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

Phase 2

Completed

• Conditions: Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
• Interventions: Drug: bromodeoxyuridine; Procedure: conventional surgery; Other: laboratory biomarker analysis

• Registration Number: NCT00003832
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-06
• Study First Submitted QC: 2003-09-29
• Study First Posted: 2003-09-30
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (bromodeoxyuridine)	conventional surgery	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.
Treatment (bromodeoxyuridine)	laboratory biomarker analysis	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.
Treatment (bromodeoxyuridine)	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.

Primary Outcome Measures

Name	Time	Method
Average doubling time between low and high volume tumors	Up to 3 years

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Denver, Colorado, United States