Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01428869
Status:
COMPLETED
Last Update Posted:
2011-09-09
First Post:
2011-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], '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'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Specimens were retained as part of the REDUCE protocol, but no biospecimens are required for the current protocol.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-08', 'studyFirstSubmitDate': '2011-08-26', 'studyFirstSubmitQcDate': '2011-09-01', 'lastUpdatePostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of Prostate Cancer', 'timeFrame': '4 years', 'description': 'The relative risk of prostate cancer development in REDUCE study participants treated with a combination of statins, acetylsalicylic acid and dutasteride.'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of High Grade Prostate Cancer', 'timeFrame': '4 years', 'description': 'The relative risk of high grade prostate cancer development in REDUCE study participants treated with a combination of statins, acetylsalicylic acid and dutasteride'}, {'measure': 'Improvement of Lower Urinary Tract Symptoms', 'timeFrame': '4 years', 'description': 'The impact of combination statin, acetylsalicylic acid and dutasteride use on lower urinary tract symptoms in REDUCE study participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Statins', 'acetylsalicylic acid', 'dutasteride', 'Prostate Cancer', 'Lower urinary tract symptoms', 'prevention', 'drug interactions'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether there is any interaction between statins, acetylsalicylic acid (ASA) and dutasteride on protection from prostate cancer, the development of high grade prostate cancer, or lower urinary tract symptoms.', 'detailedDescription': 'A review of data collected from REDUCE (REduction by DUtasteride of prostate Cancer Events) study participants will be performed. Data required for the analysis includes: ethnicity, prostate specific antigen (PSA) levels, prostate volumes, presence of diabetes, concomitant medication use (for statin and ASA), prostate biopsy results at 2 and 4 years, body mass index (BMI), digital rectal exam (DRE) results, family history of Prostate Cancer and benign prostatic hyperplasia (BPH) outcomes: urinary retention, international prostate symptom score (IPSS), urinary tract infections (UTI)s.\n\nThe association of drug interactions with prostate cancer will be explored by using a multivariate logistic regression model including all possible interaction terms between dutasteride, ASA and statins (i.e. statin+ASA+dutasteride, statin+ASA, dutasteride+statin, dutasteride+ASA). Any interaction term found to be insignificant ( i.e. p\\>0.05) will be removed from the model. If a statistically significant interaction term is identified, the study cohort will be stratified by drug use, and the relative risk (RR)of prostate cancer among the different drug users will be reported. To control for potential confounders, a multivariate regression model will be constructed adjusting for age, family history of prostate cancer, DRE results and BMI.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants of the REDUCE trial (negative prostate biopsy at baseline) who had at least one post-baseline prostate biopsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who received dutasteride or placebo and had at least one post-baseline prostate biopsy\n\nExclusion Criteria:\n\n* Participants not taking concomitant statins or ASA'}, 'identificationModule': {'nctId': 'NCT01428869', 'briefTitle': 'Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'The Effect of Combination Statin, Acetylsalicylic Acid and Dutasteride Use on Prostate Cancer - a Sub Analysis of the REDUCE Trial', 'orgStudyIdInfo': {'id': '10-1000AE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'statin+ASA+dutasteride'}, {'label': 'statin+ASA'}, {'label': 'dutasteride+statin'}, {'label': 'dutasteride+ASA'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Neil E Fleshner, MD MPH FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}