Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT03490032
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2018-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'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': 'D011469', 'term': 'Prostatic Diseases'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.', 'description': 'Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.', 'eventGroups': [{'id': 'EG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'seriousEvents': [{'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'Treatment-Emergent Adverse Events (TEAEs)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Deaths Due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'dosing through 28 days post-dose', 'description': 'Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'Brain@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002196', 'spread': '0.0009359', 'groupId': 'OG000'}]}]}, {'title': 'Brain@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001913', 'spread': '0.0003011', 'groupId': 'OG000'}]}]}, {'title': 'Brain@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001310', 'spread': '0.0005902', 'groupId': 'OG000'}]}]}, {'title': 'Brain@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001279', 'spread': '0.0007786', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.009010', 'spread': '0.0014472', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.006371', 'spread': '0.0012260', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004330', 'spread': '0.0014781', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003209', 'spread': '0.0014961', 'groupId': 'OG000'}]}]}, {'title': 'Kidney@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.033219', 'spread': '0.0140235', 'groupId': 'OG000'}]}]}, {'title': 'Kidney@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.022069', 'spread': '0.0090106', 'groupId': 'OG000'}]}]}, {'title': 'Kidney@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.018424', 'spread': '0.0068331', 'groupId': 'OG000'}]}]}, {'title': 'Kidney@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.015772', 'spread': '0.0069341', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000016', 'spread': '0.0000023', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000016', 'spread': '0.0000051', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000015', 'spread': '0.0000045', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000014', 'spread': '0.0000074', 'groupId': 'OG000'}]}]}, {'title': 'Liver@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.040546', 'spread': '0.0098781', 'groupId': 'OG000'}]}]}, {'title': 'Liver@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.030958', 'spread': '0.0073605', 'groupId': 'OG000'}]}]}, {'title': 'Liver@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.023145', 'spread': '0.0083627', 'groupId': 'OG000'}]}]}, {'title': 'Liver@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.018128', 'spread': '0.0081345', 'groupId': 'OG000'}]}]}, {'title': 'Lungs@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.010066', 'spread': '0.0017280', 'groupId': 'OG000'}]}]}, {'title': 'Lungs@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007535', 'spread': '0.0013048', 'groupId': 'OG000'}]}]}, {'title': 'Lungs@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005023', 'spread': '0.0015987', 'groupId': 'OG000'}]}]}, {'title': 'Lungs@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003601', 'spread': '0.0016623', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002001', 'spread': '0.0004118', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001585', 'spread': '0.0004877', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001282', 'spread': '0.0006661', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001032', 'spread': '0.0005455', 'groupId': 'OG000'}]}]}, {'title': 'Spleen@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003712', 'spread': '0.0010597', 'groupId': 'OG000'}]}]}, {'title': 'Spleen@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002645', 'spread': '0.0008966', 'groupId': 'OG000'}]}]}, {'title': 'Spleen@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001724', 'spread': '0.0007601', 'groupId': 'OG000'}]}]}, {'title': 'Spleen@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001264', 'spread': '0.0006056', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000378', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000266', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000201', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000128', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)', 'description': 'PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.', 'unitOfMeasure': 'mSv/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). Only participants with a value at each post-injection timepoints were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Phase I: Urinary Excretion of [68Ga]-PSMA-R2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '5870', 'spread': '1820', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 6 hours post-dose', 'description': 'Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics.', 'unitOfMeasure': 'mL/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Phase I: Half-life of 68Ga-PSMA-R2 in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'spread': '0.868', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 6 hours post-dose', 'description': 'Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T\\^1/2) for the analyte in blood was summarized with descriptive statistics.', 'unitOfMeasure': 'Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'Brain@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001686', 'spread': '0.0007242', 'groupId': 'OG000'}]}]}, {'title': 