Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT00657904
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2008-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C053541', 'term': 'bicalutamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3618}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2008-04-07', 'studyFirstSubmitQcDate': '2008-04-11', 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to clinical progression', 'timeFrame': 'Throughout study period'}, {'measure': 'Overall patient survival', 'timeFrame': 'Throughout study period'}], 'secondaryOutcomes': [{'measure': 'Time to treatment failure', 'timeFrame': 'Throughout study period'}, {'measure': 'Serum prostate-specific antigen', 'timeFrame': 'Initial study period up to 2006 amended protocol'}, {'measure': 'Tolerability in terms of adverse events and laboratory parameters', 'timeFrame': 'Throughout study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['androgen antagonists', 'prostate neoplasms'], 'conditions': ['Non-metastatic Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '22129214', 'type': 'DERIVED', 'citation': "Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81. doi: 10.1111/j.1464-410X.2010.09319.x."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate cancer in the early stage of disease\n* Prostate removed and/or radiation therapy to the prostate area\n\nExclusion Criteria:\n\n* Previous systemic therapy for prostate cancer\n* Previous history of another form of cancer (not prostate) within 5 years of study start.'}, 'identificationModule': {'nctId': 'NCT00657904', 'briefTitle': 'Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.', 'orgStudyIdInfo': {'id': 'D6876C00023'}, 'secondaryIdInfos': [{'id': '7054IL/0023'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Bicalutamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bicalutamide', 'type': 'DRUG', 'otherNames': ['Casodex™'], 'description': '150mg daily', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Mobile', 'state': 'Alabama', 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