Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT02175212
Status:
COMPLETED
Last Update Posted:
2020-11-20
First Post:
2014-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D000277', 'term': 'Adjuvants, Pharmaceutic'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'almudena.zapatero@salud.madrid.org', 'phone': '+34 91 520 23 15', 'title': 'Dr. Almudena Zapatero', 'organization': 'Hospital Universitario de la Princesa; Health Research Institute IIS from Hospital Universitario de la Princesa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '* Relatively short follow-up and low number of events.\n* The lack of patient-reported outcomes.\n* Our decision to include vascular events other than strictly cardiac events (e.g. the presence of CVA or thromboembolic disease).'}}, 'adverseEventsModule': {'timeFrame': '63 months (IQR 50-82)', 'description': 'Maximum toxicity per patient', 'eventGroups': [{'id': 'EG000', 'title': 'Long Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)', 'otherNumAtRisk': 177, 'otherNumAffected': 62, 'seriousNumAtRisk': 177, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Short Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n\nShort term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n\\- Bicalutamide 50 mg tablet every day for 2 months\n\nShort term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)', 'otherNumAtRisk': 178, 'otherNumAffected': 40, 'seriousNumAtRisk': 178, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'Rectal bleeding', 'notes': 'Grade 2 or more according EORTC/RTOG and CTCAE v 3.0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary toxicity', 'notes': 'Grade 2 or more according EORTC/RTOG and CTCAE v 3.0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hot flashes', 'notes': 'Grade 2 or more according EORTC/RTOG and CTCAE v 3.0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Miocardial Infarction/Ischemic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tromboembolic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cerebrovascular accident (CVA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Second malignancies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}, {'id': 'OG001', 'title': 'Short Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n\nShort term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n\\- Bicalutamide 50 mg tablet every day for 2 months\n\nShort term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '92'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '78', 'upperLimit': '81'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '1.12', 'ciUpperLimit': '3.15', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}, {'id': 'OG001', 'title': 'Short Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n\nShort term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n\\- Bicalutamide 50 mg tablet every day for 2 months\n\nShort term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '96'}, {'value': '83', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '86'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.31', 'ciLowerLimit': '1.23', 'ciUpperLimit': '3.85', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival: Estimated Percentage of Participants Alive at 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}, {'id': 'OG001', 'title': 'Short Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n\nShort term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n\\- Bicalutamide 50 mg tablet every day for 2 months\n\nShort term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '97'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '89'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.48', 'ciLowerLimit': '1.31', 'ciUpperLimit': '4.68', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cause-specific Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}, {'id': 'OG001', 'title': 'Short Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n\nShort term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n\\- Bicalutamide 50 mg tablet every day for 2 months\n\nShort term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}], 'classes': [{'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Late Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}, {'id': 'OG001', 'title': 'Short Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n\nShort term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n\\- Bicalutamide 50 mg tablet every day for 2 months\n\nShort term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}], 'classes': [{'title': 'Grade 2 of more rectal toxicity', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2 of more urinary toxicity', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT.\n\nScoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity.