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

Stage I Prostate Cancer Clinical Trial

Official title:

Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003832
• Other study ID #: NCI-2012-02297
• Secondary ID: 98-374CDR0000066
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: January 24, 2013
• Start date: July 1999

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Intervention

Drug:
• bromodeoxyuridine
Given IV

Procedure:
• conventional surgery
Undergo surgery

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Colorado	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average doubling time between low and high volume tumors		Up to 3 years	No