Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 5:32 AM
Study NCT ID:
NCT02981368
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572626', 'term': '2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.myl@lantheus.com', 'phone': '914-582-1120', 'title': 'David Myl', 'organization': 'Lantheus Medical Imaging / Progenics Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Study results cannot be published before the earlier of a multi-site publication; or 18 months after the end of the Study at all sites; or confirmation by Sponsor that there will be no multi-site publication. The proposed publication must be submitted to Sponsor at least 60 days prior to publication so that Sponsor can delete Sponsor Confidential Information (other than Study results) and obtain a further 60 days to file on any invention disclosed in the proposed publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy.', 'eventGroups': [{'id': 'EG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 26, 'seriousNumAtRisk': 268, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 1, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lower gastrointestinal haemmorhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'pyelonephritis, acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Central Reader 1', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000', 'lowerLimit': '94.52', 'upperLimit': '99.37'}]}]}, {'title': 'Central Reader 2', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96.00', 'upperLimit': '99.96'}]}]}, {'title': 'Central Reader 3', 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000', 'lowerLimit': '93.64', 'upperLimit': '98.99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.'}, {'type': 'PRIMARY', 'title': 'Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Central Reader 1', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000', 'lowerLimit': '29.65', 'upperLimit': '54.22'}]}]}, {'title': 'Central Reader 2', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '19.17', 'upperLimit': '42.12'}]}]}, {'title': 'Central Reader 3', 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000', 'lowerLimit': '28.11', 'upperLimit': '52.53'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.'}, {'type': 'SECONDARY', 'title': 'Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}, {'value': '117', 'groupId': 'OG003'}, {'value': '268', 'groupId': 'OG004'}, {'value': '117', 'groupId': 'OG005'}, {'value': '268', 'groupId': 'OG006'}, {'value': '117', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Follow-up Value: Low', 'description': 'Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.'}, {'id': 'OG001', 'title': 'Cohort B - Follow-up Value: Low', 'description': 'Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.'}, {'id': 'OG002', 'title': 'Cohort A - Follow-up Value: Normal', 'description': 'Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.'}, {'id': 'OG003', 'title': 'Cohort B - Follow-up Value Normal', 'description': 'Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.'}, {'id': 'OG004', 'title': 'Cohort A - Follow-up Value: High', 'description': 'Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.'}, {'id': 'OG005', 'title': 'Cohort B - Follow-up Value: High', 'description': 'Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.'}, {'id': 'OG006', 'title': 'Cohort A - Follow-up Value: Missing', 'description': 'Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.'}, {'id': 'OG007', 'title': 'Cohort B - Follow-up Value: Missing', 'description': 'Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.'}], 'classes': [{'title': 'Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Cohort A - Baseline Value: Low', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Normal', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Cohort A - Baseline Value: Low', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Cohort A - Baseline Value: Low', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Normal', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Cohort A - 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The Safety Set includes all participants who received any amount of 18F-DCFPyL. 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Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '73', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Cohort A - Baseline Value: Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - 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Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '36', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Cohort A - Baseline Value: Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Normal', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '75', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Cohort A - Baseline Value: Low', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Normal', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}, {'title': 'Cohort A - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Cohort B - Baseline Value: Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).', 'description': 'Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set includes all participants who received any amount of 18F-DCFPyL.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A) - Baseline ECG', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken on the day of dosing, prior to dosing.'}, {'id': 'OG001', 'title': 'High Risk Prostate Cancer (Cohort A) - Post-dosing ECG', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.'}, {'id': 'OG002', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}, {'id': 'OG003', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.'}], 'classes': [{'title': 'Normal ECG Evaluation', 'categories': [{'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Abnormal ECG Evaluation', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Changes in ECG pre-drug dosing and within 1-2 hours post-dosing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing ECG measurements).'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}, {'id': 'OG001', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Systolic Blood Pressure: Baseline (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '133.7', 'spread': '15.99', 'groupId': 'OG000'}, {'value': '133.6', 'spread': '19.00', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure: Post-dosing (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '133.7', 'spread': '16.57', 'groupId': 'OG000'}, {'value': '132.1', 'spread': '19.11', 'groupId': 'OG001'}]}]}, {'title': 'Systolic Blood Pressure: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '12.30', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '11.57', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure: Baseline (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.3', 'spread': '8.62', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '10.16', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure: Post-dosing (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.5', 'spread': '9.12', 'groupId': 'OG000'}, {'value': '76.4', 'spread': '9.02', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '7.04', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '8.