Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

Summary

RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.

PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.

Conditions

• Metastatic Cancer
• Prostate Cancer

Interventions

DRUG

zoledronic acid

Given IV

OTHER

placebo

Given IV

DRUG

androgen deprivation therapy

Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive androgen deprivation therapy per SWOG-9346. All other patients will receive androgen deprivation therapy at a standard dose and schedule throughout the study.

DRUG

GnRH agonist

Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive the GnRH agonist per SWOG-9346. All other patients will receive GnRH agonist at a standard dose and schedule throughout the study.

DIETARY_SUPPLEMENT

Calcium supplement

Patients will receive 500 mg by mouth daily of a calcium supplement or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.

DIETARY_SUPPLEMENT

Vitamin D

Patients will receive a multivitamin tablet containing 400-500 IU vitamin D by mouth daily or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  collaborator NETWORK

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• NCIC Clinical Trials Group

  collaborator NETWORK

• Novartis Pharmaceuticals

  collaborator INDUSTRY

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Matthew R. Smith, MD, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2012-07-31

Completion

2014-10-31

Countries

• United States
• Canada

Study Locations