Protocol Title:

A Phase III, Double-Blind, Placebo-Controlled Study to
Evaluate the Efficacy of Zometa for the Prevention of
Osteoporosis and Associated Fractures in Patients
Receiving Radiation Therapy and Long Term LHRH Agonists
for High-Grade and/or Locally Advanced Prostate Cancer

Protocol Status:

Open

Protocol Number:

R-0518

Type of Cancer:

Prostate

Physician:

Danny Song, M.D.

Research Nurse:

Shirl DiPasquale, R.N. & Beth Griffith, R.N.

Phase Number:

III

General Eligibility:

Patients with high-grade and/or locally advanced prostate cancer and who are being treated with radiation therapy along with long term agonists.

Purpose:

To evaluate the potential benefit of bisphosphonate therapy in the prevention of bone fracture (defined as any fractures of the bone) in patients receiving LHRH and radiation therapy for locally advanced adenocarcinoma of the prostate.

Treatment:

Eligible subjects will be stratified determined upon the duration of their LHRH therapy coupled with a score derived from a scan of your hip. Once these two are factored together the subject will receive (be randomized) either Zoledronic acid, vitamin D, and a calcium supplement or a placebo, vitamin D, and a calcium supplement.

***Note: This is a double-blinded study which means neither the treating physician nor the subject being treated will know to what arm of the study they have been randomized.