The addition of zoledronic acid and celecoxib demonstrated a survival advantage for men with hormone therapy-naïve metastatic prostate cancer, while the addition of celecoxib alone to hormone therapy showed no survival advantage, according to a study presented at the 2016 Genitourinary Cancers Symposium.1

STAMPEDE is a randomized controlled trial consisting of multiple arms and multiple stages that evaluated different schedules of chemotherapy and hormone therapy in men with high-risk locally advanced or metastatic prostate cancer initiating long-term hormone therapy for the first time. It also evaluated the addition of celecoxib with or without zoledronic acid to hormone therapy.

For this portion of the trial, researchers enrolled 1245 men and randomly assigned them 2:1:1 to receive hormone therapy for at least 2 years, hormone therapy plus celecoxib 400 mg twice daily until 1 year, or hormone therapy plus celecoxib and zoledronic acid 4 mg for six 3-week cycles, then 4-week cycles until 2 years. Patients were also encouraged to receive radiotherapy if they had M0 disease.

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Results showed that at a median follow-up of 62 months, median overall survival was 68 months in the hormone therapy alone arm compared with 69 months in the hormone therapy plus celecoxib arm (HR, 1.00; 95% CI, 0.82 – 1.22; P = .99) and 74 months with celecoxib and zoledronic acid (HR, 0.86; 95% CI, 0.70 – 1.06; P = .16).

In pre-planned analyses in men with metastatic disease, researchers found that adding celecoxib and zoledronic acid to hormone therapy improved survival compared with hormone therapy alone (HR, 0.78; 95% CI, 0.62 – 0.99).

Celecoxib is a COX-2-selective nonsteroidal anti-inflammatory drug approved by the U.S. Food and Drug Administration for the treatment of patients with osteoarthritis, rheumatoid arthritis, acute pain, ankylosing spondylitis, and primary dysmenorrhea.


  1. James ND, Sydes MR, Clarke NW, et al. Celecoxib with or without zoledronic acid for hormone-naïve prostate cancer: survival results from STAMPEDE (NCT00268476). J Clin Oncol. 2016; 34 (suppl 2S; abstr 162).