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Featured Clinical Trials

Highlighted NCI-Supported Cancer Studies
  • Posted: 09/07/2004
  • Updated: 02/28/2006

Preventing Bone Fractures in Prostate Cancer Patients

Name of the Trial

Phase III Randomized Study of Zoledronate for the Prevention of Skeletal-Related Events in Patients With Prostate Cancer and Bone Metastases Undergoing Androgen Deprivation Therapy (CALGB-90202). See the protocol summary.

Principal Investigator

Dr. Matthew Smith, Cancer and Leukemia Group B.

Dr. Matthew Smith
Dr. Matthew Smith
Principal Investigator

Why This Trial Is Important

Advanced prostate cancer often spreads to bones, a condition called bone metastases. Men with bone metastases are at risk for a variety of complications, including bone pain, fractures, and spinal cord compression. The mainstay of treatment for metastatic prostate cancer is androgen deprivation therapy, a treatment that markedly reduces levels of testosterone and other androgens (male hormones) in the body.

This study will evaluate the ability of zoledronic acid (Zometa®), one of a family of drugs known as bisphosphonates, to prevent bone complications when administered at the same time as or shortly following androgen deprivation therapy. Currently, zoledronic acid is given to prostate cancer patients after androgen deprivation has stopped working.

"We know that zoledronic acid inhibits bone resorption and that it reduces problems such as fractures, spinal column compression, and pain associated with bone metastases after androgen deprivation therapy has failed," said Dr. Smith. "The question this trial is intended to answer is whether giving zoledronic acid to patients earlier, while they are still responding to androgen deprivation therapy, will result in improved outcomes."

Who Can Join This Trial

Researchers seek to enroll 680 patients with confirmed diagnoses of prostate cancer and bone metastases who are undergoing androgen deprivation therapy. See the list of eligibility criteria for this trial.

Study Sites and Contact Information

Study sites in the United States are recruiting patients for this trial. See the list of study site contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.