Completed

Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

bromodeoxyuridine

+ conventional surgery

+ laboratory biomarker analysis

DrugProcedureOther
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 1999
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 25, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003832
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 25, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

75 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Colorado

Denver, United StatesOpen University of Colorado in Google Maps
CompletedOne Study Center