NCT00108290

Brief Summary

In men with prostate cancer who do not have evidence of spread to bone or other sites on computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy is being given for 6 months followed by surgery to remove the prostate.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 4, 2008

Status Verified

April 1, 2007

First QC Date

April 14, 2005

Last Update Submit

April 2, 2008

Conditions

Prostate Cancer

Keywords

Prostate cancerchemotherapyhormone therapysurgeryPSAGleason score

Interventions

ChemotherapyDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High risk prostate cancer without evidence of bone metastasis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

April 14, 2005

First Posted

April 15, 2005

Study Start

April 1, 2004

Study Completion

March 1, 2007

Last Updated

April 4, 2008

Record last verified: 2007-04

Locations

US(1)