A Randomized Double-Blind Placebo Controlled Phase III Trial Evaluating Zoledronate Plus Standard Therapy Versus Placebo Plus Standard Therapy in Patients With Recurrent Carcinoma of the Prostate Who Are Asymptomatic With Castrate Levels of Testosterone and Have Rising PSA Levels Without Radiologically-Evident Metastatic Disease
OBJECTIVES: I. Compare the bone metastases free and overall survival in patients with
asymptomatic recurrent prostate cancer treated with zoledronate vs placebo at different time
points. II. Compare the time to first skeletal related events (pathological fractures,
surgery to prevent or treat pathological fractures, spinal cord compression, and
radiotherapy to bone) and skeletal morbidity rate in patients treated with these 2 regimens.
III. Assess quality of life and pain in these patients treated with these 2 regimens.
OUTLINE: This is a randomized, double blind, placebo controlled, open label, multicenter
study. Patients are stratified by prior local treatment (noncurative vs curative) and time
interval between surgical castration or initiation of LHRH agonists and trial entry (less
than 1 year vs 1-2 years vs greater than 2 years). Patients are randomized to 1 of 2
treatment arms: Arm I: Patients receive zoledronate IV over 15 minutes on day 1. Arm II:
Patients receive placebo IV over 15 minutes on day 1. Both arms: Treatment repeats every 4
weeks in the absence of documented bone metastasis, disease progression, or unacceptable
toxicity. All patients with documented bone metastases receive zoledronate as in arm I
through year 4. All patients receive oral calcium and oral vitamin D daily. Patients who
received LHRH agonists instead of surgical castration prior to study continue LHRH agonist
therapy during study. Quality of life and pain are assessed before each treatment. Patients
are followed every 6 months.
PROJECTED ACCRUAL: A total of 500 patients (250 per arm) will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Fairooz F. Kabbinavar, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|