Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT01800058
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2013-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'almudena.zapatero@salud.madrid.org', 'phone': '+34 91 520 23 15', 'title': 'Almudena Zapatero, MD PhD', 'organization': 'Hospital Universitario de La Princesa'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 15, 'seriousNumAtRisk': 65, 'deathsNumAffected': 7, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Late urinary symptoms Grade >= 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Late rectal symptoms Grade >= 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Postoperative of colon volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head and neck cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumomia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchoaspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric GIST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ureter cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urethral estenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Circulating Tumor Cells in the Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'classes': [{'title': 'Number of Participants with 0 CTCs', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants with =>1 CTCs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Basal', 'description': 'Initially a cutoff point of \\> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Circulating Tumor Cells in the Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'classes': [{'title': 'Number of Participants with 0 CTCs', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants with =>1 CTCs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'No Data', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-neoadjuvant hormone therapy and prior to radiotherapy', 'description': '(Initially a cutoff point of \\> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Circulating Tumor Cells in the Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'classes': [{'title': 'Number of Participants with 0 CTCs', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants with =>1 CTCs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'No Data', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-radiotherapy', 'description': '(Initially a cutoff point of \\> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Circulating Tumor Cells in the Peripheral Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'classes': [{'title': 'Number of Participants with 0 CTCs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Number of Participants with =>1 CTCs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 - 12 months post-radiotherapy in cases with positivation after basal visit', 'description': '(Initially a cutoff point of \\> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with positivation after basal visit'}, {'type': 'SECONDARY', 'title': 'Biochemical Failure-free Survival;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Phoenix criteria (PSA Nadir +2 ng/mL)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '59', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Defined as death due to any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Metastasis-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Defined as freedom from distant metastasis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cause Specific Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '65', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 years', 'description': 'Defined as death caused by prostate cancer', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Circulating Prostatic Tumor Cells in the Peripheral Blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '66 patients included: 2 patients were not included in the final enrollment due to inegibility criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CTCs Analysis', 'description': 'Prospective analysis of biologic samples from PB of 65 patients with localized high-risk PCa (NCCN 2011) treated with RTC-3D-IMRT combined with ADT. Following the sign of the informed consent of the patient, the blood samples will be analyzed for CTCs using an immunomagnetic method based on the CellSearch system in 4 periods of time:\n\n1. Prior to any treatment (baseline- Time 1)\n2. Following ADT and prior to RT (Time 2)\n3. Following the end of RT (1-3 months afterwards) (Time 3)\n4. Following 9 -12 after RT in those cases in cases of one turn (+) in CTCs in the 2nd or 3rd determination'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Median PSA (ng/mL)', 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'BG000', 'lowerLimit': '3.2', 'upperLimit': '68.