\n\nCV events were defined according to the World Health Organization criteria', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Long Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}, {'id': 'FG001', 'title': 'Short Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n\nShort term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n\\- Bicalutamide 50 mg tablet every day for 2 months\n\nShort term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '147'}]}]}], 'recruitmentDetails': 'Between Nov 7, 2005, and Dec 20, 2010, 362 were registered. Of these, seven did not meet the inclusion criteria. The final trial population thus consisted of 355 men, of whom 178 were randomly assigned to the short-term androgen deprivation group and 177 to the long-term androgen deprivation group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Long Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy\n\nLong term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}, {'id': 'BG001', 'title': 'Short Term Androgen Deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n\nShort term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n\n\\- Bicalutamide 50 mg tablet every day for 2 months\n\nShort term androgen deprivation: Minimum dose of 76 Gy (range 76-82 Gy)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '82'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '54', 'upperLimit': '85'}, {'value': '71', 'groupId': 'BG002', 'lowerLimit': '54', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Risk subgroup (intermediate vs. high)', 'classes': [{'title': 'Intermediate', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}]}, {'title': 'High', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'T stage (categorical)', 'classes': [{'title': 'T1: tumor neither palpable not visible by imaging', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'T2: Tumor confinent whitin prostate', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}, {'title': 'T3: Tumor extends through the prostate capsule', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients were staged according to the AJCC Cancer Staging criteria, 6th edition. Intermediate-risk and high-risk factors were defined following the 2005 guidelines of the National Comprehensive Cancer Network.', 'unitOfMeasure': 'participants'}, {'title': 'PSA (continous)', 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'BG000', 'lowerLimit': '3.1', 'upperLimit': '72.0'}, {'value': '11.0', 'groupId': 'BG001', 'lowerLimit': '3.4', 'upperLimit': '66.0'}, {'value': '11', 'groupId': 'BG002', 'lowerLimit': '3.1', 'upperLimit': '72.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'nanogrames per milliliter (ng/mL)', 'dispersionType': 'FULL_RANGE'}, {'title': 'PSA (categorical)', 'classes': [{'title': '<10 ng/mL', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}, {'title': '10-20 ng/mL', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': '>20 ng/mL', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gleason score (categorical)', 'classes': [{'title': '<=6', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': '8-10', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Gleason classification for prostate cancer were used considering Gleason 6 as less aggressive and Gleason 10 most aggressive', 'unitOfMeasure': 'participants'}, {'title': 'Positive biopsy samples (continous)', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '13'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '16'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'number of cylindres', 'dispersionType': 'FULL_RANGE'}, {'title': 'Prostate radiotherapy dose (continous)', 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'groupId': 'BG000', 'lowerLimit': '30.6', 'upperLimit': '88.4'}, {'value': '78.0', 'groupId': 'BG001', 'lowerLimit': '64.0', 'upperLimit': '82.2'}, {'value': '78.0', 'groupId': 'BG002', 'lowerLimit': '30.6', 'upperLimit': '88.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Grays (Gy)', 'dispersionType': 'FULL_RANGE'}, {'title': 'Prostate radiotherapy dose (categorical)', 'classes': [{'title': '<78 Gy', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': '>= 78 Gy', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '173 evaluable patients in short term group and 171 in the long term group', 'unitOfMeasure': 'participants'}, {'title': 'Pelvic radiotherapy (categorical)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '173 evaluable patients in short term group and 171 in the long term group', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2014-06-23', 'resultsFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-16', 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years', 'timeFrame': '5 years', 'description': 'Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).'}], 'secondaryOutcomes': [{'measure': 'Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years', 'timeFrame': '5 years', 'description': 'Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).'}, {'measure': 'Overall Survival: Estimated Percentage of Participants Alive at 5 Years', 'timeFrame': '5 years', 'description': 'Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.'}, {'measure': 'Cause-specific Survival', 'timeFrame': '5 years', 'description': 'Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse'}, {'measure': 'Late Toxicity', 'timeFrame': '5 years', 'description': 'Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT.\n\nScoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity.