MedTrace Logo

SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer

NCT00002651 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3040

Last updated 2017-04-17

Study results available
· View outcomes & findings →

Summary

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer.

PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.

Conditions

Interventions

DRUG

bicalutamide

Given orally

DRUG

goserelin acetate

Given subcutaneously

OTHER

clinical observation

Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Maha Hadi A. Hussain, MD · University of Michigan Rogel Cancer Center

  • Bryan J. Donnelly, MD, FRCSC, MSC · Tom Baker Cancer Centre - Calgary

  • Eric J. Small, MD · University of California, San Francisco

  • George Wilding, MD · University of Wisconsin, Madison

  • Atif Akdas, MD · Marmara University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT00002651 on ClinicalTrials.gov