Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00003832|
Recruitment Status : Completed
First Posted : September 30, 2003
Last Update Posted : January 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer||Drug: bromodeoxyuridine Procedure: conventional surgery Other: laboratory biomarker analysis||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||June 2002|
Experimental: 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.
Procedure: conventional surgery
Other Name: surgery, conventional
Other: laboratory biomarker analysis
- Average doubling time between low and high volume tumors [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003832
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80217-3364|
|Principal Investigator:||Leonard Glode||University of Colorado, Denver|