Inclusion Criteria

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