Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01220869
Status:
COMPLETED
Last Update Posted:
2025-04-13
First Post:
2010-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Degarelix in Taiwanese Patients With Prostate Cancer
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': 'C431566', 'term': 'acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from signed informed consent until the end-of-trial visit, 168 days.', 'description': 'Adverse events were evaluated at each visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Degarelix', 'description': 'Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).', 'otherNumAtRisk': 110, 'otherNumAffected': 69, 'seriousNumAtRisk': 110, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 92, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 75, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 78, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Leukaemoid reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Carcinoembryonic antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chest wall mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bladder obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Focal segmental glomerulosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix', 'description': 'Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '99.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 28 to Day 168', 'description': "Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix', 'description': 'Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '87.1', 'upperLimit': '97.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Proportion of participants with testosterone at castrate level (\\<= 0.5 ng/mL) at Day 3', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix', 'description': 'Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '-92.4', 'groupId': 'OG000', 'lowerLimit': '-96.0', 'upperLimit': '-83.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 0 to Day 28', 'description': 'Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28', 'unitOfMeasure': 'Percentage change of PSA', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix', 'description': 'Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '99.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 28 to Day 168', 'description': "Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP analysis set included all participants from the FAS analysis set without major protocol violations.'}, {'type': 'SECONDARY', 'title': 'Cumulative Probability of no PSA Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Degarelix', 'description': 'Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}]}]}, {'title': 'Day 0 to <= Day 7', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}]}]}, {'title': 'Day 0 to <= Day 28', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}]}]}, {'title': 'Day 0 to <= Day 112', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '99.9'}]}]}, {'title': 'Day 0 to <= Day 140', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '99.5'}]}]}, {'title': 'Day 0 to <= Day 168', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '90.1', 'upperLimit': '98.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168', 'description': 'The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The data of all participants who received at least one dose of degarelix and had at least one efficacy assessment after dosing comprised the FAS dataset.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Degarelix', 'description': 'Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The participants were recruited among the patients attending the clinics included in the trial', 'preAssignmentDetails': '125 participants were screened and 110 participants were enrolled and exposed to degarelix.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Degarelix', 'description': 'Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '8.3', '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': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The number of baseline participants is identical to the number of patients exposed to degarelix.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2010-10-13', 'resultsFirstSubmitDate': '2013-10-14', 'studyFirstSubmitQcDate': '2010-10-13', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-14', 'studyFirstPostDateStruct': {'date': '2010-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168 - Sensitivity Analysis', 'timeFrame': 'From Day 28 to Day 168', 'description': "Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% CI was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The FAS analysis results were considered primary, whereas the corresponding PP analysis served as the sensitivity analysis."}], 'primaryOutcomes': [{'measure': 'Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168', 'timeFrame': 'From Day 28 to Day 168', 'description': "Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis."}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Testosterone at Castrate Level (<= 0.5 ng/mL) at Day 3', 'timeFrame': 'Day 3', 'description': 'Proportion of participants with testosterone at castrate level (\\<= 0.5 ng/mL) at Day 3'}, {'measure': 'Percentage Change in Serum Prostate Specific Antigen (PSA) Levels From Baseline (Day 0) to Day 28', 'timeFrame': 'From Day 0 to Day 28', 'description': 'Percentage change in serum prostate specific antigen (PSA levels from Baseline (Day 0) to Day 28'}, {'measure': 'Cumulative Probability of no PSA Failure', 'timeFrame': 'Day 0, Day 7, Day 28, Day 112, Day 140, Daý 168', 'description': 'The time to PSA failure was defined as the days from first dosing (scheduled trial days) where an increase in serum PSA of ≥50% from nadir and at least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted. The second occasion was the time point of meeting the criterion. The Kaplan-Meier estimate and associated 95% CI were provided.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years or older\n* Has a histological confirmed prostate cancer\n* Has a screening serum testosterone above 1.5 ng/mL\n* Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2\n* Has a screening PSA value of ≥2 ng/mL\n* Has a life expectancy of at least 168 days\n\nExclusion Criteria:\n\n* Current or previous hormone therapy\n* Is currently treated with 5-α-reductase inhibitor\n* Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema\n* Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy\n* Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.\n* Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator\n* Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial'}, 'identificationModule': {'nctId': 'NCT01220869', 'briefTitle': 'A Study of Degarelix in Taiwanese Patients With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy', 'orgStudyIdInfo': {'id': 'FE200486 CS43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degarelix', 'interventionNames': ['Drug: Degarelix']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['degarelix acetate', 'Firmagon', 'FE200486'], 'description': 'Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).', 'armGroupLabels': ['Degarelix']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'Chang Gung Medical Foundation, Chiayi Branch', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital, Kaohsiung', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Chi-Mei Foundation Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital, Linkuo', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}