Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Diagnostic, Treatment Completed Not specified NCI UCHSC-98374 NCI-T98-0058, NCT00003832, T98-0058

Objectives

1. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine.
2. 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.

Entry Criteria

Disease Characteristics:

• Diagnosis of stage I or II (T1-2) carcinoma of the prostate
  • PSA greater than 8 ng/mL

    AND

  • Abnormal findings on digital rectal examination



• Eligible for radical prostatectomy

Prior/Concurrent Therapy:

Biologic therapy:

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No prior neoadjuvant hormonal therapy

Radiotherapy:

• No prior radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No prior therapy that would affect tumor growth rates or volume

Patient Characteristics:

Age:

• Not specified

Performance status:

• ECOG 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Expected Enrollment

A total of 75 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Colorado Cancer Center at UC Health Sciences Center

L. Michael Glode, MD, Protocol chair		Ph: 970-240-7242 Email: mike.glode@uchsc.edu

Registry Information
Official Title		Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer
Trial Start Date		1999-07-01
Registered in ClinicalTrials.gov		NCT00003832
Date Submitted to PDQ		1999-03-25
Information Last Verified		2002-09-01
NCI Grant/Contract Number		P30-CA46934