Phase II study of zoledronic acid concomitant with androgen deprivation therapy for patients with treatment-naive bone-metastatic prostate cancer

INTERVENTION: Bicalutamide (AstraZeneca, Tokyo, Japan) 80mg administered orally on Day 1 and every day, goserelin acetate (AstraZeneca, Tokyo, Japan) 10.8mg administered subcutaneously on Day 8 and every 12 weeks, and zoledronic acid (Novartis Pharma, Tokyo, Japan) 4mg administered intravenously on Day 8 and every 4 weeks. Zoledronic acid was continued as long as 24 months regardless of disease progression. CONDITION: Prostate cancer PRIMARY OUTCOME: Skeleton‐related event‐free survival at 24 month after the introduction of treatment SECONDARY OUTCOME: Progression‐free survival, time to first SRE, overall survival, decrease of the extent of bone diseases, improvement of pain, and safety INCLUSION CRITERIA: Treatment‐naive male patients with histologically confirmed adenocarcinoma of the prostate. Radiologic evidence of bone metastasis. Eastern Cooperative Oncology Group performance status of 0 or 1. Adequate bone marrow, hepatic, and renal function: White blood cell count >4.0x103/mm3 Platelet count >100x103/ mm3 Hemoglobin >10.0 g/dL Serum bilirubin <1.5 times the upper limit of normal Aspartate and alanine aminotransferase levels <2.5 times the ULN Creatinine clearance >60mL/min ECOG performance status of 2 due to bone disease was permitted.