Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Brief Summary: The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer


Options:
A: 1. Histologic Documentation: Histologic documentation of prostate adenocarcinoma. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.
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.
   * Patients treated with intermittent androgen deprivation therapy are not eligible except for patients concurrently enrolled in SWOG-9346/INT-0162/CALGB 9594, Phase III Study of Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer.
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)
B: Other criteria also apply
C: Inclusion Criteria:

* Men \>/= 18 years of age with histologically confirmed prostate cancer
* Radiographic evidence of at least one bone metastasis
* Failure of at least one hormonal therapy as evidenced by a rising PSA
* Serum testosterone level of \<50 ng/dL
* ECOG PS 0, 1, or 2
* Adequate organ function

Exclusion Criteria:

* Current or prior IV bisphosphonate administration
* Current or prior oral bisphosphonates for bone mets
* Life expectancy of less than 6 months
D: Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic bone disease (by CT, MRI or bone scan) with plans to start or be \< 30 days from beginning androgen deprivation therapy. Patients with lymph node or visceral metastases only are not eligible
* Patients may receive palliative radiation therapy at the investigators discretion during the first 4 weeks of beginning protocol therapy.

Exclusion Criteria:

* No neuroendocrine, small cell or transitional cell cancer of the prostate No abnormal bone metabolism (i.e., Paget's disease, untreated hyperthyroidism, untreated hyperprolactinemia, untreated Cushing's disease).
* No use of calcitonin within 14 days before being registered for protocol therapy or any previous use of bisphosphonates.
* No major surgery within 4 weeks of registration to protocol therapy.
* No adjuvant chemotherapy within 6 months of registration to protocol therapy.
* No previous chemotherapy for metastatic disease.
* No hormonal therapy in the adjuvant setting within 12 months of registration to protocol therapy; previous hormonal therapy must not have exceeded 6 months.
* No prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin.
* No history of allergy or drug reactions to bisphosphonates.

Answer: C