Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT00840294
Status:
TERMINATED
Last Update Posted:
2014-08-01
First Post:
2009-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seggener@surgery.bsd.uchicago.edu', 'phone': '(773) 702-5195', 'title': 'Scott Eggener', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to poor accrual and interim futility analysis.'}}, 'adverseEventsModule': {'timeFrame': 'during the 2 weeks of study treatment', 'description': 'Subjects with complete data are included.', 'eventGroups': [{'id': 'EG000', 'title': 'Observation', 'description': 'Observation only for 2 weeks', 'otherNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Antibiotic', 'description': 'Ciprofloxacin 500 mg twice daily for 2 weeks', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in PSA Level From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation', 'description': 'Observation only for 2 weeks'}, {'id': 'OG001', 'title': 'Antibiotic', 'description': 'Ciprofloxacin 500 mg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 21-45 days after randomization', 'description': 'To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization.\n\nDue to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline).', 'unitOfMeasure': 'log ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with complete data are included'}, {'type': 'SECONDARY', 'title': 'Overall Infectious Complication Rate Following Prostate Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observation', 'description': 'Observation only for 2 weeks'}, {'id': 'OG001', 'title': 'Antibiotic', 'description': 'Ciprofloxacin 500 mg twice daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9.0'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '13.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours of biopsy', 'description': 'To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with complete data are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Observation', 'description': 'Observation only for 2 weeks'}, {'id': 'FG001', 'title': 'Antibiotic', 'description': 'Ciprofloxacin 500 mg twice daily for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'These are the subjects included in the baseline, outcomes, and adverse events tables', 'groupId': 'FG000', 'numSubjects': '39'}, {'comment': 'These are the subjects included in the baseline, outcomes, and adverse events tables', 'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Observation', 'description': 'Observation only for 2 weeks'}, {'id': 'BG001', 'title': 'Antibiotic', 'description': 'Ciprofloxacin 500 mg twice daily for 2 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'groupId': 'BG000', 'lowerLimit': '55.5', 'upperLimit': '66.7'}, {'value': '60.4', 'groupId': 'BG001', 'lowerLimit': '53.1', 'upperLimit': '66.6'}, {'value': '60.6', 'groupId': 'BG002', 'lowerLimit': '53.1', 'upperLimit': '66.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PSA level', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '2.4', 'upperLimit': '17.4'}, {'value': '7.6', 'groupId': 'BG001', 'lowerLimit': '3.1', 'upperLimit': '45.7'}, {'value': '7.0', 'groupId': 'BG002', 'lowerLimit': '2.4', 'upperLimit': '45.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Subjects with complete data are included'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'whyStopped': 'Combination of futility analysis and poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-07', 'studyFirstSubmitDate': '2009-02-09', 'resultsFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-07', 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PSA Level From Baseline', 'timeFrame': 'At baseline and 21-45 days after randomization', 'description': 'To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization.\n\nDue to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline).'}], 'secondaryOutcomes': [{'measure': 'Overall Infectious Complication Rate Following Prostate Biopsy', 'timeFrame': 'Within 24 hours of biopsy', 'description': 'To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Men with Elevated PSA'], 'conditions': ['Elevated Prostate Specific Antigen']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the impact of an empiric course of antibiotics for men with an elevated prostate-specific antigen (PSA) level.', 'detailedDescription': 'Study Objectives:\n\nPrimary Objective: To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy\n\nSecondary Objective: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy\n\nThe impact of observation versus ciprofloxacin on PSA levels will be assessed by PSA change from baseline. The first PSA measurement will be at the study entry and randomization. The second PSA measurement will be immediately prior to prostate biopsy, which will occur 21-45 days following randomization.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men 18 yrs. or older\n* An elevated PSA (\\>2.5 ng/ml) and normal digital rectal exam\n* Have elected to proceed with a diagnostic 12-core prostate biopsy\n\nExclusion Criteria:\n\n* Previous prostate biopsy\n* History of prostate cancer\n* Urinary tract infections or prostatitis within one year of study entry\n* antibiotic use within one month prior to PSA level\n* pyuria or bacteruria on urinalysis\n* allergy to fluoroquinolones'}, 'identificationModule': {'nctId': 'NCT00840294', 'briefTitle': 'Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)', 'orgStudyIdInfo': {'id': '16368B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Observation', 'description': 'Observation only for 2 weeks'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antibiotic', 'description': 'Ciprofloxacin 500 mg twice daily for 2 weeks', 'interventionNames': ['Drug: Ciprofloxacin']}], 'interventions': [{'name': 'Ciprofloxacin', 'type': 'DRUG', 'otherNames': ['Cipro'], 'armGroupLabels': ['Antibiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Scott Eggener, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}