Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer

A Phase III, Parallel Group, Randomized, Open-label, Multi-centre Clinical Trial of Zoledronic Acid in Males Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer.

This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment

Inclusion Criteria:

• prostate cancer
• at least one bone metastasis
• receiving or about to receive androgen deprivation therapy (ADT)

Exclusion Criteria:

• previous ADT failure
• previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy
• abnormal renal function

Other protocol-defined inclusion/exclusion criteria may apply.