Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
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
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Procedure: conventional surgery
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer|
- Average doubling time between low and high volume tumors [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 1999|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003832
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80217-3364|
|Principal Investigator:||Leonard Glode||University of Colorado, Denver|