Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 2:12 PM
Study NCT ID:
NCT00673205
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2008-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(Bicalutamide) Casodex vs Placebo in Non-metastatic 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': 3588}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-09', 'studyFirstSubmitDate': '2008-05-02', 'studyFirstSubmitQcDate': '2008-05-06', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to clinical progression', 'timeFrame': 'Throughout study period'}, {'measure': 'Tolerability in terms of adverse events and laboratory parameters', 'timeFrame': 'Throughout study period'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Throughout study period'}, {'measure': 'Time to treatment failure', 'timeFrame': 'Throughout study period'}, {'measure': 'Prostate-specific antigen', 'timeFrame': 'Initial study period up to 2005 amended protocol'}]}, '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 of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of non-metastatic cancer of the prostate gland\n* Patient to be 18 years and above\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': 'NCT00673205', 'acronym': 'Capri', 'briefTitle': '(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer', 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