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

This study has been completed.

First Received: November 1, 1999 Last Updated: February 6, 2009 History of Changes

Sponsor:	University of Colorado at Denver and Health Sciences Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003832

Purpose

RATIONALE: Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment.

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: bromodeoxyuridine Other: fluorescent antibody technique Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Surgery

Drug Information available for: Bromodeoxyuridine

U.S. FDA Resources

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

Study Start Date:

July 1999

Detailed Description:

OBJECTIVES:

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

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

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

ECOG 0 or 1

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

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

Contacts and Locations

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

Locations

United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

National Cancer Institute (NCI)

Investigators

Study Chair:

L. Michael Glode, MD

Montrose Memorial Hospital Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066989, UCHSC-98374, NCI-T98-0058
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003832 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:

Bromodeoxyuridine
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Urogenital Neoplasms
Genital Diseases, Male
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009