\n\nCV events were defined according to the World Health Organization criteria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients with prostate adenocarcinoma'], 'conditions': ['Prostate Adenocarcinoma']}, 'referencesModule': {'references': [{'pmid': '12128107', 'type': 'BACKGROUND', 'citation': 'Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, von Eschenbach AC, Kuban DA, Rosen I. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1097-105. doi: 10.1016/s0360-3016(02)02829-8.'}, {'pmid': '9635694', 'type': 'BACKGROUND', 'citation': 'Zelefsky MJ, Leibel SA, Gaudin PB, Kutcher GJ, Fleshner NE, Venkatramen ES, Reuter VE, Fair WR, Ling CC, Fuks Z. Dose escalation with three-dimensional conformal radiation therapy affects the outcome in prostate cancer. Int J Radiat Oncol Biol Phys. 1998 Jun 1;41(3):491-500. doi: 10.1016/s0360-3016(98)00091-1.'}, {'pmid': '11490237', 'type': 'BACKGROUND', 'citation': 'Zelefsky MJ, Fuks Z, Hunt M, Lee HJ, Lombardi D, Ling CC, Reuter VE, Venkatraman ES, Leibel SA. High dose radiation delivered by intensity modulated conformal radiotherapy improves the outcome of localized prostate cancer. J Urol. 2001 Sep;166(3):876-81.'}, {'pmid': '11728678', 'type': 'BACKGROUND', 'citation': 'Vicini FA, Abner A, Baglan KL, Kestin LL, Martinez AA. Defining a dose-response relationship with radiotherapy for prostate cancer: is more really better? Int J Radiat Oncol Biol Phys. 2001 Dec 1;51(5):1200-8. doi: 10.1016/s0360-3016(01)01799-0.'}, {'pmid': '12243818', 'type': 'BACKGROUND', 'citation': "Hanks GE, Hanlon AL, Epstein B, Horwitz EM. Dose response in prostate cancer with 8-12 years' follow-up. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):427-35. doi: 10.1016/s0360-3016(02)02954-1."}, {'pmid': '14571409', 'type': 'BACKGROUND', 'citation': 'Leibel SA, Fuks Z, Zelefsky MJ, Hunt M, Burman CM, Mageras GS, Chui CS, Jackson A, Amols HI, Ling CC. Technological advances in external-beam radiation therapy for the treatment of localized prostate cancer. Semin Oncol. 2003 Oct;30(5):596-615. doi: 10.1016/s0093-7754(03)00354-3.'}, {'pmid': '9276374', 'type': 'BACKGROUND', 'citation': 'Joon DL, Hasegawa M, Sikes C, Khoo VS, Terry NH, Zagars GK, Meistrich ML, Pollack A. Supraadditive apoptotic response of R3327-G rat prostate tumors to androgen ablation and radiation. Int J Radiat Oncol Biol Phys. 1997 Jul 15;38(5):1071-7. doi: 10.1016/s0360-3016(97)00303-9.'}, {'pmid': '9123741', 'type': 'BACKGROUND', 'citation': 'Zietman AL, Prince EA, Nakfoor BM, Shipley WU. Neoadjuvant androgen suppression with radiation in the management of locally advanced adenocarcinoma of the prostate: experimental and clinical results. Urology. 1997 Mar;49(3A Suppl):74-83. doi: 10.1016/s0090-4295(97)00173-8.'}, {'pmid': '12126818', 'type': 'BACKGROUND', 'citation': 'Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.'}, {'pmid': '11483335', 'type': 'BACKGROUND', 'citation': 'Pilepich MV, Winter K, John MJ, Mesic JB, Sause W, Rubin P, Lawton C, Machtay M, Grignon D. Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1243-52. doi: 10.1016/s0360-3016(01)01579-6.'}, {'pmid': '11240234', 'type': 'BACKGROUND', 'citation': 'Lawton CA, Winter K, Murray K, Machtay M, Mesic JB, Hanks GE, Coughlin CT, Pilepich MV. Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):937-46. doi: 10.1016/s0360-3016(00)01516-9.'}, {'pmid': '9598512', 'type': 'BACKGROUND', 'citation': 'Granfors T, Modig H, Damber JE, Tomic R. Combined orchiectomy and external radiotherapy versus radiotherapy alone for nonmetastatic prostate cancer with or without pelvic lymph node involvement: a prospective randomized study. J Urol. 1998 Jun;159(6):2030-4. doi: 10.1016/S0022-5347(01)63235-X.'}, {'pmid': '3133327', 'type': 'BACKGROUND', 'citation': 'Zagars GK, Johnson DE, von Eschenbach AC, Hussey DH. Adjuvant estrogen following radiation therapy for stage C adenocarcinoma of the prostate: long-term results of a prospective randomized study. Int J Radiat Oncol Biol Phys. 1988 Jun;14(6):1085-91. doi: 10.1016/0360-3016(88)90383-5.'}, {'pmid': '15817329', 'type': 'BACKGROUND', 'citation': 'Pilepich MV, Winter K, Lawton CA, Krisch RE, Wolkov HB, Movsas B, Hug EB, Asbell SO, Grignon D. Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1285-90. doi: 10.1016/j.ijrobp.2004.08.047.'}, {'pmid': '12902891', 'type': 'BACKGROUND', 'citation': 'Jani AB, Basu A, Abdalla I, Connell PP, Krauz L, Vijayakumar S. Impact of hormone therapy when combined with external beam radiotherapy for early-stage, intermediate-, or high-risk prostate cancer. Am J Clin Oncol. 2003 Aug;26(4):382-5. doi: 10.1097/01.COC.0000026483.80660.94.'}, {'pmid': '12957248', 'type': 'BACKGROUND', 'citation': 'Nguyen KH, Horwitz EM, Hanlon AL, Uzzo RG, Pollack A. Does short-term androgen deprivation substitute for radiation dose in the treatment of high-risk prostate cancer? Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):377-83. doi: 10.1016/s0360-3016(03)00573-x.'