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Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

NCT00027859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-06-15

No results posted yet for this study

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective than combination chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression.

Conditions

Interventions

DRUG

docetaxel

DRUG

estramustine phosphate sodium

DRUG

ketoconazole

DRUG

therapeutic hydrocortisone

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Michael A. Carducci, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Nirmala Bhoopalam, MD · Veterans Affairs Medical Center - Hines

  • Gregory P. Swanson, MD · Deaconess Medical Center, Spokane, Washington

  • William Dahut, MD · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-08
Primary Completion
2004-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00027859 on ClinicalTrials.gov