0.5-\\<1.0; 1.0-\\<2.0; 2.0-\\<5.0, and ≥5.0).', 'unitOfMeasure': 'percentage detected', 'reportingStatus': 'POSTED', 'populationDescription': 'Portion of patients with 68Ga-PSMA-11 PET positive findings were stratified by PSA range and disease location in accordance with Prostate Magnetic Resonance Imaging Study (PROMIS)'}, {'type': 'SECONDARY', 'title': 'Inter-reader Agreement Per-region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Prostate Bed', 'description': 'Patients who have the prostate bed included in their study scan'}, {'id': 'OG001', 'title': 'Pelvic Nodes', 'description': 'Patients who have the pelvic nodes included in their study scan'}, {'id': 'OG002', 'title': 'Extrapelvic Soft Tissue', 'description': 'Patients who have the extrapelvic soft tissue included in their study scan'}, {'id': 'OG003', 'title': 'Bone', 'description': 'Patients who have the pelvic bone included in their study scan'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '0.70'}, {'value': '0.73', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '0.78'}, {'value': '0.70', 'groupId': 'OG002', 'lowerLimit': '0.65', 'upperLimit': '0.74'}, {'value': '0.78', 'groupId': 'OG003', 'lowerLimit': '0.73', 'upperLimit': '0.82'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': "Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).", 'unitOfMeasure': 'kappa', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included in the analyses were scanned to include all regions under review'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in Clinical Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ga-68 Labeled PSMA-11 PET', 'description': 'Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year', 'description': 'Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety Assessment - Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-Infusion Heart Rate', 'description': 'All patients were assessed for safety measures that included Heart Rate before infusion'}, {'id': 'OG001', 'title': 'Post-Infusion Heart Rate', 'description': 'All patients were assessed for safety measures that included Heart Rate after infusion'}, {'id': 'OG002', 'title': 'Absolute Change in Heart Rate', 'description': 'All subjects had the absolute mean in heart rate calculated to assess for safety'}], 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '66.9', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '11.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety Assessment - Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-Injection', 'description': 'All patients were assessed for safety measures that included blood pressure before infusion'}, {'id': 'OG001', 'title': 'Post-Injection', 'description': 'All patients were assessed for safety measures that included blood pressure after infusion'}, {'id': 'OG002', 'title': 'Absolute Mean Change', 'description': 'All subjects had the absolute mean in blood pressure calculated to assess for safety'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '137.8', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '137.0', 'spread': '17.4', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '18.6', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '80.3', 'spread': '33.8', 'groupId': 'OG000'}, {'value': '81.1', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '34.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pressure exerted by a 1 millimeter vertical column of mercury (Hg) at 0 degree Celsius is defined as (mmHg)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ga-68 Labeled PSMA-11 Positron Emission Tomography (PET)', 'description': 'Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.\n\nGa-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}]}, {'type': 'Investigational Drug Administration', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}]}, {'type': 'PET/CT Scan', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '385'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ga-68 Labeled PSMA-11 PET', 'description': 'PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.\n\nGa-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '95'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '385', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '318', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Native American and Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '385', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Initial therapy', 'classes': [{'categories': [{'title': 'Prostatectomy only', 'measurements': [{'value': '132', 'groupId': 'BG000'}]}, {'title': 'Radiotherapy only', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}, {'title': 'Prostatectomy and Salvage Radiotherapy', 'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-21', 'size': 787134, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-30T19:52', 'hasProtocol': True}, {'date': '2017-10-18', 'size': 429152, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-10-23T15:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 385}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-27', 'studyFirstSubmitDate': '2016-09-27', 'resultsFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-27', 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation', 'timeFrame': '1 month', 'description': 'PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.'}, {'measure': 'Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation', 'timeFrame': '1 month', 'description': 'PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.'}], 'secondaryOutcomes': [{'measure': 'PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up', 'timeFrame': '1 month', 'description': 'PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.'}, {'measure': 'PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up', 'timeFrame': '1 month', 'description': 'PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.'}, {'measure': 'Sensitivity on a Per-patient Basis', 'timeFrame': '1 month', 'description': 'Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.'}, {'measure': 'Sensitivity on a Per-region Basis', 'timeFrame': '1 month', 'description': 'Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.'}, {'measure': 'Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value', 'timeFrame': '1 month', 'description': 'Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-\\<0.5; 0.5-\\<1.0; 1.0-\\<2.0; 2.0-\\<5.0, and ≥5.0).'}, {'measure': 'Inter-reader Agreement Per-region', 'timeFrame': '1 month', 'description': "Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement)."}, {'measure': 'Percentage of Participants With Change in Clinical Management', 'timeFrame': 'Up to 1 year', 'description': 'Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.'}, {'measure': 'Safety Assessment - Heart Rate', 'timeFrame': '1 day', 'description': 'Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.'}, {'measure': 'Safety Assessment - Blood Pressure', 'timeFrame': '1 day', 'description': 'Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.", 'detailedDescription': 'Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathological proven prostate adenocarcinoma.\n* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).\n\n * Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation\n\n * PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,\n * Confirmatory persistent PSA greater than 0.2 ng/mL\n * Post-radiation therapy -ASTRO-Phoenix consensus definition\n\n * Nadir + greater than or equal to 2 ng/mL rise in PSA\n* Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).\n* Age \\> 18.\n* Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\n* Investigational therapy for prostate cancer.\n* Unable to lie flat, still or tolerate a PET scan.\n* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.\n* Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).'}, 'identificationModule': {'nctId': 'NCT02918357', 'acronym': 'PSMA BCR', 'briefTitle': 'Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence', 'orgStudyIdInfo': {'id': '165510'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00039', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ga-68 labeled PSMA-11 PET', 'description': 'PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.', 'interventionNames': ['Drug: Ga-68 labeled PSMA-11 PET']}], 'interventions': [{'name': 'Ga-68 labeled PSMA-11 PET', 'type': 'DRUG', 'otherNames': ['Ga-68 labeled DKFZ-PSMA-11', 'Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC', 'Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC', 'Ga-68 labeled HBED-CC PSMA'], 'description': 'Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.', 'armGroupLabels': ['Ga-68 labeled PSMA-11 PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Thomas Hope, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Radiology and Biomedical Imaging', 'investigatorFullName': 'Thomas Hope', 'investigatorAffiliation': 'University of California, San Francisco'}}}}