A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates
- Written informed consent must be obtained
- Age > 18 years
- Histologically confirmed diagnosis of carcinoma of the prostate
- Current (or previous) objective evidence of metastatic disease to the bone
- Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal
- ECOG performance status of 0, 1, or 2
- Patients with abnormal renal function as evidenced by either a serum creatinine
determination 1.5 x or greater above the upper limit of normal or by a calculated
creatinine clearance of 60 ml/minute or less
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00
- WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x
- Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
- Patients with another nonmalignant disease which would confound the evaluation of
primary endpoints or prevent the patient complying with the protocol.
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Subjects who, in the opinion of the investigator, are unlikely to cooperate fully
during the study
Other protocol-defined inclusion / exclusion criteria apply.