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Preventing Bone Fractures in Prostate Cancer Patients
Untitled Document
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.
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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.
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