Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-30 @ 5:40 AM
Study NCT ID:
NCT01320735
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2011-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Russia']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie (prior sponsor, Abbott)'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From signing of informed consent up to 24 months of observation of treatment period and 30 days of follow up period', 'eventGroups': [{'id': 'EG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa', 'otherNumAtRisk': 283, 'otherNumAffected': 73, 'seriousNumAtRisk': 283, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'DISEASE PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'GYNAECOMASTIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'BREAST ENLARGEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'ACQUIRED HYDROCELE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'ERECTILE DYSFUNCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'PEPTIC ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'GASTRIC ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'DERMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'CARDIAC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'ARTHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'RENAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'RIB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}], 'seriousEvents': [{'term': 'DISEASE PROGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'CARDIAC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'RENAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 17'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of IAD Regimen Induction Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'All participants (N=240)', 'categories': [{'measurements': [{'value': '7.70', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Participants with no progression (N=207)', 'categories': [{'measurements': [{'value': '7.75', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Participants with progression (N=33)', 'categories': [{'measurements': [{'value': '7.32', 'spread': '1.79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At least 6-9 months after Baseline (enrollment)', 'description': 'Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from participants who started IAD.'}, {'type': 'PRIMARY', 'title': 'Mean Duration of Leuprorelin Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'All participants', 'categories': [{'measurements': [{'value': '19.74', 'spread': '6.39', 'groupId': 'OG000'}]}]}, {'title': 'Participants with no progression (N=227)', 'categories': [{'measurements': [{'value': '21.25', 'spread': '5.31', 'groupId': 'OG000'}]}]}, {'title': 'Participants with progression (N=56)', 'categories': [{'measurements': [{'value': '13.62', 'spread': '6.79', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.'}, {'type': 'PRIMARY', 'title': 'Mean Duration of Each Leuprorelin Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'All Participants: Cycle 1 (N=282)', 'categories': [{'measurements': [{'value': '7.63', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'All Participants: Cycle 2 (N=238)', 'categories': [{'measurements': [{'value': '5.60', 'spread': '2.21', 'groupId': 'OG000'}]}]}, {'title': 'All Participants: Cycle 3 (N=61)', 'categories': [{'measurements': [{'value': '4.64', 'spread': '1.63', 'groupId': 'OG000'}]}]}, {'title': 'All Participants: Cycle 4 (N=7)', 'categories': [{'measurements': [{'value': '3.44', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'All Participants: Cycle 5 (N=1)', 'categories': [{'measurements': [{'value': '3.30', 'spread': 'NA', 'comment': 'Not applicable as only 1 participant was assessed.', 'groupId': 'OG000'}]}]}, {'title': 'Participants with No Progression: Cycle 1 (N=226)', 'categories': [{'measurements': [{'value': '7.68', 'spread': '1.49', 'groupId': 'OG000'}]}]}, {'title': 'Participants with No Progression: Cycle 2 (206)', 'categories': [{'measurements': [{'value': '5.70', 'spread': '2.08', 'groupId': 'OG000'}]}]}, {'title': 'Participants with No Progression: Cycle 3 (N=52)', 'categories': [{'measurements': [{'value': '4.72', 'spread': '1.55', 'groupId': 'OG000'}]}]}, {'title': 'Participants with No Progression: Cycle 4 (N=7)', 'categories': [{'measurements': [{'value': '3.44', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Participants with No Progression: Cycle 5 (N=1)', 'categories': [{'measurements': [{'value': '3.30', 'spread': 'NA', 'comment': 'Not applicable as only 1 participant was assessed.', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Progression: Cycle 1 (N=56)', 'categories': [{'measurements': [{'value': '7.43', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Progression: Cycle 2 (N=32)', 'categories': [{'measurements': [{'value': '4.96', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': 'Participants with Progression: Cycle 3 (N=9)', 'categories': [{'measurements': [{'value': '4.19', 'spread': '2.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 months', 'description': 'Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'All Participants', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Participants who started IAD', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Participants who did not start IAD', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.'