Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-31 @ 10:14 PM
Study NCT ID:
NCT02737332
Status:
COMPLETED
Last Update Posted:
2021-11-22
First Post:
2016-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant 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': 'D000069501', 'term': 'Abiraterone Acetate'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@sparcmail.com', 'phone': '912266455645', 'title': 'Head, Clinical Development', 'organization': 'SPARC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the time of signing of the ICF until study completion (84 Days). The AEs collected in the source documents for screening failures did not need to be entered into eCRF, however once a potential patient was randomized, all AEs were to be entered into the eCRF.', 'description': 'The investigator monitored and/or asked about or evaluated AEs using non-leading questions at each visit or evaluation.', 'eventGroups': [{'id': 'EG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': '1,000 MG (4 x 250 mg qd)\n\nZytiga® (Abiraterone Acetate): Zytiga® 1,000 mg (4 x 250 mg qd) Compared to SoluMatrix™ Abiraterone Acetate 500 mg', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 22, 'seriousNumAtRisk': 29, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': '500 mg (4 x 125 mg qd)\n\nSoluMatrix™ (Abiraterone Acetate): SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 16, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatiineincreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophgeal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Corornary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Progression of prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of left hydroureteronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Testosterone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4879', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio of treatments', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.019', 'ciLowerLimit': '0.964', 'ciUpperLimit': '1.077', 'pValueComment': 'One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.', 'estimateComment': 'Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.'}], 'paramType': 'MEAN', 'timeFrame': 'Average of Day 9 and 10', 'description': 'Blood Sample tested for Serum Testosterone Levels', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of serum T levels in the ITT population'}, {'type': 'SECONDARY', 'title': 'PSA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'classes': [{'title': 'Day 28', 'categories': [{'measurements': [{'value': '37.5', 'spread': '11.33', 'groupId': 'OG000'}, {'value': '22.37', 'spread': '12.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '40.84', 'spread': '12.58', 'groupId': 'OG000'}, {'value': '25.29', 'spread': '13.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 84', 'categories': [{'measurements': [{'value': '33.88', 'spread': '13.43', 'groupId': 'OG000'}, {'value': '26.46', 'spread': '15.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.994', 'ciLowerLimit': '0.0451', 'ciUpperLimit': '2.192', 'pValueComment': 'One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.', 'estimateComment': 'Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.'}, {'pValue': '0.4069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.810', 'ciLowerLimit': '0.338', 'ciUpperLimit': '1.939', 'pValueComment': 'One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.', 'estimateComment': 'Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.'}, {'pValue': '0.7186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.039', 'ciLowerLimit': '0.412', 'ciUpperLimit': '2.617', 'pValueComment': 'The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.', 'estimateComment': 'Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 28, Day 56, and Day 84', 'description': 'All patients randomized to one of the two treatment groups, round about level of PSA.\n\nThese were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population:The intention-to-treat (ITT) population is defined as all subjects who are randomized to one of the two treatment groups. The ITT population is the primary population for PD evaluation. The ITT population will be identified and finalized before the database is locked.'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects With PSA-50 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'classes': [{'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.4', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000'}, {'value': '63.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}, {'value': '68.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28, Day 56, and Day 84', 'description': 'Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences.\n\nThese were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.', 'unitOfMeasure': 'percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population:The intention-to-treat (ITT) population is defined as all subjects who are randomized to one of the two treatment groups. The ITT population is the primary population for PD evaluation. The ITT population will be identified and finalized before the database is locked.'}, {'type': 'SECONDARY', 'title': 'Serum Testosterone Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'classes': [{'title': 'Day 28', 'categories': [{'measurements': [{'value': '1.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '1.01', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Day 84', 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}, {'value': '1', 'spread': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9211', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.999', 'ciLowerLimit': '0.980', 'ciUpperLimit': '1.018', 'pValueComment': 'One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.', 'estimateComment': 'Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.', 'otherAnalysisDescription': 'ANOVA-model-based Least-Square Mean'}, {'pValue': '0.3037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.168', 'ciLowerLimit': '0.900', 'ciUpperLimit': '1.515', 'pValueComment': 'One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.', 'estimateComment': 'Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.000', 'ciLowerLimit': '1.000', 'ciUpperLimit': '1.000', 'pValueComment': 'One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.', 'estimateComment': 'Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 28, Day 56, and Day 84', 'description': 'These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Steady State Trough Concentration of Arbiraterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'classes': [{'title': 'Day 09', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.938', 'spread': '7.044', 'groupId': 'OG000'}, {'value': '27.259', 'spread': '7.772', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.721', 'spread': '23.104', 'groupId': 'OG000'}, {'value': '18.662', 'spread': '24.