}, {'pmid': '16170164', 'type': 'RESULT', 'citation': 'Zapatero A, Valcarcel F, Calvo FA, Algas R, Bejar A, Maldonado J, Villa S. Risk-adapted androgen deprivation and escalated three-dimensional conformal radiotherapy for prostate cancer: Does radiation dose influence outcome of patients treated with adjuvant androgen deprivation? A GICOR study. J Clin Oncol. 2005 Sep 20;23(27):6561-8. doi: 10.1200/JCO.2005.09.662.'}, {'pmid': '35427469', 'type': 'DERIVED', 'citation': 'Zapatero A, Guerrero A, Maldonado X, Alvarez A, San-Segundo CG, Rodriguez MAC, Sole JM, Olive AP, Casas F, Boladeras A, de Vidales CM, de la Torre MLV, Vara S, Sanz JL, Calvo FA. High-dose radiotherapy and risk-adapted androgen deprivation in localised prostate cancer (DART 01/05): 10-year results of a phase 3 randomised, controlled trial. Lancet Oncol. 2022 May;23(5):671-681. doi: 10.1016/S1470-2045(22)00190-5. Epub 2022 Apr 12.'}, {'pmid': '27598804', 'type': 'DERIVED', 'citation': 'Zapatero A, Guerrero A, Maldonado X, Alvarez A, Gonzalez-San Segundo C, Cabeza Rodriguez MA, Macias V, Pedro Olive A, Casas F, Boladeras A, Martin de Vidales C, Vazquez de la Torre ML, Calvo FA. Late Radiation and Cardiovascular Adverse Effects After Androgen Deprivation and High-Dose Radiation Therapy in Prostate Cancer: Results From the DART 01/05 Randomized Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):341-348. doi: 10.1016/j.ijrobp.2016.06.2445. Epub 2016 Jun 22.'}, {'pmid': '25702876', 'type': 'DERIVED', 'citation': 'Zapatero A, Guerrero A, Maldonado X, Alvarez A, Gonzalez San Segundo C, Cabeza Rodriguez MA, Macias V, Pedro Olive A, Casas F, Boladeras A, de Vidales CM, Vazquez de la Torre ML, Villa S, Perez de la Haza A, Calvo FA. High-dose radiotherapy with short-term or long-term androgen deprivation in localised prostate cancer (DART01/05 GICOR): a randomised, controlled, phase 3 trial. Lancet Oncol. 2015 Mar;16(3):320-7. doi: 10.1016/S1470-2045(15)70045-8. Epub 2015 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'The present study is a phase III randomized and multicentric trial evaluating the potential additional impact effect of two years adjuvant androgen deprivation when combined with neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk prostate cancer patients. Stratification will be performed by prognostic factors and by participating institution.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological proven adenocarcinoma of the prostate\n* Stage: cT1c-3b N0M0 according to American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM)\n* Prostatic Specific Antigen (PSA)\\<100 ng/ml\n* Intermediate (T1-T2 with Gleason Score \\[GS\\] 7 and/or PSA 10-20)\n* High risk (T3 and/or GS 8-10 and/or PSA \\> 20)\n* Karnofsky Index (KI) performance status ≥70%\n* Written informed consent\n\nExclusion Criteria:\n\n* T4 N1 M1,\n* Previous surgical treatment (prostatectomy or cryosurgery)\n* Neoadjuvant hormonal treatment \\> 3 months.\n* History of pelvic radiotherapy (RT)\n* Contraindications for radiotherapy\n* Concomitant use of chemotherapy\n* Serious psychiatric or medical condition\n* Current synchronic malignancies'}, 'identificationModule': {'nctId': 'NCT02175212', 'acronym': 'AADLPC', 'briefTitle': 'Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa'}, 'officialTitle': 'Phase III Multicenter Randomized Trial of Adjuvant Androgen Deprivation in Combination With Three-dimensional Conformal Radiotherapy Doses in High and Intermediate Risk Localized Prostate Cancer.', 'orgStudyIdInfo': {'id': 'DART01/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long term androgen deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy', 'interventionNames': ['Drug: Long term androgen deprivation', 'Radiation: Long term androgen deprivation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Short term androgen deprivation', 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* High dose conformal radiotherapy', 'interventionNames': ['Drug: Short term androgen deprivation', 'Radiation: Short term androgen deprivation']}], 'interventions': [{'name': 'Short term androgen deprivation', 'type': 'DRUG', 'otherNames': ['Neoadjuvant and concomitant'], 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months', 'armGroupLabels': ['Short term androgen deprivation']}, {'name': 'Long term androgen deprivation', 'type': 'DRUG', 'otherNames': ['Neoadjuvant, concomitant and adjuvant'], 'description': '* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)\n* Bicalutamide 50 mg tablet every day for 2 months\n* Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy', 'armGroupLabels': ['Long term androgen deprivation']}, {'name': 'Short term androgen deprivation', 'type': 'RADIATION', 'description': 'Minimum dose of 76 Gy (range 76-82 Gy)', 'armGroupLabels': ['Short term androgen deprivation']}, {'name': 'Long term androgen deprivation', 'type': 'RADIATION', 'description': 'Minimum dose of 76 Gy (range 76-82 Gy)', 'armGroupLabels': ['Long term androgen deprivation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de la Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Almudena Zapatero, MD PhD, IP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grupo de Investigación Clínica en Oncología Radioterapia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}