'Brain@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001046', 'spread': '0.0000814', 'groupId': 'OG000'}]}]}, {'title': 'Brain@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000423', 'spread': '0.0001630', 'groupId': 'OG000'}]}]}, {'title': 'Brain@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000222', 'spread': '0.0000924', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.006914', 'spread': '0.0011156', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003484', 'spread': '0.0004766', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001332', 'spread': '0.0002056', 'groupId': 'OG000'}]}]}, {'title': 'Heart Wall@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000542', 'spread': '0.0001255', 'groupId': 'OG000'}]}]}, {'title': 'Kidney@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.025506', 'spread': '0.0107777', 'groupId': 'OG000'}]}]}, {'title': 'Kidney@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.012059', 'spread': '0.0043426', 'groupId': 'OG000'}]}]}, {'title': 'Kidney@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.005825', 'spread': '0.0015596', 'groupId': 'OG000'}]}]}, {'title': 'Kidney@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002766', 'spread': '0.0006581', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000012', 'spread': '0.0000019', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000009', 'spread': '0.0000022', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000005', 'spread': '0.0000011', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000002', 'spread': '0.0000008', 'groupId': 'OG000'}]}]}, {'title': 'Liver@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.031128', 'spread': '0.0076342', 'groupId': 'OG000'}]}]}, {'title': 'Liver@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.016949', 'spread': '0.0032692', 'groupId': 'OG000'}]}]}, {'title': 'Liver@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007172', 'spread': '0.0014994', 'groupId': 'OG000'}]}]}, {'title': 'Liver@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.003087', 'spread': '0.0006828', 'groupId': 'OG000'}]}]}, {'title': 'Lungs@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007729', 'spread': '0.0013599', 'groupId': 'OG000'}]}]}, {'title': 'Lungs@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004149', 'spread': '0.0006660', 'groupId': 'OG000'}]}]}, {'title': 'Lungs@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001573', 'spread': '0.0002652', 'groupId': 'OG000'}]}]}, {'title': 'Lungs@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000631', 'spread': '0.0001601', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001536', 'spread': '0.0003192', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000859', 'spread': '0.0002093', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000386', 'spread': '0.0001469', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000173', 'spread': '0.0000550', 'groupId': 'OG000'}]}]}, {'title': 'Spleen@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002849', 'spread': '0.0008140', 'groupId': 'OG000'}]}]}, {'title': 'Spleen@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.001444', 'spread': '0.0004213', 'groupId': 'OG000'}]}]}, {'title': 'Spleen@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000536', 'spread': '0.0001640', 'groupId': 'OG000'}]}]}, {'title': 'Spleen@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000217', 'spread': '0.0000567', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid@20-30 minutes post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000289', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid@1 hour post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000136', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid@2 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000057', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid@3-4 hours post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000020', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)', 'description': 'PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.', 'unitOfMeasure': 'mSv/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). Only participants with a value at each post-injection timepoints were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Phase I: Residence Times in Normal Organs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'Brain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002895', 'spread': '0.0009849', 'groupId': 'OG000'}]}]}, {'title': 'Heart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.010459', 'spread': '0.0014152', 'groupId': 'OG000'}]}]}, {'title': 'Kidney', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.039360', 'spread': '0.0133500', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000027', 'spread': '0.0000052', 'groupId': 'OG000'}]}]}, {'title': 'Liver', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.050735', 'spread': '0.0103951', 'groupId': 'OG000'}]}]}, {'title': 'Lungs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.012084', 'spread': '0.0019321', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.002594', 'spread': '0.0006622', 'groupId': 'OG000'}]}]}, {'title': 'Spleen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004291', 'spread': '0.0012416', 'groupId': 'OG000'}]}]}, {'title': 'Thyroid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000424', 'spread': 'NA', 'comment': 'Only one participant analyzed', 'groupId': 'OG000'}]}]}, {'title': 'Urinary Bladder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.092947', 'spread': '0.0453608', 'groupId': 'OG000'}]}]}, {'title': 'Remainder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.417135', 'spread': '0.0582923', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1', 'description': 'Residence times of radiation in normal organs were summarized