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

National Cancer Institute (NCI)75 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

bromodeoxyuridineDRUG

Given IV

conventional surgeryPROCEDURE

Undergo surgery

laboratory biomarker analysisOTHER

Correlative studies

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of stage I or II (T1-2) carcinoma of the prostate * PSA greater than 8 ng/mL * Abnormal findings on digital rectal examination * Eligible for radical prostatectomy * Performance status - ECOG 0 or 1 * No prior biologic therapy * No prior chemotherapy * No prior neoadjuvant hormonal therapy * No prior radiotherapy * See Disease Characteristics * No prior therapy that would affect tumor growth rates or volume

Locations (1)

University of Colorado

Denver, Colorado, United States

Outcomes

Primary Outcomes

Average doubling time between low and high volume tumors

Time frame: Up to 3 years

Data from ClinicalTrials.gov

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