Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases

Inclusion Criteria * Patients aged ≥18 years * Written informed consent * Histologically-proven prostate carcinoma * ECOG performance status ≤ 2 * Life expectancy \> 6 months * Newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph. * Patients on androgen deprivation therapy (medical therapy with LHRH analogues + antiandrogens or surgical castration) or going to start it * Patients with partners of childbearing potential should use a barrier method of contraception throughout the study Exclusion Criteria * Patients without a history of metastatic disease to the bone * Prior treatment with bisphosphonates * SREs prior to visit 2 * Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline * Corrected (adjusted for serum albumin - see Appendix 5 for the calculation) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l) * Serum creatinine concentration \> 265 micromol/l (3.0 mg/dl) or a calculated creatinine clearance \< 30 ml/minute or serious underlying renal disease or prior renal transplantation * History of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated * Other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future * Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days * Known hypersensitivity to zoledronic acid or other bisphosphonates * History of noncompliance to medical regimens and patients who are considered potentially unreliable (for example drug or alchohol abusers) or incapable of giving informed consent as judged by the investigator