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}, {'id': 'OG001', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Heart Rate: Baseline (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.7', 'spread': '12.03', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '12.94', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate: Post-dosing (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.4', 'spread': '10.98', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '11.23', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '6.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}, {'id': 'OG001', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Respiration Rate: Baseline (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Respiration Rate: Post-dosing (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '3.32', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'Respiration Rate: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.', 'unitOfMeasure': 'breaths per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}, {'id': 'OG001', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Temperature: Baseline (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.58', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '36.56', 'spread': '0.338', 'groupId': 'OG001'}]}]}, {'title': 'Temperature: Post-dosing (Actual)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.50', 'spread': '0.479', 'groupId': 'OG000'}, {'value': '36.59', 'spread': '0.309', 'groupId': 'OG001'}]}]}, {'title': 'Temperature: Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.496', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.265', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing vital sign measurements).'}, {'type': 'SECONDARY', 'title': 'Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Central Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '91.60', 'upperLimit': '100.00'}]}]}, {'title': 'Central Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '87.81', 'upperLimit': '99.04'}]}]}, {'title': 'Central Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '83.98', 'upperLimit': '97.28'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.', 'description': 'Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with recurrent or metastatic prostate cancer who received 18F-DCFPyL, underwent a conventional image-guided biopsy, and provided an 18F-DCFPyL PET/CT image result and a corresponding histopathology result, along with a conventional image that confirmed the location of the histopathology sample.'}, {'type': 'SECONDARY', 'title': 'Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A - Conventional Imaging', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.'}, {'id': 'OG001', 'title': 'Cohort A - 18F-DCFPyL PET/CT: Reader 1', 'description': 'One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.'}, {'id': 'OG002', 'title': 'Cohort A - 18F-DCFPyL PET/CT: Reader 2', 'description': 'One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.'}, {'id': 'OG003', 'title': 'Cohort A - 18F-DCFPyL PET/CT: Reader 3', 'description': 'One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.'}, {'id': 'OG004', 'title': 'Cohort B - Conventional Imaging', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) had baseline CT or MRI images provided to the independent central imaging core lab for assessment by a single reader for prostate cancer detection. The conventional central reader did not assess 18F-DCFPyL PET/CT images. The conventional imaging reader was blinded to local radiology assessments, clinical information, and 18F-DCFPyL PET/CT scans for study participants.'}, {'id': 'OG005', 'title': 'Cohort B - 18F-DCFPyL PET/CT: Reader 1', 'description': 'One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.'}, {'id': 'OG006', 'title': 'Cohort B - 18F-DCFPyL PET/CT: Reader 2', 'description': 'One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.'}, {'id': 'OG007', 'title': 'Cohort B - 18F-DCFPyL PET/CT: Reader 3', 'description': 'One of 3 independent core lab readers assigned to assess the 18F-DCFPyL PET/CT image for prostate cancer. The reader was blinded to local radiology assessments, clinical information, conventional imaging scans, and the 18F-DCFPyL PET/CT imaging reads performed by other independent core lab readers.'}], 'classes': [{'title': 'Tissue Site: Bone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Number of Lesions: 0', 'measurements': [{'value': '239', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '28', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 1-2', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 3-4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 5-6', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: >6', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}, {'value': '36', 'groupId': 'OG007'}]}]}, {'title': 'Tissue Site: Visceral/Soft Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Number of Lesions: 0', 'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '240', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}, {'value': '73', 'groupId': 'OG006'}, {'value': '64', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 1-2', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 3-4', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 5-6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: >6', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Tissue Site: Lymph Nodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Number of Lesions: 0', 'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '226', 'groupId': 'OG002'}, {'value': '218', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}, {'value': '38', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 1-2', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 3-4', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 5-6', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: >6', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}]}]}, {'title': 'Tissue Site: Prostate Gland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}, {'value': '91', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Number of Lesions: 0', 'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '79', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}, {'value': '69', 'groupId': 'OG006'}, {'value': '63', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 1-2', 'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '204', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 3-4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 5-6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: >6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Tissue Site: All', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '252', 'groupId': 'OG002'}, {'value': '252', 'groupId': 'OG003'}, {'value': '92', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '93', 'groupId': 'OG006'}, {'value': '93', 'groupId': 'OG007'}]}], 'categories': [{'title': 'Number of Lesions: 0', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 1-2', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}, {'value': '175', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 3-4', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: 5-6', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}, {'title': 'Number of Lesions: >6', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '53', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.1097', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Tissue