with descriptive statistics.', 'unitOfMeasure': 'MBq-hr/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). For each parameter, only participants with a value are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Phase I: Absorbed Dose of 68Ga-PSMA-R2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'Brain', 'categories': [{'measurements': [{'value': '0.002563', 'spread': '0.000336', 'groupId': 'OG000'}]}]}, {'title': 'Heart', 'categories': [{'measurements': [{'value': '0.018417', 'spread': '0.0020094', 'groupId': 'OG000'}]}]}, {'title': 'Kidney', 'categories': [{'measurements': [{'value': '0.060683', 'spread': '0.0190588', 'groupId': 'OG000'}]}]}, {'title': 'Lacrimal Gland', 'categories': [{'measurements': [{'value': '0.008065', 'spread': '0.0015741', 'groupId': 'OG000'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '0.017417', 'spread': '0.0029976', 'groupId': 'OG000'}]}]}, {'title': 'Lungs', 'categories': [{'measurements': [{'value': '0.007967', 'spread': '0.0007718', 'groupId': 'OG000'}]}]}, {'title': 'Red Marrow', 'categories': [{'measurements': [{'value': '0.010700', 'spread': '0.0002280', 'groupId': 'OG000'}]}]}, {'title': 'Salivary Gland', 'categories': [{'measurements': [{'value': '0.015600', 'spread': '0.0032012', 'groupId': 'OG000'}]}]}, {'title': 'Spleen', 'categories': [{'measurements': [{'value': '0.017333', 'spread': '0.0037109', 'groupId': 'OG000'}]}]}, {'title': 'Urinary Bladder', 'categories': [{'measurements': [{'value': '0.120317', 'spread': '0.0517023', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1', 'description': 'Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics.', 'unitOfMeasure': 'mGy/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS).'}, {'type': 'SECONDARY', 'title': 'Phase I: Whole-body Dose of 68Ga-PSMA-R2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '0.013800', 'spread': '0.0000632', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1', 'description': 'The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.', 'unitOfMeasure': 'mGy/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Phase I: Effective Dose of 68Ga-PSMA-R2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'categories': [{'measurements': [{'value': '0.014583', 'spread': '0.0019343', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1', 'description': 'The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.', 'unitOfMeasure': 'mSv/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'PET (1hr): SUVmax (lesion)', 'categories': [{'measurements': [{'value': '4.493', 'spread': '1.4060', 'groupId': 'OG000'}, {'value': '4.421', 'spread': '1.4512', 'groupId': 'OG001'}, {'value': '6.725', 'spread': '5.5327', 'groupId': 'OG002'}]}]}, {'title': 'PET (1hr): SUVmean (background)', 'categories': [{'measurements': [{'value': '0.980', 'spread': '0.0283', 'groupId': 'OG000'}, {'value': '0.643', 'spread': '0.2318', 'groupId': 'OG001'}, {'value': '0.750', 'spread': '0.3002', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): SUVmax (lesion)', 'categories': [{'measurements': [{'value': '3.767', 'spread': '1.1493', 'groupId': 'OG000'}, {'value': '5.098', 'spread': '1.8597', 'groupId': 'OG001'}, {'value': '6.846', 'spread': '4.7745', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): SUVmean (background)', 'categories': [{'measurements': [{'value': '0.630', 'spread': '0.3145', 'groupId': 'OG000'}, {'value': '0.651', 'spread': '0.2817', 'groupId': 'OG001'}, {'value': '0.550', 'spread': '0.1948', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.', 'unitOfMeasure': 'Standard Uptake Value (SUV)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'PET (1hr): TBR', 'categories': [{'measurements': [{'value': '4.520', 'spread': '1.3558', 'groupId': 'OG000'}, {'value': '7.464', 'spread': '3.0364', 'groupId': 'OG001'}, {'value': '11.141', 'spread': '10.6283', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): TBR', 'categories': [{'measurements': [{'value': '5.694', 'spread': '1.7104', 'groupId': 'OG000'}, {'value': '7.780', 'spread': '3.6034', 'groupId': 'OG001'}, {'value': '12.588', 'spread': '9.1146', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'PET (1hr): SUVmax (lesion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.087', 'spread': '4.9133', 'groupId': 'OG002'}]}]}, {'title': 'PET (1hr): SUVmean (background)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.689', 'spread': '0.1955', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): SUVmax (lesion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.647', 'spread': '5.3409', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): SUVmean (background)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.541', 'spread': '0.2234', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.', 'unitOfMeasure': 'Standard Uptake Value (SUV)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). Only participants with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'PET (1hr): TBR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.573', 'spread': '10.2632', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): TBR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.880', 'spread': '10.1991', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS). Only participants with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'PET (1hr): SUVmax (lesion)', 'categories': [{'measurements': [{'value': '4.493', 'spread': '1.4060', 'groupId': 'OG000'}, {'value': '4.421', 'spread': '1.4512', 'groupId': 'OG001'}, {'value': '6.578', 'spread': '5.8224', 'groupId': 'OG002'}]}]}, {'title': 'PET (1hr): SUVmean (background)', 'categories': [{'measurements': [{'value': '0.980', 'spread': '0.0283', 'groupId': 'OG000'}, {'value': '0.643', 'spread': '0.2318', 'groupId': 'OG001'}, {'value': '0.723', 'spread': '0.3020', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): SUVmax (lesion)', 'categories': [{'measurements': [{'value': '3.767', 'spread': '1.1493', 'groupId': 'OG000'}, {'value': '5.098', 'spread': '1.8597', 'groupId': 'OG001'}, {'value': '6.566', 'spread': '4.5956', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): SUVmean (background)', 'categories': [{'measurements': [{'value': '0.630', 'spread': '0.3145', 'groupId': 'OG000'}, {'value': '0.651', 'spread': '0.2817', 'groupId': 'OG001'}, {'value': '0.581', 'spread': '0.2119', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.', 'unitOfMeasure': 'Standard Uptake Value (SUV)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'PET (1hr): TBR', 'categories': [{'measurements': [{'value': '4.520', 'spread': '1.3558', 'groupId': 'OG000'}, {'value': '7.464', 'spread': '3.0364', 'groupId': 'OG001'}, {'value': '10.965', 'spread': '10.9067', 'groupId': 'OG002'}]}]}, {'title': 'PET (2hr): TBR', 'categories': [{'measurements': [{'value': '5.694', 'spread': '1.7104', 'groupId': 'OG000'}, {'value': '7.780', 'spread': '3.6034', 'groupId': 'OG001'}, {'value': '11.788', 'spread': '8.6914', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'OG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'PET(1hr): Positive percent agreement', 'categories': [{'measurements': [{'value': '0.0', 'comment': 'Not calculated, 0 participants with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'Not calculated, 0 participants with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '87.5', 'groupId': 'OG002', 'lowerLimit': '47.35', 'upperLimit': '99.68'}]}]}, {'title': 'PET(1hr): Negative percent agreement', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': '57.19'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '60.24'}]}]}, {'title': 'PET(1hr): Overall percent agreement', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '22.28', 'upperLimit': '95.67'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': '57.19'}, {'value': '58.3', 'groupId': 'OG002', 'lowerLimit': '27.67', 'upperLimit': '84.83'}]}]}, {'title': 'PET(2hr): Positive percent agreement', 'categories': [{'measurements': [{'value': '0.0', 'comment': 'Not calculated, 0 participants with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'Not calculated, 0 participants with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '87.5', 'groupId': 'OG002', 'lowerLimit': '47.35', 'upperLimit': '99.68'}]}]}, {'title': 'PET(2hr): Negative percent agreement', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '4.33', 'upperLimit': '77.72'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': '57.19'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '6.76', 'upperLimit': '93.24'}]}]}, {'title': 'PET(2hr): Overall percent agreement', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '4.33', 'upperLimit': '77.72'}, {'value': '5.49', 'groupId': 'OG001', 'lowerLimit': '5.49', 'upperLimit': '57.19'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '42.81', 'upperLimit': '94.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows:\n\n* Positive percent agreement: a/(a+c) × 100\n* Negative percent agreement: d/(b+d) × 100\n* Overall percent agreement: (a+d)/(a+b+c+d) × 100\n\nWhere:\n\n* a = number of subjects with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET scan\n* b = number of subjects with at least 1 positive lesion detected by PET scan that was not correlated with conventional scan\n* c = number of subjects with at least 1 positive lesion detected by conventional scan that was not correlated with PET scan\n* d = number of subjects with no lesions detected by conventional scan or PET scan.', 'unitOfMeasure': 'Percent Agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}, {'type': 'SECONDARY', 'title': 'Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'classes': [{'title': 'PET (positive)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Conventional (postive)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Difference = PET(+) - Conventional(+)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'PET(+) and detected by conventional scan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'PET+/detected by CT:Bone,Cervical Spine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/detected by CT:Bone,Lumbar Spine', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'PET+/detected by CT:Bone,Thoracic Spine', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'PET+/detected by CT:Pelvic Bone', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'PET+/detected by CT:Pelvis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/detected by CT:Rib(s),L.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/detected by CT:Rib(s),R.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET(+) and not detected by conventional scan', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Abdominal Wall', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Bone,Lumbar Spine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Bone,Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Bone,Thoracic Spine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Lymph Node,Common Iliac', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Lymph Node,External', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Lymph Node,Inguinal,L.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Lymph Node,Inguinal,R.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Lymph Node,Para-Aortic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Lymph Node,Retrocrural', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Lymph Node,Retroperitoneal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Lymph Node,Supraclavicular,L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Other,Extranodal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Other,Nodal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Pelvic Bone', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Rib(s),L.