Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT01337258
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2010-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Economic Analyses of the REDUCE Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D009369', 'term': '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': 'D000068538', 'term': 'Dutasteride'}], 'ancestors': [{'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2010-03-04', 'studyFirstSubmitQcDate': '2011-04-14', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost of treating prostate-related events', 'timeFrame': 'REDUCE clinical trial, 4 year time period', 'description': 'Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cost effectiveness', 'dutasteride', 'elevated risk population', 'Prostate cancer', 'prevention'], 'conditions': ['Neoplasms, Prostate', 'Benign Prostatic Hyperplasia', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment.\n\nThe REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men at increase risk for prostate cancer ages 50-75 who were enrolled in the REDUCE study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 50 to 75 years\n* serum prostate-specific antigen (PSA) ≥2.5 ng per milliliter and ≤10 ng per milliliter (men aged 50-60 years) or ≥3.0 ng per milliliter and ≤10 ng per milliliter (men aged \\>60 years)\n* single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment (independent of the study)\n\nExclusion Criteria:\n\n* Principal exclusion criteria were more than one prior prostate biopsy\n* high-grade intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy\n* a prostate volume \\>80 ml, previous prostate surgery\n* International Prostate Symptom Score (IPSS) ≥25 or ≥20 if already on alpha-blocker therapy for BPH'}, 'identificationModule': {'nctId': 'NCT01337258', 'briefTitle': 'Economic Analyses of the REDUCE Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Economic Analyses Alongside the REDUCE Clinical Trial', 'orgStudyIdInfo': {'id': '113979'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Men at increased risk for Prostate Cancer (PCA)', 'interventionNames': ['Drug: Dutasteride', 'Drug: Placebo']}], 'interventions': [{'name': 'Dutasteride', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'dutasteride 0.5mg daily.', 'armGroupLabels': ['Men at increased risk for Prostate Cancer (PCA)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Men taking placebo daily', 'armGroupLabels': ['Men at increased risk for Prostate Cancer (PCA)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}