Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
|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.
Other Names:Procedure: conventional surgery
Other Name: surgery, conventionalOther: laboratory biomarker analysis
- Average doubling time between low and high volume tumors [ Time Frame: Up to 3 years ]
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|