Site: Bone', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1087', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Tissue Site: Bone', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1949', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Tissue Site: Bone', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1315', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Tissue Site: Bone', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1977', 'groupIds': ['OG004', 'OG006'], 'groupDescription': 'Tissue Site: Bone', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2149', 'groupIds': ['OG004', 'OG007'], 'groupDescription': 'Tissue Site: Bone', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2582', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Tissue Site: Visceral/Soft tissue', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Tissue Site: Visceral/Soft tissue', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3588', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Tissue Site: Visceral/Soft tissue', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8791', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Tissue Site: Visceral/Soft tissue', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9457', 'groupIds': ['OG004', 'OG006'], 'groupDescription': 'Tissue Site: Visceral/Soft tissue', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2705', 'groupIds': ['OG004', 'OG007'], 'groupDescription': 'Tissue Site: Visceral/Soft tissue', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Tissue Type: Lymph nodes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Tissue Type: Lymph nodes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Tissue Type: Lymph nodes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5933', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Tissue Type: Lymph nodes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7094', 'groupIds': ['OG004', 'OG006'], 'groupDescription': 'Tissue Type: Lymph nodes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5424', 'groupIds': ['OG004', 'OG007'], 'groupDescription': 'Tissue Type: Lymph nodes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Tissue Site: Prostate Gland', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Tissue Site: Prostate Gland', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Tissue Site: Prostate Gland', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0038', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Tissue Site: Prostate Gland', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0647', 'groupIds': ['OG004', 'OG006'], 'groupDescription': 'Tissue Site: Prostate Gland', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0021', 'groupIds': ['OG004', 'OG007'], 'groupDescription': 'Tissue Site: Prostate Gland', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Tissue Site: All', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Tissue Site: All', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Tissue Site: All', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0815', 'groupIds': ['OG004', 'OG005'], 'groupDescription': 'Tissue Site: All', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7507', 'groupIds': ['OG004', 'OG006'], 'groupDescription': 'Tissue Site: All', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5620', 'groupIds': ['OG004', 'OG007'], 'groupDescription': 'Tissue Site: All', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken', 'description': "The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Set consisted of high risk cancer participants (Cohort A) who received 18F-DCFPyL and had a prostatectomy or lymphadenectomy, and participants with recurrent or metastatic prostate cancer (Cohort B) who received 18F-DCFPyL and had a conventional image-guided biopsy, and had an 18F-DCFPyL PET/CT imaging result and a corresponding histology result.'}, {'type': 'SECONDARY', 'title': 'Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Central Reader 1', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '100.0'}]}]}, {'title': 'Central Reader 2', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '100.0'}]}]}, {'title': 'Central Reader 3', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and had a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.'}, {'type': 'SECONDARY', 'title': 'Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Central Reader 1', 'categories': [{'measurements': [{'value': '0', 'comment': 'NPV was 0 - no participant had negative histology in the prostate.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Central Reader 2', 'categories': [{'measurements': [{'value': '0', 'comment': 'NPV was 0 - no participant had negative histology in the prostate.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Central Reader 3', 'categories': [{'measurements': [{'value': '0', 'comment': 'NPV was 0 - no participant had negative histology in the prostate.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.'}, {'type': 'SECONDARY', 'title': 'Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Central Reader 1', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '69.7', 'upperLimit': '95.3'}]}]}, {'title': 'Central Reader 2', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '98.6'}]}]}, {'title': 'Central Reader 3', 'categories': [{'measurements': [{'value': '78.1', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '92.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.'}, {'type': 'SECONDARY', 'title': 'Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Central Reader 1', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '78.9', 'upperLimit': '88.6'}]}]}, {'title': 'Central Reader 2', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '86.4'}]}]}, {'title': 'Central Reader 3', 'categories': [{'measurements': [{'value': '83.2', 'groupId': 'OG000', 'lowerLimit': '78.2', 'upperLimit': '88.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Set of high risk prostate cancer participants (Cohort A) includes those who received 18F-DCFPyL, had a prostatectomy or lymphadenectomy, and provided a 18F-DCFPyL PET/CT image result and a corresponding histopathology result.'}, {'type': 'SECONDARY', 'title': 'Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'classes': [{'title': 'Central Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '89.5'}]}]}, {'title': 'Central Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.9', 'groupId': 'OG000', 'lowerLimit': '73.7', 'upperLimit': '90.2'}]}]}, {'title': 'Central Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '95.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.', 'description': 'Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Evaluable Set consisted of participants in Cohort B who received 18F-DCFPyl, had an 18F-DCFPyL PET/CT imaging result, had a conventional image-guided biopsy and a corresponding histology result.'