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.