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'PSA pre-treatment', 'classes': [{'categories': [{'title': '< 10 ng/mL', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '10 - 20 ng/mL', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '> 20 ng/mL', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gleason score', 'classes': [{'title': 'Gleason sum =< 6 Better prognosis', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Gleason sum = 7', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Gleason sum = 8 - 10 Worst prognosis', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical T Stage according to AJCC seventh edition', 'classes': [{'title': 'T1 Best prognosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'T2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'T3 Worst prognosis', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical N Stage according to AJCC seventh edition', 'classes': [{'title': 'N0 Best prognosis', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'N1 Worst prognosis', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Radiotherapy dose (Gy)', 'classes': [{'title': '3D Conformal RT', 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'BG000', 'lowerLimit': '74.8', 'upperLimit': '79.2'}]}]}, {'title': 'IMRT-IGRT', 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'BG000', 'lowerLimit': '70.6', 'upperLimit': '82.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Gy', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-10-10', 'size': 691160, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-25T03:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Prospective analysis of biological material from samples of peripheral blood (PB) of patients with high risk prostate cancer treated with dose escalation RT combined with androgen deprivation (AD)\n\nThe sampling of PB for detection of CTCs was performed at 4 timepoints:\n\n* Before starting any treatment\n* Prior to the start of RT and after neoadjuvant AD\n* At the end of RT (1-3 months)\n* 6-12 months following the end of RT in patients with 0 CTCs in the 1º determination and positive CTCs in the 2º or 3º determination.\n\nA cut off of 0 vs ≥ 1 CTC/7.5 mL blood was defined as a threshold for negative versus positive CTCs status.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2013-02-18', 'resultsFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-25', 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Circulating Tumor Cells in the Peripheral Blood', 'timeFrame': 'Basal', 'description': 'Initially a cutoff point of \\> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline.'}, {'measure': 'Number of Participants With Circulating Tumor Cells in the Peripheral Blood', 'timeFrame': 'Post-neoadjuvant hormone therapy and prior to radiotherapy', 'description': '(Initially a cutoff point of \\> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).'}, {'measure': 'Number of Participants With Circulating Tumor Cells in the Peripheral Blood', 'timeFrame': 'Post-radiotherapy', 'description': '(Initially a cutoff point of \\> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).'}, {'measure': 'Number of Participants With Circulating Tumor Cells in the Peripheral Blood', 'timeFrame': '9 - 12 months post-radiotherapy in cases with positivation after basal visit', 'description': '(Initially a cutoff point of \\> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).'}], 'secondaryOutcomes': [{'measure': 'Biochemical Failure-free Survival;', 'timeFrame': '4 years', 'description': 'Phoenix criteria (PSA Nadir +2 ng/mL)'}, {'measure': 'Overall Survival', 'timeFrame': '4 years', 'description': 'Defined as death due to any cause'}, {'measure': 'Metastasis-free Survival', 'timeFrame': '4 years', 'description': 'Defined as freedom from distant metastasis'}, {'measure': 'Cause Specific Survival', 'timeFrame': '4 years', 'description': 'Defined as death caused by prostate cancer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients With High-risk Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '18486743', 'type': 'BACKGROUND', 'citation': 'Damber JE, Aus G. Prostate cancer. Lancet. 2008 May 17;371(9625):1710-21. doi: 10.1016/S0140-6736(08)60729-1.'}, {'pmid': '18280056', 'type': 'BACKGROUND', 'citation': 'Zelefsky MJ, Yamada Y, Fuks Z, Zhang Z, Hunt M, Cahlon O, Park J, Shippy A. Long-term results of conformal radiotherapy for prostate cancer: impact of dose escalation on biochemical tumor control and distant metastases-free survival outcomes. Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):1028-33. doi: 10.1016/j.ijrobp.2007.11.066. Epub 2008 Feb 14.'}, {'pmid': '17765406', 'type': 'BACKGROUND', 'citation': 'Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.'}, {'pmid': '18172188', 'type': 'BACKGROUND', 'citation': 'Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. doi: 10.1200/JCO.2007.13.9881. Epub 2008 Jan 2.'}, {'pmid': '18413638', 'type': 'BACKGROUND', 'citation': 'Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. doi: 10.1200/JCO.2007.14.9021. Epub 2008 Apr 14.'}, {'pmid': '17404082', 'type': 'BACKGROUND', 'citation': 'Shaffer DR, Leversha MA, Danila DC, Lin O, Gonzalez-Espinoza R, Gu B, Anand A, Smith K, Maslak P, Doyle GV, Terstappen LW, Lilja H, Heller G, Fleisher M, Scher HI. Circulating tumor cell analysis in patients with progressive castration-resistant prostate cancer. Clin Cancer Res. 2007 Apr 1;13(7):2023-9. doi: 10.1158/1078-0432.CCR-06-2701.'}, {'pmid': '17051950', 'type': 'BACKGROUND', 'citation': 'Zapatero A, Rios P, Marin A, Minguez R, Garcia-Vicente F. Dose escalation with three-dimensional conformal radiotherapy for prostate cancer. Is more dose really better in high-risk patients treated with androgen deprivation? Clin Oncol (R Coll Radiol). 