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

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ClinicalTrials.gov Identifier: NCT00003832
Recruitment Status : Completed
First Posted : September 30, 2003
Last Update Posted : January 25, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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 or disease Intervention/treatment Phase
Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Drug: bromodeoxyuridine Procedure: conventional surgery Other: laboratory biomarker analysis Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer
Study Start Date : July 1999
Actual Primary Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Average doubling time between low and high volume tumors [ Time Frame: Up to 3 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003832


Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80217-3364
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Leonard Glode University of Colorado, Denver

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003832     History of Changes
Other Study ID Numbers: NCI-2012-02297
98-374
CDR0000066989 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 30, 2003    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

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
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents