NCT00003832

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2002

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

September 30, 2003

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

2.9 years

First QC Date

November 1, 1999

Last Update Submit

January 24, 2013

Conditions

Stage I Prostate CancerStage IIA Prostate CancerStage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Average doubling time between low and high volume tumors

    Up to 3 years

Study Arms (1)

Treatment (bromodeoxyuridine)

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.

Drug: bromodeoxyuridineProcedure: conventional surgeryOther: laboratory biomarker analysis

Interventions

bromodeoxyuridineDRUG

Given IV

Also known as: 5-BrdU, 5-bromodeoxyuridine, BrdU, broxuridine
Treatment (bromodeoxyuridine)
conventional surgeryPROCEDURE

Undergo surgery

Also known as: surgery, conventional
Treatment (bromodeoxyuridine)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bromodeoxyuridine)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Denver, Colorado, 80217-3364, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bromodeoxyuridine5-bromouridineSurgical Procedures, OperativeCongresses as Topic

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesOrganizationsHealth Care Economics and Organizations

Study Officials

  • Leonard Glode

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 30, 2003

Study Start

July 1, 1999

Primary Completion

June 1, 2002

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)