Zoledronate Plus Standard Therapy Compared With Placebo Plus Standard Therapy to Prevent Bone Metastases in Patients With Recurrent Prostate Cancer That Has No Symptoms

Prostate Cancer Clinical Trial

Official title: 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

Status Terminated

Clinical Trial Summary

RATIONALE: Zoledronate may be able to prevent bone metastases caused by prostate cancer. It is not yet known if zoledronate is effective in preventing the spread of prostate cancer to the bones.

PURPOSE: Randomized phase III trial to determine the effectiveness of zoledronate plus standard therapy in preventing bone metastases in patients who have recurrent prostate cancer that is not causing symptoms.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00005073
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 3
• Start date: September 1999
• Completion date: March 2003