Celecoxib With Or Without Zoledronic Acid For Hormone-Naive Prostate Cancer: Survival Results From Stampede (Nct00268476)

162 Background: STAMPEDE is a randomised controlled trial using a multi-arm multi-stage design. It recruits men (pts) with high-risk locally advanced or metastatic prostate cancer (PCa) starting long-term hormone therapy (HT) for the first time. The trial initially assessed adding one or two of three treatment approaches to standard-of-care (SOC). We report comparative survival data for the two original comparisons that stopped accrual early at pre-planned lack-of-activity analysis based on failure-free survival (FFS): celecoxib (Cox) and celecoxib + zoledronic acid (Cox+ZA). Methods: SOC was HT for at least 2yrs; RT was encouraged for men with M0 disease. Stratified randomisation allocated pts 2:1:1 to SOC (control), SOC+Cox or SOC+Cox+ZA. Celecoxib (400mg) was given twice daily until 1yr. Zoledronic acid (4mg) was given for six 3-weekly cycles then 4-weekly until 2yrs. The primary outcome measure was death from any cause. This pre-planned analysis is triggered by analysis of the “original comparisons” t...