An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Inclusion Criteria

Inclusion criteria:

- Signed informed consent

- Age > 18 years

- Histologically confirmed diagnosis of carcinoma of the prostate

- Objective evidence of metastatic disease to the bone as evidenced by bone scan or
radiograph at any point since their diagnosis of prostate cancer

- Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist
or other hormonal treatments for either < 6 months or > 6 months

- ECOG performance status of 0, 1, or 2

Exclusion criteria:

- Patients who are hormone sensitive without metastatic disease to the bone

- Patients who are hormone refractory typically defined as two or three consecutive
increases in PSA measured at least one month apart while on hormone therapy

- Patients who are not treated with LHRH agonist or other hormonal treatments

- Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES

- Patients with another nonmalignant disease which would confound the evaluation of
primary endpoints or prevent the patient complying with the protocol.

- Patients with abnormal renal function as evidenced by either a serum creatinine
greater than 2 mg/dL 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
mmol/L)