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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003832
First Posted: September 30, 2003
Last Update Posted: January 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
November 1, 1999
September 30, 2003
January 25, 2013
July 1999
June 2002   (Final data collection date for primary outcome measure)
Average doubling time between low and high volume tumors [ Time Frame: Up to 3 years ]
Not Provided
Complete list of historical versions of study NCT00003832 on ClinicalTrials.gov Archive Site
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Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
Cell Kinetic Study of Bromodeoxyuridine (BrdU) in 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

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • 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
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.
Interventions:
  • Drug: bromodeoxyuridine
  • Procedure: conventional surgery
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
Not Provided
June 2002   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003832
NCI-2012-02297
98-374
CDR0000066989 ( Registry Identifier: PDQ (Physician Data Query) )
Not Provided
Not Provided
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Leonard Glode University of Colorado, Denver
National Cancer Institute (NCI)
January 2013

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