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Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer


Phase 2
N/A
N/A
Not Enrolling
Male
Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

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Trial Information

Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Average doubling time between low and high volume tumors

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Leonard Glode

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02297

NCT ID:

NCT00003832

Start Date:

July 1999

Completion Date:

Related Keywords:

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

Name

Location
University of Colorado Denver, Colorado  80217