Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
NCT ID: NCT00003832
Last Updated: 2013-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
1999-07-31
Brief Summary
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Detailed Description
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I. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine.
II. 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.
OUTLINE:
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (bromodeoxyuridine)
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.
bromodeoxyuridine
Given IV
conventional surgery
Undergo surgery
laboratory biomarker analysis
Correlative studies
Interventions
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bromodeoxyuridine
Given IV
conventional surgery
Undergo surgery
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PSA greater than 8 ng/mL
* Abnormal findings on digital rectal examination
* Eligible for radical prostatectomy
* Performance status - ECOG 0 or 1
* No prior biologic therapy
* No prior chemotherapy
* No prior neoadjuvant hormonal therapy
* No prior radiotherapy
* See Disease Characteristics
* No prior therapy that would affect tumor growth rates or volume
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Leonard Glode
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado
Denver, Colorado, United States
Countries
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Other Identifiers
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98-374
Identifier Type: -
Identifier Source: secondary_id
CDR0000066989
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02297
Identifier Type: -
Identifier Source: org_study_id
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