Back to resultsBroxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
Primary Purpose
Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bromodeoxyuridine
conventional surgery
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Stage I Prostate Cancer
Eligibility 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
Sites / Locations
- University of Colorado
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (bromodeoxyuridine)
Arm Description
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.
Outcomes
Primary Outcome Measures
Average doubling time between low and high volume tumors
Secondary Outcome Measures
Full Information
NCT ID
NCT00003832
First Posted
November 1, 1999
Last Updated
January 24, 2013
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00003832
Brief Title
Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
Official Title
Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (bromodeoxyuridine)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bromodeoxyuridine
Other Intervention Name(s)
5-BrdU, 5-bromodeoxyuridine, BrdU, broxuridine
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Other Intervention Name(s)
surgery, conventional
Intervention Description
Undergo surgery
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Average doubling time between low and high volume tumors
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Glode
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
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