Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

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• 2. Staging: At least one bone metastasis by radiographic imaging (bone scan, magnetic resonance imaging, computed tomography, or plain radiographs). Indeterminate lesions should be confirmed by a second imaging method. Imaging to document bone metastases is to be completed either within 12 weeks before registration or within 12 weeks before initiating androgen deprivation therapy for bone metastases.
• 3. Hormone Therapy
• * While on this study, patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer. Androgen deprivation therapy may have begun prior to enrollment on this study; however patients must have initiated ADT ≤ 6 months prior to enrollment.
• * Androgen deprivation therapy is defined as bilateral orchiectomy or gonadotropin- releasing hormone (GnRH) agonist with or without an antiandrogen.
• 4. Prior Treatment:
• * Hormone therapy at any point prior to 6 months before enrollment is prohibited. This includes any of the following treatments:
• * orchiectomy,
• * GnRH agonist (e. g., leuprolide, goserelin, triptorelin),
• * estrogen therapy,
• * antiandrogen (e. g., bicalutamide, flutamide, nilutamide), or
• * any other therapy known to lower testosterone level or inhibit testosterone effect.
• * Prior neoadjuvant and/or adjuvant hormone therapy is allowed provided that the duration of hormone therapy was six months or less and the hormone therapy was discontinued more than 6 months prior to study entry.
• * No prior treatment with a bisphosphonate
• * No prior treatment with denosumab
• * No prior treatment with radiopharmaceuticals
• * ≥ 4 weeks since completion of prior radiation therapy with at least one bone metastasis present that has NOT been radiated.
• 5. ECOG (CTC) performance status 0-2
• 6. Age: ≥ 18 years
• 7. Required Initial Laboratory Data:
• * Calculated Creatinine Clearance ≥ 30 mL/min
• * Corrected serum calcium ≥ 8.0 mg/dL (2.00 mmol/L) and \<11.6 mg/dL (2.90 mmol/L)