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Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases

NCT00685646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2015-10-16

No results posted yet for this study

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen blockade therapy may lessen the amount of androgens made by the body. Zoledronic acid may help relieve some of the symptoms caused by bone metastasis. It is not yet known whether androgen-blockade therapy is more effective with or without zoledronic acid in treating patients with prostate cancer that has spread to the bone.

PURPOSE: This randomized phase III trial is studying androgen-blockade therapy given together with zoledronic acid to see how well it works compared with androgen-blockade therapy alone in treating patients with prostate cancer and bone metastases.

Conditions

Interventions

DRUG

antiandrogen therapy

Up to 24 courses of therapy

DRUG

zoledronic acid

Up to 24 courses of therapy

Sponsors & Collaborators

  • Kyoto University, Graduate School of Medicine

    collaborator OTHER

  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

    lead OTHER

Principal Investigators

  • Osamu Ogawa, MD, Ph.D. · Kyoto University, Graduate School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Japan

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 NCT00685646 on ClinicalTrials.gov