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Clinical Trial CALGB 90202 Description This study will test whether early treatment with a medication (zoledronic acid) will reduce the risk of bone pain and fracture in prostate cancer patients. Requirements
Synopsis Men who are diagnosed with prostate cancer may develop cancer in the bones known as bone metastasis. Metastasis can cause pain and fractures. The standard practice is to administer zoledronic acid when such a problem develops. However, similar treatment early on may help prevent bone problems in prostate cancer patients. Zoledronic acid is a type of drug that has long been used to control skeletal problems associated with breast cancer, multiple myeloma, prostate cancer, and other solid tumors. Patients introduced into the study will randomly be assigned Zoledronic acid or a placebo. If, however, metastasis occurs, the patient will immediately be removed from the study medication and given standard over-the-counter zoledronic acid, which would always have been the standard treatment. If the patient develops a skeletal related "event" (bone fracture, spinal cord compression or surgery, or radiation to the bones), he will be removed from the study entirely and continue to be treated by the physician off-study. The CALGB hopes to enroll 680 men on the study. It opened in January of 2004 and to date 50 men have been enrolled. If you are interested in participating in this trial, or would like more information, please contact our office.
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Eastern Shore Urology Associates, PA
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