A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Inclusion Criteria: Written informed consent must be obtained Age > 18 years Histologically confirmed diagnosis of carcinoma of the prostate Current (or previous) objective evidence of metastatic disease to the bone Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments ECOG performance status of 0, 1, or 2 Exclusion Criteria: Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 1'000'000'000/L. Liver function tests >2.5 ULN, serum creatinine >1.5 ULN. Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol. Known hypersensitivity to zoledronic acid or other bisphosphonates Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study Other protocol-defined inclusion / exclusion criteria apply.