Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-22 @ 9:27 AM
Study NCT ID:
NCT00572468
Status:
COMPLETED
Last Update Posted:
2017-07-13
First Post:
2007-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Statin Therapy Versus Placebo Prior to Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D019821', 'term': 'Simvastatin'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wesley.stoller@va.gov', 'phone': '503-220-8262', 'title': 'Wesley Stoller', 'phoneExt': '54931', 'organization': 'Portland VA Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).', 'eventGroups': [{'id': 'EG000', 'title': 'Simvastatin', 'description': 'Participants were randomized into the Simvastatin arm of this trial.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants were randomized into the placebo arm of this trial.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Penile pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Catheter discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Bloody drainage from wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'Participants were randomized into the Simvastatin arm of this trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized into the placebo arm of this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '168.6666667', 'groupId': 'OG000', 'lowerLimit': '142.4517', 'upperLimit': '194.882'}, {'value': '182.7272727', 'groupId': 'OG001', 'lowerLimit': '161.46353', 'upperLimit': '203.99107'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 years', 'description': 'Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue using Androgen Receptor (AR) antibody. AR was measured in tissue obtained at the time of prostatectomy in both benign and malignant tissues.', 'unitOfMeasure': 'Percentage of cells', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.'}, {'type': 'SECONDARY', 'title': 'Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Simvastatin', 'description': 'Participants were randomized into the Simvastatin arm of this trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized into the placebo arm of this trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.53333', 'groupId': 'OG000', 'lowerLimit': '3.95134', 'upperLimit': '11.11532'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1.87843', 'upperLimit': '10.12157'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'Compare the effect of pre-operative simvastatin versus placebo on prostate cancer cell apoptosis and its mediators in men undergoing planned prostatectomy. Apoptosis was measured by calculating the percent of Ki67 cellular staining.', 'unitOfMeasure': 'Percentage of cells', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Simvastatin', 'description': 'Participants were randomized into the Simvastatin arm of this trial.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants were randomized into the placebo arm of this trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Simvastatin', 'description': 'Participants were randomized into the Simvastatin arm of this trial.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants were randomized into the placebo arm of this trial.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '71'}, {'value': '60.75', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '73'}, {'value': '60.56', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '73'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_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': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2007-12-11', 'resultsFirstSubmitDate': '2017-04-17', 'studyFirstSubmitQcDate': '2007-12-11', 'lastUpdatePostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-13', 'studyFirstPostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.', 'timeFrame': '5 years', 'description': 'Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue using Androgen Receptor (AR) antibody. AR was measured in tissue obtained at the time of prostatectomy in both benign and malignant tissues.'}], 'secondaryOutcomes': [{'measure': 'Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy.', 'timeFrame': '2 years', 'description': 'Compare the effect of pre-operative simvastatin versus placebo on prostate cancer cell apoptosis and its mediators in men undergoing planned prostatectomy. Apoptosis was measured by calculating the percent of Ki67 cellular staining.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cancer', 'pre-operative surgery', 'prostate', 'prostatectomy', 'radiation'], 'conditions': ['Cancer', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a randomized trial comparing the effect of oral simvastatin versus placebo on targets of the mevalonate pathway in men undergoing a prostatectomy as planned management for prostate cancer. Observed tissue effects will be correlated with changes in serum cholesterol and low-density lipoprotein.', 'detailedDescription': 'Prostate cancer patients that have chosen to undergo a prostatectomy as their primary treatment option will be recruited to this trial. Forty-four subjects will be randomized to either placebo or simvastatin (40 mg po/day) for 4 weeks prior to surgery. Serum samples will be obtained at baseline and immediately prior to prostatectomy. At prostatectomy, cancerous and benign prostate tissue will be microdissected and cryopreserved. Archival prostatectomy tissues will be used to construct tissue microarrays containing matched benign and malignant sections. The effect of HMG-CoA reductase inhibition on lipid raft cholesterol content and targets of prenylation will be determined. The incidence of apoptosis will be determined along with protein levels of mediators of apoptosis. Lastly the effect of statin therapy on cellular markers of proliferation will be determined.\n\nPreviously, we studied the effect of statin use on the risk of prostate cancer detection in a case-control study at the Portland VA Medical Center. Statin use was associated with a 62% reduction in cancer odds-risk (OR = 0.38, 95% CI 0.21-0.69). Although these epidemiologic and laboratory findings have generated enthusiasm for the study of statins in prostate cancer, no studies have examined the biologic effects of statins on prostate cancer in humans.\n\nHypothesis: Statin therapy prior to prostatectomy will successfully target the mevalonate pathway in the human prostate and this intervention will favorably alter tumor biomarker status.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed prostatic adenocarcinoma with Gleason 5 to 7 (3+4 = 7 accepted, not 4 + 3 = 7)\n* Radical prostatectomy chosen as primary treatment for prostate cancer\n* Age 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Other preoperative or prior treatment directed at prostate cancer (i.e., Radiation, hormonal therapy, cryotherapy)\n* Significant active medical illness which in the opinion of the investigator would preclude protocol treatment\n* History of or active liver disease or abnormal results of the baseline liver function test (\\> 2 x normal)\n* Current use of:\n\n * simvastatin\n * lovastatin\n * other HMG-CoA inhibitors\n * lipid-lowering agents\n * Amiodarone\n * Cholestyramine\n * Cholestyramine and colestipol (bile acid sequestrants)\n * Clofibrate and fenofibrate\n * Cyclosporine\n * CYP3A4 inhibitors\n * Danazol\n * Diltiazem\n * Gemfibrozil\n * Niacin ( 1 g/day)\n * Verapamil and Warfarin\n* Known allergy or sensitivity to ingredients in simvastatin'}, 'identificationModule': {'nctId': 'NCT00572468', 'briefTitle': 'Statin Therapy Versus Placebo Prior to Prostatectomy', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Pre-Operative Statin Therapy Versus Placebo in Human Prostate Cancer', 'orgStudyIdInfo': {'id': 'CLIN-013-07S'}, 'secondaryIdInfos': [{'id': 'VA IRB#1735', 'type': 'OTHER', 'domain': 'VA IRB'}, {'id': 'SOL-07130-L', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute Identifier'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Simvastatin', 'description': 'Twenty-two men will be on the Statin arm and take 40 mg of simvastatin.', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Twenty-two men will be on the placebo arm.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['statin'], 'description': '40 mg of simvastatin', 'armGroupLabels': ['Simvastatin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center, Durham, NC', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97201', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Medical Center, Portland', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Mark Garzotto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Medical Center, Portland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}