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Rib(s),R.', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'PET+/undetected by CT:Urethra', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Conventional (+) and not detected by PET scan', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'CT+/undetected by PET:Bone,Lumbar Spine', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CT+/undetected by PET:Bone,Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CT+/undetected by PET:Bone,Thoracic Spine', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'CT+/undetected by PET:Lymph Node,Pelvic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CT+/undetected by PET:Pelvic Bone', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'CT+/undetected by PET:Rib(s),L.', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'CT+/undetected by PET:Rib(s),R.', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'CT+/undetected by PET:Skull', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection)', 'description': 'The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics.', 'unitOfMeasure': 'Positive Lesion', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'FG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'FG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All enrolled patients were included in the Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'family issue (child custody)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 5 centers in the USA (Phase I: 1 site; Phase II: 4 sites)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'BG001', 'title': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'BG002', 'title': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '7.91', 'groupId': 'BG000'}, {'value': '69.1', 'spread': '6.53', 'groupId': 'BG001'}, {'value': '68.6', 'spread': '10.00', 'groupId': 'BG002'}, {'value': '68.3', 'spread': '8.13', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status', 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': '> = Grade 1', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classifies participants according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). ECOG PS: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.', 'unitOfMeasure': 'Participants'}, {'title': 'Prostate-specific antigen (PSA) levels', 'classes': [{'categories': [{'measurements': [{'value': '1.68', 'spread': '1.329', 'groupId': 'BG000'}, {'value': '3.72', 'spread': '6.461', 'groupId': 'BG001'}, {'value': '38.56', 'spread': '66.603', 'groupId': 'BG002'}, {'value': '17.25', 'spread': '44.861', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since first prostate cancer diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'spread': '46.44', 'groupId': 'BG000'}, {'value': '86.8', 'spread': '78.07', 'groupId': 'BG001'}, {'value': '96.1', 'spread': '84.80', 'groupId': 'BG002'}, {'value': '88.8', 'spread': '73.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Time since first prostate cancer diagnosis is defined as (date of screening - date of first prostate cancer diagnosis + 1) / 30.4375.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since first metastasis', 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'spread': '46.44', 'groupId': 'BG000'}, {'value': '86.8', 'spread': '78.07', 'groupId': 'BG001'}, {'value': '96.1', 'spread': '84.80', 'groupId': 'BG002'}, {'value': '88.8', 'spread': '73.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Time since first metastasis is defined as (date of screening - date of first metastasis + 1)/ 30.4375.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since disease progression', 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'spread': '33.02', 'groupId': 'BG000'}, {'value': '1.2', 'spread': '1.55', 'groupId': 'BG001'}, {'value': '0.8', 'spread': '0.65', 'groupId': 'BG002'}, {'value': '5.8', 'spread': '16.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Time since disease progression is defined as (date of screening - date of disease progression + 1)/ 30.4375.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of patients by castration type', 'classes': [{'title': 'Surgery', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Pharmacological', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Not Applicable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of patients by Primary and Secondary Gleason score', 'classes': [{'title': 'Primary Gleason score=3 &Secondary Gleason score=3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Primary Gleason score=3 &Secondary Gleason score=4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Primary Gleason score=4 &Secondary Gleason score=3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Primary Gleason score=4 &Secondary Gleason score=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Primary Gleason score=4 &Secondary Gleason score=5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Gleason score is based on biopsy samples taken from the prostate. Both a primary and a secondary pattern of tissue organization are identified. The primary pattern represents the most common tissue pattern seen in the tumor, and the secondary pattern represents the next most common pattern. Each pattern is given a grade from 1 to 5, with 1 looking the most like normal prostate tissue and 5 looking the most abnormal. The two grades are then added to give a Gleason score.