Prevention of 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 at http://cancer.gov/clinicaltrials/CALGB-90202.
Dr. Matthew Smith of Cancer and Leukemia Group B.
Why Is This Trial 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 fractures, spinal cord compression, and bone pain. 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 zoledronate (Zometa), one of a family of drugs known as bisphosphonates, to prevent fractures and other bone complications when administered at the same time as or shortly following androgen deprivation therapy. Currently, zoledronate is given to prostate cancer patients after androgen deprivation has stopped working.
"We know that zoledronate inhibits bone resorption and that it reduces problems such as fractures, spinal column compression, and pain associated with bone metastases," said Dr. Smith. "The question this trial is intended to answer is whether giving zoledronate 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 full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/CALGB-90202.
Where Is This Trial Taking Place?
Study sites in the United States are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/CALGB-90202.
Who to Contact
See the list of study contacts at http://cancer.gov/clinicaltrials/CALGB-90202 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.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.