NCT00003832

Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer

Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: 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

• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Interventions

Type	Name	Description
DRUG	bromodeoxyuridine	Given IV
PROCEDURE	conventional surgery	Undergo surgery
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 1999-07-01
• Primary completion: 2002-06-01
• First posted: 2003-09-30
• Last updated: 2013-01-25

Locations

1 site across 1 country: United States