MedTrace Logo

Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer

NCT01250717 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-02-04

Study results available
· View outcomes & findings →

Summary

The purpose of this research study is to determine if the combination of chemotherapy and hormone therapy is safe and helpful for patients who plan to have their high-risk prostate cancer surgically removed. Some physicians believe that patients with high risk cancer that is located in one area, may have an early but small spread of the cancer outside of the prostate, and perhaps even to distant organs. Therefore, better treatments for the entire body are needed to improve the ability of surgery or other local therapies to cure prostate cancer. Since chemotherapy is beginning to demonstrate increasing activity in advanced prostate cancer patients, it is possible that using chemotherapy combined with hormonal therapy earlier in the course of localized but high risk patients might improve the outcomes for these patients.

Conditions

Interventions

DRUG

Docetaxel

Given by an IV infusion over 1 hour on day 2 of a three-week cycle

DRUG

Dexamethasone

Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel

DRUG

Estramustine

Taken orally three times a day for 5 days for the first part of every three week cycle

DRUG

Zoladex

Given subcutaneously for 4 doses every three months

DRUG

Casodex

Taken orally once a day for 6 months

PROCEDURE

Radical Prostatectomy

after the chemo and hormonal therapy all patients have a radiacal prostatectomy

Sponsors & Collaborators

Principal Investigators

  • Glenn J. Bubley, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01250717 on ClinicalTrials.gov