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of patients by Total Gleason score (>=6)', 'classes': [{'categories': [{'title': '6', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': '7', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': '8', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': '9', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': '10', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gleason score can range from 2-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. Scores of 6 (or less) describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. A score of 7 suggests an intermediate risk for aggressive cancer. Scores of 8 (or higher) describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade.', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Weight', 'classes': [{'categories': [{'measurements': [{'value': '91.48', 'spread': '18.091', 'groupId': 'BG000'}, {'value': '87.03', 'spread': '18.838', 'groupId': 'BG001'}, {'value': '93.20', 'spread': '11.402', 'groupId': 'BG002'}, {'value': '90.29', 'spread': '15.890', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Height', 'classes': [{'categories': [{'measurements': [{'value': '183.00', 'spread': '5.030', 'groupId': 'BG000'}, {'value': '177.96', 'spread': '6.596', 'groupId': 'BG001'}, {'value': '177.03', 'spread': '5.927', 'groupId': 'BG002'}, {'value': '178.65', 'spread': '6.281', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration.', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-29', 'size': 8656884, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-10T12:23', 'hasProtocol': False}, {'date': '2018-02-22', 'size': 1855975, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-10T18:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase I: characterize PK and dosimetry Phase II: diagnostic potential in 2 groups\n\n1. Prostate Cancer in biochemical relapse, and\n2. Metastatic Prostate Cancer'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2019-10-25', 'completionDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2018-03-26', 'dispFirstSubmitQcDate': '2020-10-26', 'resultsFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2018-04-05', 'dispFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-26', 'studyFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': 'dosing through 28 days post-dose', 'description': 'Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.'}], 'secondaryOutcomes': [{'measure': 'Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)', 'description': 'PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.'}, {'measure': 'Phase I: Urinary Excretion of [68Ga]-PSMA-R2', 'timeFrame': '0 to 6 hours post-dose', 'description': 'Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics.'}, {'measure': 'Phase I: Half-life of 68Ga-PSMA-R2 in Blood', 'timeFrame': '0 to 6 hours post-dose', 'description': 'Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T\\^1/2) for the analyte in blood was summarized with descriptive statistics.'}, {'measure': 'Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection)', 'description': 'PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed.'}, {'measure': 'Phase I: Residence Times in Normal Organs', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1', 'description': 'Residence times of radiation in normal organs were summarized with descriptive statistics.'}, {'measure': 'Phase I: Absorbed Dose of 68Ga-PSMA-R2', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1', 'description': 'Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics.'}, {'measure': 'Phase I: Whole-body Dose of 68Ga-PSMA-R2', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1', 'description': 'The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.'}, {'measure': 'Phase I: Effective Dose of 68Ga-PSMA-R2', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1', 'description': 'The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics.'}, {'measure': 'Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.'}, {'measure': 'Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.'}, {'measure': 'Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.'}, {'measure': 'Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.'}, {'measure': 'Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points.'}, {'measure': 'Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points.'}, {'measure': 'Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection)', 'description': 'The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows:\n\n* Positive percent agreement: a/(a+c) × 100\n* Negative percent agreement: d/(b+d) × 100\n* Overall percent agreement: (a+d)/(a+b+c+d) × 100\n\nWhere:\n\n* a = number of subjects with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET scan\n* b = number of subjects with at least 1 positive lesion detected by PET scan that was not correlated with conventional scan\n* c = number of subjects with at least 1 positive lesion detected by conventional scan that was not correlated with PET scan\n* d = number of subjects with no lesions detected by conventional scan or PET scan.'}, {'measure': 'Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall)', 'timeFrame': '68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection)', 'description': 'The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostatic Neoplasms', 'Cancer of Prostate', 'Cancer of the Prostate', 'Neoplasms, Prostate', 'Prostate Cancer', 'Prostatic Cancer', 'Genital Neoplasms, Male', 'Urogenital Neoplasms', 'Neoplasms by Site', 'Neoplasms', 'Genital Diseases, Male', 'Prostatic Diseases', 'PSMA', 'Prostate-specific membrane antigen', 'Gallium radioisotope 68', '68Ga-PSMA-R2', '68Ga-PSMA ligand'], 'conditions': ['Prostate Cancer Metastatic']}, 'descriptionModule': {'briefSummary': 'This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).', 'detailedDescription': 'This study consisted of 2 parts.