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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003832
First received: November 1, 1999
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Drug: bromodeoxyuridine
Procedure: conventional surgery
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Average doubling time between low and high volume tumors [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: July 1999
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: bromodeoxyuridine
Given IV
Other Names:
  • 5-BrdU
  • 5-bromodeoxyuridine
  • BrdU
  • broxuridine
Procedure: conventional surgery
Undergo surgery
Other Name: surgery, conventional
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003832

Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80217-3364
Sponsors and Collaborators
Investigators
Principal Investigator: Leonard Glode University of Colorado, Denver
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003832     History of Changes
Other Study ID Numbers: NCI-2012-02297, 98-374, CDR0000066989
Study First Received: November 1, 1999
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bromodeoxyuridine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014