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S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

NCT00004124 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 983

Last updated 2022-12-30

Study results available
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Summary

RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing 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 plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.

Conditions

Interventions

DRUG

bicalutamide

DRUG

goserelin

DRUG

mitoxantrone hydrochloride

DRUG

prednisone

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • L. Michael Glode, MD · University of Colorado, Denver

  • Nancy A. Dawson, MD · University of Maryland Greenebaum Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1999-10-15
Primary Completion
2017-08-12
Completion
2018-05-01

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 NCT00004124 on ClinicalTrials.gov