Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-28 @ 10:17 AM
Study NCT ID:
NCT00003832
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II 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': 'D001973', 'term': 'Bromodeoxyuridine'}, {'id': 'C006824', 'term': '5-bromouridine'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D003857', 'term': 'Deoxyuridine'}, {'id': 'D014529', 'term': 'Uridine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-24', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-09-29', 'lastUpdatePostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average doubling time between low and high volume tumors', 'timeFrame': 'Up to 3 years'}]}, 'conditionsModule': {'conditions': ['Stage I Prostate Cancer', 'Stage IIA Prostate Cancer', 'Stage IIB Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of broxuridine in treating patients who are undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment', 'detailedDescription': 'OBJECTIVES:\n\nI. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine.\n\nII. Determine whether the doubling times of multifocal carcinomas occurring within a single prostate are consistent with a model in which low-volume carcinomas have slow doubling times and high-volume carcinomas have fast doubling times.\n\nOUTLINE:\n\nPatients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate. Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stage I or II (T1-2) carcinoma of the prostate\n\n * PSA greater than 8 ng/mL\n * Abnormal findings on digital rectal examination\n* Eligible for radical prostatectomy\n* Performance status - ECOG 0 or 1\n* No prior biologic therapy\n* No prior chemotherapy\n* No prior neoadjuvant hormonal therapy\n* No prior radiotherapy\n* See Disease Characteristics\n* No prior therapy that would affect tumor growth rates or volume'}, 'identificationModule': {'nctId': 'NCT00003832', 'briefTitle': 'Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer', 'orgStudyIdInfo': {'id': 'NCI-2012-02297'}, 'secondaryIdInfos': [{'id': '98-374'}, {'id': 'CDR0000066989', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (bromodeoxyuridine)', 'description': 'Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate.Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.', 'interventionNames': ['Drug: bromodeoxyuridine', 'Procedure: conventional surgery', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'bromodeoxyuridine', 'type': 'DRUG', 'otherNames': ['5-BrdU', '5-bromodeoxyuridine', 'BrdU', 'broxuridine'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (bromodeoxyuridine)']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'otherNames': ['surgery, conventional'], 'description': 'Undergo surgery', 'armGroupLabels': ['Treatment (bromodeoxyuridine)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (bromodeoxyuridine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80217-3364', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Leonard Glode', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}