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.
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80217-3364|
|Principal Investigator:||Leonard Glode||University of Colorado, Denver|