\n\n* During the first part (Phase I) of the study, 6 subjects with biochemically recurrent prostate cancer (PCa) received the investigational product (IP) and remained at the site for approximately 6 hours post-administration in order to assess the PK, biodistribution versus time, and dosimetry for critical organs. Subjects received a single dose of 3 MBq/kg, (\\>=150 and =\\<250 MBq), of 68\\^Ga-PSMA-R2 intravenously. Serial blood and urine samples were collected for PK characterization and dosimetry and whole-body PET/CT were acquired at selected time points (0 to 4 hours) to determine organ and tumor absorbed doses. Safety assessments were conducted after IP administration on Day 1, and during follow-up on Days 7 and 28.\n* In the second part of the study (Phase II), 2 groups of 12 subjects were enrolled (subjects with PCa in biochemical recurrence \\[PCa-BR\\], and subjects with prostate cancer in the metastatic stage \\[mPCa\\]). Based on the preliminary data analysis from the Phase I part of the study provided sufficient dosimetry data, all subjects underwent the whole body PET/CT imaging optimized for time (up to 2 time points) according to the data analysis from the Phase I part of the study.\n\nThis study was comprised of 4 clinical visits and conducted in 3 study periods: screening, administration/imaging, and safety follow-up period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males 18 years or older.\n2. Signed and dated written informed consent by the subject prior to any study-specific procedures.\n3. Histologically confirmed adenocarcinoma of the prostate, defined as follows:\n\n 1. Biochemical recurrence: defined as PSA is ≥0.2 ng/mL after radical prostatectomy or PSA nadir plus 2 ng/mL after radiation therapy with corresponding CT/MRI or bone scan revealing absence of local recurrence or metastatic lesions.\n\n OR\n 2. Metastatic disease: defined as both, castration-sensitive or castration-resistant mPCa (presence of at least 1 metastatic lymph node, visceral metastasis and/or bone metastasis).\n 3. At least 2 weeks must have elapsed between last anticancer treatment administration and the administration of the imaging product, 68Ga-PSMA-R2.\n4. Prior major surgery must be at least 12 weeks prior to study entry.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, with a life expectancy ≥6 months.\n6. Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening:\n\n 1. Hemoglobin (Hb): \\>8 g/dL\n 2. Platelet count of \\>50.000/mm3\n7. Serum creatinine \\<1.5\\*upper limit normal (ULN) or estimated glomerular filtration rate (eGFR) \\>50 mL/min based upon The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n8. For male subjects with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 28 days after IP administration.\n\nExclusion Criteria:\n\n1. Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any other histologies different than adenocarcinoma.\n2. Administered a radioisotope =\\<10 physical half-lives prior to the day of PET/CT.\n3. Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or need of indwelling/condom catheters.\n4. Uncontrolled pain or incompatibility that results in subject's lack of compliance with imaging procedures.\n5. Other known coexisting malignancies except non-melanoma skin or low grade superficial bladder cancer unless definitively treated and proven no evidence of recurrence for 5 years.\n6. Subject with known incompatibility to CT scans.\n7. Any evidence of severe or uncontrolled systemic or psychiatric diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol, or active infection including human immunodeficiency virus (HIV) and untreated hepatitis B, hepatitis C. Screening for chronic conditions was not required.\n8. Subjects who have received any investigational agent within the last 28 days were excluded from participation in this study.\n9. Any acute toxicity due to prior chemotherapy and/or radiotherapy that has not resolved according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Studies.\n10. Known allergy, hypersensitivity, or intolerance to the IP or its excipients.\n11. Subject unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for study participation."}, 'identificationModule': {'nctId': 'NCT03490032', 'acronym': 'PROfind', 'briefTitle': '68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Accelerator Applications'}, 'officialTitle': 'A Phase 1/2 Open-label, Multi-center, Safety and Tolerability Study of a Single Dose of 68Ga-PSMA-R2 in Patients With Biochemical Relapse (BR) and Metastatic Prostate Cancer (mPCa)', 'orgStudyIdInfo': {'id': 'A206D-A01-001'}, 'secondaryIdInfos': [{'id': 'CAAA502A12101', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].', 'interventionNames': ['Drug: [68Ga]-PSMA-R2']}, {'type': 'EXPERIMENTAL', 'label': 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].', 'interventionNames': ['Drug: [68Ga]-PSMA-R2']}, {'type': 'EXPERIMENTAL', 'label': 'Metastatic Prostate Cancer (mPCa) (Phase II)', 'description': 'All eligible participants received recommended dose of \\[68Ga\\]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq\\].', 'interventionNames': ['Drug: [68Ga]-PSMA-R2']}], 'interventions': [{'name': '[68Ga]-PSMA-R2', 'type': 'DRUG', 'description': 'radio-labelled PSMA ligand', 'armGroupLabels': ['Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I)', 'Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II)', 'Metastatic Prostate Cancer (mPCa) (Phase II)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85040', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pheonix Molecular Imaging Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco (UCSF)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Smilow Cancer Center at Yale New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health, Warren Grant Magnusen Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Accelerator Applications', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}