Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Inclusion Criteria: Aged ≥18 years. Written informed consent. With histologically-proven prostate carcinoma. ECOG performance status ≤ 2 Life expectancy > 12 months Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory) Patients with partners of childbearing potential should use a barrier method of contraception throughout the study. Exclusion Criteria: ECOG performans status >3 Prior treatment with bisphosphonates IV within the last 3 month to the study Renal insufficiency (serum creatinine > 265 micromol/L or > 3.0 mg/dL) Liver function tests > 2.5 ULN Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol. History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism Disabling or non controlled concomitant disease likely to alter the quality of life Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient Known hypersensitivity to zoledronic acid or other bisphosphonates Other protocol-defined inclusion / exclusion criteria may apply.