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.978', 'spread': '8.117', 'groupId': 'OG000'}, {'value': '18.707', 'spread': '9.175', 'groupId': 'OG001'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.263', 'spread': '3.087', 'groupId': 'OG000'}, {'value': '13.819', 'spread': '3.381', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5495', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2616', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3632', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3393', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 09, Day 28, Day 56, and Day 84', 'description': 'These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'AUC (0-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1020.218', 'spread': '154.549', 'groupId': 'OG000'}, {'value': '326.458', 'spread': '218.565', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '60 to 30 minutes prior to dosing and over 24 Hours post-dose', 'description': 'Steady state systemic exposure parameters', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC (0-24 hr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets.'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '870.859', 'spread': '221.709', 'groupId': 'OG000'}, {'value': '626.066', 'spread': '280.443', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '60 to 30 minutes prior to dosing and over 24 Hours post-dose', 'description': 'Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.'}, {'type': 'SECONDARY', 'title': 'AUC (0-t)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '870.859', 'spread': '221.709', 'groupId': 'OG000'}, {'value': '626.066', 'spread': '280.443', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '60 to 30 minutes prior to dosing and over 24 Hours post-dose', 'description': 'Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.'}, {'type': 'SECONDARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'OG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': '500 mg (4 x 125 mg qd)\n\nSoluMatrix™ (Abiraterone Acetate): SoluMatrix™ Abiraterone Acetate 500 mg Compared to Zytiga® 1,000 mg (4 x 250 mg qd)'}], 'classes': [{'categories': [{'measurements': [{'value': '268.261', 'spread': '69.967', 'groupId': 'OG000'}, {'value': '111.316', 'spread': '88.503', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1917', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '60 to 30 minutes prior to dosing and over 24 Hours post-dose', 'description': 'Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall, 14 subjects were analyzed in the PK population, amongst which, 8 were in the Zytiga group and 5 were in the SoluMatrix group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'FG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zytiga® (Abiraterone Acetate)', 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets'}, {'id': 'BG001', 'title': 'SoluMatrix™ (Abiraterone Acetate)', 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '77', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '75.1', 'spread': '9.3', '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': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-10', 'size': 13036176, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-24T03:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2016-03-25', 'resultsFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2016-04-12', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-27', 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Testosterone Levels', 'timeFrame': 'Average of Day 9 and 10', 'description': 'Blood Sample tested for Serum Testosterone Levels'}], 'secondaryOutcomes': [{'measure': 'PSA Levels', 'timeFrame': 'Day 28, Day 56, and Day 84', 'description': 'All patients randomized to one of the two treatment groups, round about level of PSA.\n\nThese were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint'}, {'measure': 'Percent of Subjects With PSA-50 Response', 'timeFrame': 'Day 28, Day 56, and Day 84', 'description': 'Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences.\n\nThese were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.'}, {'measure': 'Serum Testosterone Levels', 'timeFrame': 'Day 28, Day 56, and Day 84', 'description': 'These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.'}, {'measure': 'Steady State Trough Concentration of Arbiraterone', 'timeFrame': 'Day 09, Day 28, Day 56, and Day 84', 'description': 'These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint.'}, {'measure': 'AUC (0-inf)', 'timeFrame': '60 to 30 minutes prior to dosing and over 24 Hours post-dose', 'description': 'Steady state systemic exposure parameters'}, {'measure': 'AUC (0-24 hr)', 'timeFrame': '60 to 30 minutes prior to dosing and over 24 Hours post-dose', 'description': 'Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).'}, {'measure': 'AUC (0-t)', 'timeFrame': '60 to 30 minutes prior to dosing and over 24 Hours post-dose', 'description': 'Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).'}, {'measure': 'Cmax', 'timeFrame': '60 to 30 minutes prior to dosing and over 24 Hours post-dose', 'description': 'Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the serum testosterone levels in patients with Metastatic Castration-Resistant Prostate Cancer on SoluMatrix™ Abiraterone Acetate as Compared to Abiraterone Acetate', 'detailedDescription': 'This was a 12-week, open-label study of abiraterone acetate in at least 50 patients with metastatic castration-resistant prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent obtained prior to any study-related procedure being performed\n2. Male subjects at least 18 years of age or older at time of consent\n3. Pathologically confirmed adenocarcinoma of the prostate\n4. Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level \\<50 ng/dL at screening\n5. Metastatic disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI) or bone scan. Imaging obtained within 42 days prior to the start of study medication will be accepted.\n6. Meeting disease progression according to the recommendations of the prostate cancer working group 2 by one of the following criteria:\n\n * Two rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL,\n * Imaging progression (CT/MRI) by RECIST criteria\n * Nuclear scan progression by new lesion.\n7. Discontinuation of flutamide or nilutamide, and other anti-androgens at least 4 weeks prior to the start of study medication; discontinuation of bicalutamide at least 6 weeks prior to start of study medication.\n8. Discontinuation of Radiotherapy \\> 4 weeks prior to start of study medication.\n9. ECOG performance status of 0-1 at screening\n10. Screening blood counts of the following:\n\n * Absolute neutrophil count \\> 1500/µL\n * Platelets \\> 100,000/µL\n * Hemoglobin \\> 9 g/dL\n11. Screening chemistry values of the following:\n\n * ALT and AST \\< 2.5 x ULN\n * Total bilirubin \\< 1.5 x ULN\n * Creatinine\\< 1.5 x ULN\n * Albumin \\> 3.0 g/dL\n12. Potassium \\> 3.5 mmol/L\n13. Life expectancy of at least 6 months at screening\n14. Subject is willing and able to comply with all protocol requirements assessments\n15. Agrees to protocol-defined use of effective contraception.\n\nExclusion Criteria:\n\n1. History of impaired pituitary or adrenal gland function\n2. Prior therapy with abiraterone acetate, orteronel, ketoconazole or any other CYP17 inhibitor\n3. Prior therapy with enzalutamide\n4. Prior use of experimental androgen receptor antagonist\n5. Previous exposure to Ra-223:Xofigo\n6. Previous chemotherapy\n7. Initiation of bisphosphonate or denosumab therapy within 30 days prior to the start of study medication. Patients who are on a stable dose of these medications for at least 30 days at the time of starting study drug are eligible.\n8. Therapy with estrogen within 30 days prior to the start of study medication\n9. Use of systemic glucocorticoids equivalent to \\> 10 mg of prednisone daily; patients who have discontinued or have reduced dose to \\< 10 mg prednisone within 14 days prior to the start of study medication will be eligible\n10. Prior use of any herbal products that may decrease PSA levels (eg., saw palmetto) within 30 days of start of study medication\n11. Known metastases to the brain or CNS involvement\n12. History of other malignancy within the previous 2 years\n13. Major surgery within 30 days prior to the start of study medication\n14. Blood transfusion within 30 days of screening\n15. Serious, persistent infection within 14 days of the start of study medication\n16. Persistent pain that requires the use of a narcotic analgesic\n17. Known gastrointestinal disease or condition that may impair absorption\n18. Treatment with any investigational drug within 4 weeks prior to Day -1 of the study.\n19. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus\n20. Have poorly controlled diabetes.\n21. Uncontrolled hypertension\n22. History of New York Heart Association (NYHA) class III or IV heart failure\n23. Serious concurrent illness, including psychiatric illness, that would interfere with study participation\n24. Inability to swallow tablets whole\n25. Known hypersensitivity to any excipients in study medications\n26. Moderate to severe hepatic impairment (Child-Pugh Classes B and C)'}, 'identificationModule': {'nctId': 'NCT02737332', 'acronym': 'STAAR', 'briefTitle': 'A Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharmaceutical Industries Limited'}, 'officialTitle': 'A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR STUDY', 'orgStudyIdInfo': {'id': 'CHL-AA-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Zytiga® (Abiraterone Acetate)', 'description': '1,000 MG (4 x 250 mg qd)', 'interventionNames': ['Drug: Zytiga® (Abiraterone Acetate)']}, {'type': 'EXPERIMENTAL', 'label': 'SoluMatrix™ (Abiraterone Acetate)', 'description': '500 mg (4 x 125 mg qd)', 'interventionNames': ['Drug: SoluMatrix™ (Abiraterone Acetate)']}], 'interventions': [{'name': 'Zytiga® (Abiraterone Acetate)', 'type': 'DRUG', 'otherNames': ['Zytiga®'], 'description': 'Zytiga® 1,000 mg (4 x 250 mg qd) tablets plus one 5 mg prednisone tablet to be taken bid, spaced approximately 12 hours apart', 'armGroupLabels': ['Zytiga® (Abiraterone Acetate)']}, {'name': 'SoluMatrix™ (Abiraterone Acetate)', 'type': 'DRUG', 'otherNames': ['SoluMatrix™'], 'description': 'SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart', 'armGroupLabels': ['SoluMatrix™ (Abiraterone Acetate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Alliance Research', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Urology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92404', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'San Bernardino Urological', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Skyline Urology', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Urology Associates, P.C.', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '34205', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Manatee Medical Research', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '83814', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': 'North Idaho Urology', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'The Iowa Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Wichita Urology Group', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Urology Research Associates', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '68516', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Lincoln Urology, PC', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Urology Cancer Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn Urology Research Group', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Associated Urologist of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology Clinics of North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Urology of Virginia', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}], 'overallOfficials': [{'name': 'Paul Nemeth, PhD', 'role': 'STUDY_DIRECTOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharmaceutical Industries Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}