Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT00937768
Status:
TERMINATED
Last Update Posted:
2019-12-27
First Post:
2009-07-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'C493311', 'term': 'luprolide acetate gel depot'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Karnes.R@mayo.edu', 'phone': '507 284-4430', 'title': 'Dr. R. Jeffrey Karnes', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 17, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Taste alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 26, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 16, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 31, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 15, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Gynecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 21, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}], 'seriousEvents': [{'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Biochemical Progression-free Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'OG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'timeFrame': '2 years', 'description': 'Biochemical progression-free survival (BPFS) was defined as the time from randomization to the time of biochemical progression. If a patient dies without a documentation of biochemical progression, the patient will be considered to have had progressed at the time of death.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants reached the 2 years follow up due to the early termination of the trial.'}, {'type': 'SECONDARY', 'title': 'Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'OG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'The number of deaths due to any cause are reported below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely due to funding issues. Planned analysis for Overall Survival and Prostate Cancer Specific Survival was not performed due to the nature of the closure. Thus, the number of deaths are reported below.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Grade 3 or Higher Adverse Events Regardless of Attribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'OG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Percentage of Participants with Grade 3 or Higher Adverse Events regardless of attribution per NCI CTCAE Version 3', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Overall FACT-P Total Score at Baseline, Months 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'OG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.7', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '114.8', 'spread': '16.92', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.6', 'spread': '19.11', 'groupId': 'OG000'}, {'value': '117.8', 'spread': '18.67', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '109.4', 'spread': '23.83', 'groupId': 'OG000'}, {'value': '136.8', 'spread': '3.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and months 3 and 6', 'description': 'The overall FACT-P Total Score at Baseline and months 3 and 6 mean and standard deviations are reported below. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the FACT-P and had FACT-P Total Score data at each of the time points are included in each analysis at each time point below.'}, {'type': 'SECONDARY', 'title': 'Average LASA Overall Quality of Life at Baseline, Months 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'OG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Months 3 and 6', 'description': 'LASA Overall Quality of Life at Baseline, Months 3 and 6. Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The average and standard deviation of the LASA overall quality of life score are reported below at baseline, months 3 and 6.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who completed the LASA and had LASA Overall Quality of Life data at each of the time points are included in each analysis at each time point below.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'OG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'timeFrame': '2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'OG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'timeFrame': '2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'OG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'timeFrame': '2 years', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated prematurely due to funding issues. Planned analysis was not performed due to the nature of the closure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'FG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Refused Further Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Alternate Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No Further Funding', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Sixteen (16) participants were recruited at Mayo Clinic (Rochester) between July 2009 and June 2012.', 'preAssignmentDetails': 'This trial was terminated early due to funding issues.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Androgen Deprivation Therapy', 'description': 'Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.'