}, {'type': 'SECONDARY', 'title': 'Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic Subset of High Risk Prostate Cancer Participants (Cohort A)', 'description': 'A subset of high risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) participated in the pharmacokinetic portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.43', 'spread': '0.088', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.', 'unitOfMeasure': 'µCi/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pharmacokinetic Subset of High Risk Prostate Cancer Participants (Cohort A)', 'description': 'A subset of high risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) participated in the pharmacokinetic portion of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.82', 'spread': '0.143', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.', 'unitOfMeasure': 'h*μCi/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Ten (10) participants from a single investigational site with high risk localized prostate cancer scheduled to undergo radical prostatectomy with pelvic lymph node dissection (Cohort A) agreed and were consented to participate in the PK portion of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}, {'id': 'FG001', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '248'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Risk Prostate Cancer (Cohort A)', 'description': 'Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}, {'id': 'BG001', 'title': 'Recurrent or Metastatic Prostate Cancer (Cohort B)', 'description': 'Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '84'}, {'value': '68', 'groupId': 'BG001', 'lowerLimit': '45', 'upperLimit': '86'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population; total number of patients who received 18F-DCFPyL injection.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-06', 'size': 756501, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-15T14:49', 'hasProtocol': True}, {'date': '2018-09-05', 'size': 1339050, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-16T12:14', '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': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'dispFirstSubmitDate': '2019-09-12', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2016-11-22', 'dispFirstSubmitQcDate': '2019-09-12', 'resultsFirstSubmitDate': '2021-05-16', 'studyFirstSubmitQcDate': '2016-11-30', 'dispFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-06', 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.'}, {'measure': 'Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.'}], 'secondaryOutcomes': [{'measure': 'Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)', 'timeFrame': 'From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).', 'description': 'Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.'}, {'measure': 'Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)', 'timeFrame': 'From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).', 'description': 'Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.'}, {'measure': 'Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)', 'timeFrame': 'Changes in ECG pre-drug dosing and within 1-2 hours post-dosing'}, {'measure': 'Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)', 'timeFrame': 'Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.'}, {'measure': 'Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)', 'timeFrame': 'Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.'}, {'measure': 'Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)', 'timeFrame': 'Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.'}, {'measure': 'Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)', 'timeFrame': 'Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.'}, {'measure': 'Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)', 'timeFrame': 'Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.', 'description': 'Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).'}, {'measure': 'Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging', 'timeFrame': 'Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken', 'description': "The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results."}, {'measure': 'Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.'}, {'measure': 'Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.'}, {'measure': 'Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.'}, {'measure': 'Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)', 'timeFrame': 'Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.', 'description': 'Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.'}, {'measure': 'Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)', 'timeFrame': 'Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.', 'description': 'Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.'}, {'measure': 'Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants', 'timeFrame': 'Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants', 'timeFrame': 'Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diagnostic', 'Imaging', '2301', 'PET/CT', 'PyL', 'PSMA', 'radical prostatectomy', 'metastatic prostate cancer', 'recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B).\n\nCohort B is complete and no longer recruiting subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the prostate.\n2. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.\n\nCohort A Only:\n\n* At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA \\>20 ng/mL or Gleason score ≥8).\n* Scheduled or planned radical prostatectomy with PLND.\n\nCohort B Only: \\[Enrollment is complete; No longer recruiting subjects\\]\n\n* Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.\n* If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed.\n* Scheduled or planned percutaneous biopsy of at least one amenable lesion.\n\nExclusion Criteria:\n\n1. Subjects administered any high energy (\\>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.\n2. Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.\n\nCohort A Only:\n\n* Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention\n\nCohort B Only: \\[Enrollment is Complete; No longer recruiting subjects\\]\n\n* Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed\n* Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.'}, 'identificationModule': {'nctId': 'NCT02981368', 'acronym': 'OSPREY', 'briefTitle': 'Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Progenics Pharmaceuticals, Inc.'}, 'officialTitle': 'A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)', 'orgStudyIdInfo': {'id': 'PyL 2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-DCFPyL Injection', 'description': '9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL', 'interventionNames': ['Drug: 18F-DCFPyL Injection', 'Diagnostic Test: PET/CT imaging']}], 'interventions': [{'name': '18F-DCFPyL Injection', 'type': 'DRUG', 'otherNames': ['PyL'], 'description': 'A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL', 'armGroupLabels': ['18F-DCFPyL Injection']}, {'name': 'PET/CT imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'PET/CT imaging will be acquired 1-2 hours post-PyL injection', 'armGroupLabels': ['18F-DCFPyL Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco (UCSF) - Mt. Zion Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University Department of Radiology and Biomedical Imaging', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Mallinckrodt Institute of Radilogy', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Quebec (CHUQ)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Michael J Morris, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}, {'name': 'Kenneth J Pienta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Progenics Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}