}, {'type': 'PRIMARY', 'title': 'Median Number of Leuprorelin Cycles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 months', 'description': 'The Participants were on IAD regimen and the data are reported as number of cycles with full range.', 'unitOfMeasure': 'Cycles', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. However, one participant started continuous hormone therapy and was not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Median Time to Progression of HRPC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'All Participants (N=36)', 'categories': [{'measurements': [{'value': '17.12', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '24.80'}]}]}, {'title': 'Participants who started IAD (N=28)', 'categories': [{'measurements': [{'value': '19.10', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '24.80'}]}]}, {'title': 'Participants who did not start IAD (N=8)', 'categories': [{'measurements': [{'value': '8.11', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '15.40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit.'}, {'type': 'SECONDARY', 'title': 'Median Time to Progression of HRPC in Participants Not Started on IAD Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '15.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements of participants who did not start on IAD regimen.'}, {'type': 'SECONDARY', 'title': 'Median Survival Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'All Participants (N=4)', 'categories': [{'measurements': [{'value': '18.94', 'groupId': 'OG000', 'lowerLimit': '11.80', 'upperLimit': '24.80'}]}]}, {'title': 'Participants who started IAD (N=2)', 'categories': [{'measurements': [{'value': '24.44', 'groupId': 'OG000', 'lowerLimit': '24.10', 'upperLimit': '24.80'}]}]}, {'title': 'Participants who did not start IAD (N=2)', 'categories': [{'measurements': [{'value': '12.76', 'groupId': 'OG000', 'lowerLimit': '11.80', 'upperLimit': '13.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who died while on study were used for analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Received IAD Regimen During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'All participants', 'categories': [{'measurements': [{'value': '243', 'groupId': 'OG000'}]}]}, {'title': 'Participants with no progression', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}]}]}, {'title': 'Participants with progression', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'The data are reported as number of participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from participants who started IAD.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'All participants', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Participants with no progression (N=210)', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Participants with progression (N=33)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'The data are reported as number of participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from participants who started IAD.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'Overall Study', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 (N=240)', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 (N=119)', 'categories': [{'measurements': [{'value': '62.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 (N=17)', 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 (N=1)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'The data are reported as percentage of participants.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.'}, {'type': 'SECONDARY', 'title': 'Mean Duration of Treatment-off Time in IAD Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'categories': [{'measurements': [{'value': '7.12', 'spread': '2.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin \\[cycle N+1\\] minus last dose date \\[cycle N\\] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from participants who started IAD.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Switched to IAD Regimen by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'title': 'Visit 2 After One Year (N=257)', 'categories': [{'measurements': [{'value': '237', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3 After Two Years (N=225)', 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'The data are reported as number of participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin.'}, {'type': 'SECONDARY', 'title': 'Median Percentage of Time Off-treatment During 2 Years IAD Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'classes': [{'categories': [{'measurements': [{'value': '33.45', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '67.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.', 'unitOfMeasure': 'Percentage of time off-treatment', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are of measurements collected from participants who started IAD.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Advanced Prostate Cancer (PCa)', 'description': 'Participants with advanced PCa'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Administrative Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Progression/Hormone-Refractory Pca', 'reasons': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No Decrease of Prostate Specific Antigen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Investigator Unable to be Contacted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}]}], 'preAssignmentDetails': 'From 300 participants enrolled in the study, data of 17 participants from one of the sites were excluded from analysis because of the impossibility to contact the investigator for data clarification. Hence 283 participants were included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Advanced PCa', 'description': 'Participants with advanced PCa'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'spread': '6.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '283', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of Leuprorelin.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2011-02-14', 'resultsFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-11', 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of IAD Regimen Induction Phase', 'timeFrame': 'At least 6-9 months after Baseline (enrollment)', 'description': 'Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.'