Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase II Randomized Study of High-Dose Ketoconazole With or Without Alendronate Sodium in Patients With Androgen-Independent Metastastic Adenocarinoma of the Prostate
Brief Summary: RATIONALE: Ketoconazole may suppress the production of hormones and may interfere in the growth of prostate cancer cells. Alendronate sodium may be effective in preventing bone metastases and bone pain associated with prostate cancer. It is not known if ketoconazole is more effective with or without alendronate sodium.

PURPOSE: Randomized phase II trial to study the effectiveness of ketoconazole with or without alendronate sodium in treating patients who have metastatic prostate cancer.


Options:
A: Intervention Type: DRUG; Name: alendronate sodium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: ketoconazole; Assigned to Arm(s): N/A
B: Arm Label: IV Bisphosphonates q 4 weeks; Type: ACTIVE_COMPARATOR; Interventions: Drug: IV Bisphosphonate q 4 weeks | Arm Label: 180 mg AMG 162 (SC) q 12 weeks; Type: EXPERIMENTAL; Interventions: Genetic: AMG 162 180 mg (SC) q 12 weeks | Arm Label: 180 mg AMG 162 (SC) q 4 weeks; Type: EXPERIMENTAL; Interventions: Genetic: AMG 162- 180 mg q 4 weeks | Intervention Type: GENETIC; Name: AMG 162 180 mg (SC) q 12 weeks; Assigned to Arm(s): 180 mg AMG 162 (SC) q 12 weeks | Intervention Type: DRUG; Name: IV Bisphosphonate q 4 weeks; Assigned to Arm(s): IV Bisphosphonates q 4 weeks | Intervention Type: GENETIC; Name: AMG 162- 180 mg q 4 weeks; Assigned to Arm(s): 180 mg AMG 162 (SC) q 4 weeks
C: Arm Label: Zoledronic acid + androgen deprivation therapy; Type: EXPERIMENTAL; Interventions: Drug: zoledronic acid, Drug: androgen deprivation therapy, Drug: GnRH agonist, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D | Arm Label: Placebo + androgen deprivation therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: placebo, Drug: androgen deprivation therapy, Drug: GnRH agonist, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin D | Intervention Type: DRUG; Name: zoledronic acid; Assigned to Arm(s): Zoledronic acid + androgen deprivation therapy | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Placebo + androgen deprivation therapy | Intervention Type: DRUG; Name: androgen deprivation therapy; Assigned to Arm(s): Placebo + androgen deprivation therapy, Zoledronic acid + androgen deprivation therapy | Intervention Type: DRUG; Name: GnRH agonist; Assigned to Arm(s): Placebo + androgen deprivation therapy, Zoledronic acid + androgen deprivation therapy | Intervention Type: DIETARY_SUPPLEMENT; Name: Calcium supplement; Assigned to Arm(s): Placebo + androgen deprivation therapy, Zoledronic acid + androgen deprivation therapy | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D; Assigned to Arm(s): Placebo + androgen deprivation therapy, Zoledronic acid + androgen deprivation therapy
D: Arm Label: Arm I; Type: EXPERIMENTAL; Interventions: Drug: antiandrogen therapy, Drug: zoledronic acid | Arm Label: Arm II; Type: ACTIVE_COMPARATOR; Interventions: Drug: antiandrogen therapy | Intervention Type: DRUG; Name: antiandrogen therapy; Assigned to Arm(s): Arm I, Arm II | Intervention Type: DRUG; Name: zoledronic acid; Assigned to Arm(s): Arm I

Answer: A