2006 Oct;18(8):600-7. doi: 10.1016/j.clon.2006.06.010.'}, {'pmid': '15833514', 'type': 'BACKGROUND', 'citation': 'Moreno JG, Miller MC, Gross S, Allard WJ, Gomella LG, Terstappen LW. Circulating tumor cells predict survival in patients with metastatic prostate cancer. 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Immunomagnetic quantification of circulating tumoral cells in patients with prostate cancer: clinical and pathological correlation. Arch Esp Urol. 2010 Jan-Feb;63(1):23-31.'}, {'pmid': '32487218', 'type': 'RESULT', 'citation': 'Zapatero A, Gomez-Caamano A, Cabeza Rodriguez MA, Muinelo-Romay L, Martin de Vidales C, Abalo A, Calvo Crespo P, Leon Mateos L, Olivier C, Vega Piris LV. Detection and dynamics of circulating tumor cells in patients with high-risk prostate cancer treated with radiotherapy and hormones: a prospective phase II study. Radiat Oncol. 2020 Jun 1;15(1):137. doi: 10.1186/s13014-020-01577-5.'}, {'type': 'RESULT', 'citation': 'A. Zapatero, A. Gomez Caamaño, M. D. L. A. Cabeza Rodriguez, L. Muinelo-Romay, C. Martin de Vidales C, A. Abalo, et al. Monitoring of Circulating Tumor Cells in Patients With High-Risk Nonmetastatic Prostate Cancer Treated With Radiation Therapy and Hormones: Preliminary Data of an Observational Prospective Phase 2 Study. International Journal of Radiation Oncology • Biology • Physics, Vol. 99, Issue 2, E280'}]}, 'descriptionModule': {'briefSummary': 'The detection and quantification of Circulating tumor cells CTCs in peripheral blood of patients with prostate adenocarcinoma may be useful at least for:\n\nGetting a correct stratification of patients with high-risk prostate cancer (PCa).\n\nSet the prognosis at baseline. Evaluate the response to different treatments (predictive value and monitoring).\n\nEstablish individualized therapies.', 'detailedDescription': 'Prospective analysis of biologic samples from peripheral blood of 65 patients with localized high-risk PCa (NCCN 2011) treated with RTC-3D-IMRT combined with AD.\n\nFollowing the sign of the informed consent of the patient, the blood samples will be analyzed for CTCs using an immunomagnetic method based on the CellSearch system (Veridex), in 4 periods of time:\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination\n\nComparison between the expression of CTCs in peripheral blood before and following AD and RT will be performed. The quantification of the CTCs obtained in these phases of treatment will be correlated with the treatment results in terms of biochemical failure according to Phoenix definition, distant metastasis rate and overall survival to identify a significant prognostic relationship and to determine the potential effect of the treatment in the number of CTCs Our working group will include 65 patients because the amount is based on routine clinical activity can be safely enrolled in the project development time by the participating centers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with prostate cancer at high risk (NCCN 2011), AJCC stage IIB-III, treated with 3D-CRT, IMRT dose escalation (with androgen deprivation (DA))', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 18 with capacity to give informed consent.\n* Patients with histologically confirmed prostate cancer.\n* Patients with a high risk factor: PSA\\> 20 ng / ml, Gleason 8-10 and / or stage T3a-b, N0M0 (NCCN 2011, stage IIB-III AJCC classification 2010). Staging by: Histology-Gleason score-, PSA, TR, ECO TR, CT, MRI.\n* Patients who accept radical treatment with radiotherapy.\n* Patients who give written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Any patient diagnosed with prostate cancer, which does not meet the prerequisites.\n* Any patients with another malignancy diagnosed in the past 5 years (except basal cell or squamous cell carcinoma of skin).\n* Any patient who has prostate biopsy performed 7 days prior to study entry.\n* Patients who have received prior treatment with hormonal therapy, chemotherapy or radiotherapy.\n* Patients with PSA\\> 100 ng / ml.\n* Any situation or condition of the patient which in the opinion of the investigator, advised against participation in the study.'}, 'identificationModule': {'nctId': 'NCT01800058', 'briefTitle': 'Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa'}, 'officialTitle': 'Prognostic Value of the Levels of Circulating Tumor Cells (CTCs) in Peripheral Blood in Patients With Prostate Cancer at High Risk (Clinical Stages IIB-III) Treated Radically With Radiotherapy and Hormone Therapy.', 'orgStudyIdInfo': {'id': 'CaPr-RTCTC-01/PI 197'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Circulating prostatic tumor cells in the peripheral blood', 'description': 'Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):\n\n1. prior to any treatment;\n2. following AD and prior to RT; and\n3. following the end of RT (1-3 months afterwards).\n4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination\n\nThe quantification of CTC in blood samples will be done with the CellSearch® system.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Almudena Zapatero, MD, PhD, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radiation Oncology Department_Hospital Universitario de La Princesa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}