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Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
This study has been completed.
Study NCT00003832   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes

November 1, 1999
February 6, 2009
July 1999
 
 
 
Complete list of historical versions of study NCT00003832 on ClinicalTrials.gov Archive Site
 
 
 
Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer

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.

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.

Phase II
Interventional
Treatment
Prostate Cancer
  • Drug: bromodeoxyuridine
  • Other: fluorescent antibody technique
  • Procedure: conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Male
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003832
 
CDR0000066989, UCHSC-98374, NCI-T98-0058
University of Colorado at Denver and Health Sciences Center
National Cancer Institute (NCI)
Study Chair: L. Michael Glode, MD Montrose Memorial Hospital Cancer Center
National Cancer Institute (NCI)
September 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP