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 at http://cancer.gov/clinicaltrials/CALGB-90202. This trial was previously featured in the September 7, 2004, NCI Cancer Bulletin.

Principal Investigator
Dr. Matthew Smith, Cancer and Leukemia Group B

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 intends 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 at http://cancer.gov/clinicaltrials/CALGB-90202.

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study site contacts at http://cancer.gov/clinicaltrials/CALGB-90202, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.