}, {'measure': 'Number of Participants Who Received IAD Regimen During the Study', 'timeFrame': '24 months', 'description': 'The data are reported as number of participants.'}, {'measure': 'Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study', 'timeFrame': '24 months', 'description': 'The data are reported as number of participants.'}], 'primaryOutcomes': [{'measure': 'Mean Duration of Leuprorelin Exposure', 'timeFrame': '24 months', 'description': 'Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.'}, {'measure': 'Mean Duration of Each Leuprorelin Cycle', 'timeFrame': '24 months', 'description': 'Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.'}, {'measure': 'Median Number of Leuprorelin Cycles', 'timeFrame': '24 months', 'description': 'The Participants were on IAD regimen and the data are reported as number of cycles with full range.'}, {'measure': 'Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen', 'timeFrame': '24 months', 'description': 'The data are reported as percentage of participants.'}, {'measure': 'Number of Participants Who Switched to IAD Regimen by Visit', 'timeFrame': '24 months', 'description': 'The data are reported as number of participants.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.'}, {'measure': 'Median Time to Progression of HRPC', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).'}, {'measure': 'Median Time to Progression of HRPC in Participants Not Started on IAD Regimen', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.'}, {'measure': 'Median Survival Time', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.'}, {'measure': 'Mean Duration of Treatment-off Time in IAD Regimen', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin \\[cycle N+1\\] minus last dose date \\[cycle N\\] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.'}, {'measure': 'Median Percentage of Time Off-treatment During 2 Years IAD Regimen', 'timeFrame': 'Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit', 'description': 'The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lucrin Depot', 'intermittent adjuvant regimen', 'advanced prostate cancer', 'Leuprorelin'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)', 'detailedDescription': 'Participants started hormone treatment with Leuprorelin 3.75 mg once every 28 days, subcutaneously (SC) or intramuscularly (IM). Duration of induction therapy was at least 6 months (6-9 months) during which PSA and testosterone levels were measured every 3 months. When PSA decreased by greater than 90% from baseline (PSA less than 10 ng/ml) or became lower than 4.0 ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the participants were included into intermittent hormone therapy regimen group (IAD). Participants with PSA decrease not achieved greater than 90% or less than or equal to 4.0 ng/ml were given either continuous hormone therapy (CAD) or chemotherapy.\n\nTherapy was stopped if participants had PSA decrease greater than 90% from baseline or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy. PSA and testosterone were measured every 4 weeks. If PSA became greater than or equal to 10.0 ng/ml, hormone therapy was resumed until PSA was less than 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. Duration of hormonal therapy cycle was at least 3 months. Then intermittent treatment was performed according to a similar scheme. PSA and testosterone levels were determined every 12 weeks when hormone therapy was administered and every 4 weeks after it was stopped. The treatment was carried out for 2 years or until Hormone Refractory Prostate Cancer (HRPC) developed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with advanced PCa', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically confirmed advanced PCa meeting the following criteria:\n\n 1. Any Tumor, Node 1, Metastasis 0\n 2. Any Tumor, Node 0, Metastasis 1 \\[according to Tumor Node Metastasis classification 2009\\]\n2. Participants planned for administration of leuprorelin\n3. World Health Organization status 0-1\n4. Life expectancy at least 2 years\n\nExclusion Criteria:\n\n1. Contraindications to administration of leuprorelin:\n\n 1. Hypersensitivity to Leuprorelin similar products of protein origin or any of the excipients in drug product composition\n 2. Surgical castration\n2. Hormone-refractory PCa\n3. Presence of another malignant tumor (except skin cancer)\n4. Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens\n5. Previous administration of radiotherapy or chemotherapy course within 1 month\n6. Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion\n7. Extremely high level of PSA (greater than or equal to 1000 ng/ml)\n8. Other severe diseases in stage of decompensation\n9. Other contraindications, that make the participant's participation impossible (by investigator judgment)\n10. Previous enrollment in the present program"}, 'identificationModule': {'nctId': 'NCT01320735', 'briefTitle': 'Observational Program to Assess Use of Intermittent Adjuvant Deprivation Therapy With Leuprorelin (Lucrin Depot) in Patients With Advanced Prostate Cancer (PCa) in Russia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Prospective, Multi-Center, Observational Program to Assess Routine Use of Intermittent Adjuvant Deprivation Therapy With Lucrin Depot in Patients With Advanced Prostate Cancer in the Russian Federation', 'orgStudyIdInfo': {'id': 'P12-763'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced PCa', 'description': 'Participants with advanced PCa'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Andrey Strugovshchikov, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Almedis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}