Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis
- 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
- Patients with partners of childbearing potential should use a barrier method of
contraception throughout the study.
- 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.