}, {'id': 'BG001', 'title': 'No Androgen Deprivation Therapy', 'description': 'Patients undergo observation every 3 months for 9 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '62.0', 'spread': '7.8', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2009-07-09', 'resultsFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2009-07-10', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-08', 'studyFirstPostDateStruct': {'date': '2009-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate', 'timeFrame': '2 years'}, {'measure': 'Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs)', 'timeFrame': '2 years'}, {'measure': 'Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms', 'timeFrame': '2 years'}], 'primaryOutcomes': [{'measure': 'Biochemical Progression-free Survival Rate', 'timeFrame': '2 years', 'description': 'Biochemical progression-free survival (BPFS) was defined as the time from randomization to the time of biochemical progression. If a patient dies without a documentation of biochemical progression, the patient will be considered to have had progressed at the time of death.'}], 'secondaryOutcomes': [{'measure': 'Number of Deaths', 'timeFrame': '2 years', 'description': 'The number of deaths due to any cause are reported below.'}, {'measure': 'Percentage of Participants With Grade 3 or Higher Adverse Events Regardless of Attribution', 'timeFrame': '2 years', 'description': 'Percentage of Participants with Grade 3 or Higher Adverse Events regardless of attribution per NCI CTCAE Version 3'}, {'measure': 'Average Overall FACT-P Total Score at Baseline, Months 3 and 6', 'timeFrame': 'Baseline and months 3 and 6', 'description': 'The overall FACT-P Total Score at Baseline and months 3 and 6 mean and standard deviations are reported below. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.'}, {'measure': 'Average LASA Overall Quality of Life at Baseline, Months 3 and 6', 'timeFrame': 'Baseline to Months 3 and 6', 'description': 'LASA Overall Quality of Life at Baseline, Months 3 and 6. Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The average and standard deviation of the LASA overall quality of life score are reported below at baseline, months 3 and 6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma', 'Stage IIA Prostate Cancer', 'Stage IIB Prostate Cancer', 'Stage III Prostate Cancer', 'Stage IV Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies the side effects and how well giving leuprolide acetate or goserelin acetate works compared to observation in treating patients with high-risk prostate cancer who have undergone radical prostatectomy. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin acetate and leuprolide acetate, may lessen the amount of androgens made by the body and thus control prostate cancer growth. Many times, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. However, in some prostate cancers there is a chance that tumors can re-grow despite surgery based on certain high risk features.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare the difference in the biochemical progression-free survival rate (bPFS) at 2-years between immediate androgen deprivation therapy (ADT) for nine months in high risk prostate cancer patients following radical prostatectomy and a similar high risk patient population followed without initiation of immediate ADT treatment.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the difference in bPFS, prostate cancer specific survival, and overall survival between immediate ADT for nine months and observation for high risk prostate cancer patients following radical prostatectomy.\n\nII. To evaluate the toxicity profile and quality of life (QOL) measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) and linear analogue self assessment (LASA) between two treatment arms.\n\nTERTIARY OBJECTIVES:\n\nI. To explore if serum and urine biomarker(s) levels at study entry, 9 months, or 24 months in the two treatment arms are correlated with biochemical progression-free survival rate.\n\nII. To explore if \\> 5 circulating tumor cells (CTCs) or circulating endothelial cells (CECs) following study treatments are associated with biochemical progression-free survival rate.\n\nIII. To explore the prognostic and predictive value of tissue based biomarkers in high risk prostate cancer patients.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\nARM A: Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1. Courses repeat every 3 months for 9 months in the absence of disease progression or unacceptable toxicity.\n\nARM B: Patients undergo observation every 3 months for 9 months.\n\nAfter completion of study treatment, patients are followed up every three months for 2 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PRE-REGISTRATION:\n* Informed consent explained and signed prior to any study related procedures\n* Patients with any one of the following "high risk" criteria:\n\n * Clinical or pathological Gleason score 8-10\n * Prostate-specific antigen (PSA) \\> 20 ng/ml at initial presentation prior to radical prostatectomy\n* Willingness to provide mandatory tissue for research purposes\n* Willingness to provide mandatory blood for research purposes\n* Has no history of androgen deprivation therapy within the past 6 months or has been treated neoadjuvantly up to 6 months prior to radical prostatectomy with the following agents; luteinizing hormone-releasing hormone (LHRH) agonists, anti-androgens, 5 alpha-reductase inhibitors, and peripheral anti-androgens\n* REGISTRATION:\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; or Karnofsky performance of \\> 60%\n* Patients with any one of the following "high risk" criteria:\n\n * Gleason, prostate specific antigen, seminal vesicle and margin status (GPSM) score \\>= 10 \\[GS + 1\\*(PSA 4-10)+2\\*(PSA 10.1-20)+3\\*(PSA \\> 20)+2\\*(seminal vesicular or nodal involvement) +2\\*(margin)\\](determined post radical prostatectomy)\n * Post prostatectomy seminal vesicle invasion (pT3b) or pT4\n * Two or less microscopic lymph nodal metastasis determined at the time of prostatectomy OR\n * Gleason 4+3 at the time of prostatectomy with margin positivity\n* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =\\< 2 x institutional upper limit of normal (ULN)\n* Total bilirubin =\\< 2 x institutional ULN\n* For patients identified as high-risk on the basis of pathological criteria after undergoing radical prostatectomy: interval time for study enrollment after radical prostatectomy will be =\\< 28 days of the prostatectomy\n* For patients identified as high-risk prior to undergoing radical prostatectomy: patients presenting with a high Gleason score (8-10) and/or a PSA \\> 20 ng/ml are deemed eligible for study participation and study registration as long as the eligibility criteria is reconfirmed post radical prostatectomy; these patient groups may choose to register prior to or after prostatectomy\n* Study randomization must occur =\\< 28 days of radical prostatectomy; all patients consented on the trial, whether consented in the pre-prostatectomy or post-prostatectomy period, will be randomized to study treatments =\\< 28 days of prostatectomy\n* Ability to complete questionnaire(s) by themselves or with assistance\n\nExclusion Criteria:\n\n* PRE-REGISTRATION\n* Transitional cell, small cell, or squamous cell carcinoma of the prostate; NOTE: patients consented for participation prior to prostatectomy, if detected to have above listed histo-pathologies after prostatectomy will be deemed ineligible and not proceed to study randomization\n* History of primary prostate cancer treatment\n* Evidence of clinical nodal disease (N1) or grossly evident metastasis at the time of enrollment\n* History of bilateral orchiectomy; unilateral orchiectomy with normal range serum testosterone levels will be allowed for enrollment\n* Evidence of metastasis on radiographic metastatic workup within a preceding period of 4 months from the time of study entry, including whole body radionuclide bone scan, computed tomography (CT) and/or magnetic resonance (MR) scan of the pelvis and abdomen; otherwise will perform at the time of the baseline tests and result must be normal to continue on study; results of ProstaScint or other radionuclide scans, excluding radionuclide bone scans, will NOT be used to establish metastatic disease if all other studies are negative\n* Receiving other experimental drugs =\\< 4 weeks prior to consenting\n* Uncontrolled infection\n* History of other cancer, excluding squamous cell and basal cell skin cancers, within the preceding 2 years\n* Documented history of human immunodeficiency virus (HIV) positivity or other acquired immunodeficiency disorder, congenital immunodeficiency disorder, or history of organ transplantation\n* Unable to follow up every three months for the first year to Mayo Clinic, Rochester for receiving LHRH analogues or study monitoring\n* REGISTRATION:\n* Uncontrolled infection\n* Unable to follow up every three months for the first year to Mayo Clinic, Rochester for receiving LHRH analogues or study monitoring'}, 'identificationModule': {'nctId': 'NCT00937768', 'briefTitle': 'Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Phase II Trial of Temporary Androgen Deprivation Therapy in High Risk Prostate Cancer Following Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'MC0852'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01147', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '08-001519'}, {'id': 'MC0852', 'type': 'OTHER', 'domain': 'Mayo Clinic'}, {'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (antihormone therapy)', 'description': 'Patients receive leuprolide acetate IM on day 1 OR goserelin acetate SC on day 1. Courses repeat every 3 months for 9 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Goserelin Acetate', 'Other: Laboratory Biomarker Analysis', 'Drug: Leuprolide Acetate', 'Other: Quality-of-Life Assessment']}, {'type': 'NO_INTERVENTION', 'label': 'Arm B (no antihormone therapy)', 'description': 'Patients undergo observation every 3 months for 9 months.'}], 'interventions': [{'name': 'Goserelin Acetate', 'type': 'DRUG', 'otherNames': ['ZDX', 'Zoladex'], 'description': 'Given SC', 'armGroupLabels': ['Arm A (antihormone therapy)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm A (antihormone therapy)']}, {'name': 'Leuprolide Acetate', 'type': 'DRUG', 'otherNames': ['A-43818', 'Abbott 43818', 'Abbott-43818', 'Carcinil', 'Depo-Eligard', 'Eligard', 'Enanton', 'Enantone', 'Enantone-Gyn', 'Ginecrin', 'LEUP', 'Leuplin', 'Leuprorelin Acetate', 'Lucrin', 'Lucrin Depot', 'Lupron', 'Lupron Depot', 'Lupron Depot-3 Month', 'Lupron Depot-4 Month', 'Lupron Depot-Ped', 'Procren', 'Procrin', 'Prostap', 'TAP-144', 'Trenantone', 'Uno-Enantone', 'Viadur'], 'description': 'Given IM', 'armGroupLabels': ['Arm A (antihormone therapy)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm A (antihormone therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Robert Karnes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}