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Completed

NCT Number: NCT00003832

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

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

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Key information

Conditions

Stage I Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage IIA Prostate Cancer Stage IIB Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado

Denver, Colorado, 80217-3364, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bromodeoxyuridine

Drug

Given IV

Other names: 5-BrdU, 5-bromodeoxyuridine, BrdU, broxuridine

conventional surgery

Procedure

Undergo surgery

Other names: surgery, conventional

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Average doubling time between low and high volume tumors

    Time frame: Up to 3 years

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer

Important dates

Study start
1999
Primary completion
2002
First posted
Sep 30, 2003
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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