{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T20:05:54Z","timestamp":1787601954240,"version":"build-2736575974"},"reference-count":27,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"14","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2017,5,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy. We report survival data for two celecoxib (Cel)-containing comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Standard of care (SOC) was hormone therapy continuously (metastatic) or for \u2265 2 years (nonmetastatic); prostate (\u00b1 pelvic node) radiotherapy was encouraged for men without metastases. Cel 400 mg was administered twice a day for 1 year. Zoledronic acid (ZA) 4 mg was administered for six 3-weekly cycles, then 4-weekly for 2 years. Stratified random assignment allocated patients 2:1:1 to SOC (control), SOC + Cel, or SOC + ZA + Cel. The primary outcome measure was all-cause mortality. Results were analyzed with Cox proportional hazards and flexible parametric models adjusted for stratification factors. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> A total of 1,245 men were randomly assigned (Oct 2005 to April 2011). Groups were balanced: median age, 65 years; 61% metastatic, 14% N+\/X M0, 25% N0M0; 94% newly diagnosed; median prostate-specific antigen, 66 ng\/mL. Median follow-up was 69 months. Grade 3 to 5 adverse events were seen in 36% SOC-only, 33% SOC + Cel, and 32% SOC + ZA + Cel patients. There were 303 control arm deaths (83% prostate cancer), and median survival was 66 months. Compared with SOC, the adjusted hazard ratio was 0.98 (95% CI, 0.80 to 1.20; P = .847; median survival, 70 months) for SOC + Cel and 0.86 (95% CI, 0.70 to 1.05; P =.130; median survival, 76 months) for SOC + ZA + Cel. Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 (95% CI, 0.62 to 0.98; P = .033) for SOC + ZA + Cel. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> These data show no overall evidence of improved survival with Cel. Preplanned subgroup analyses provide hypotheses for future studies. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2016.69.0677","type":"journal-article","created":{"date-parts":[[2017,4,5]],"date-time":"2017-04-05T09:51:55Z","timestamp":1491385915000},"page":"1530-1541","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":58,"title":["Adding Celecoxib With or Without Zoledronic Acid for Hormone-Na\u00efve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial"],"prefix":"10.1200","volume":"35","author":[{"given":"Malcolm D.","family":"Mason","sequence":"first","affiliation":[{"name":"Malcolm D. Mason, Cardiff University School of Medicine, Velindre Hospital; Jim Barber, Velindre Cancer Centre, Cardiff; Noel W. Clarke, The Christie and Salford Royal NHS Foundation Trusts; John Logue, Christie Hospital, Manchester; Nicholas D. James, Institute of Cancer and Genomic Sciences; Emilio Porfiri, The Medical School, University of Birmingham; Nicholas D. James, Queen Elizabeth Hospital; Emilio Porfiri, University Hospitals Birmingham NHS Foundation Trust, Birmingham; David P. Dearnaley,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noel W.","family":"Clarke","sequence":"additional","affiliation":[{"name":"Malcolm D. Mason, Cardiff University School of Medicine, Velindre Hospital; Jim Barber, Velindre Cancer Centre, Cardiff; Noel W. Clarke, The Christie and Salford Royal NHS Foundation Trusts; John Logue, Christie Hospital, Manchester; Nicholas D. James, Institute of Cancer and Genomic Sciences; Emilio Porfiri, The Medical School, University of Birmingham; Nicholas D. James, Queen Elizabeth Hospital; Emilio Porfiri, University Hospitals Birmingham NHS Foundation Trust, Birmingham; David P. 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Clarke, The Christie and Salford Royal NHS Foundation Trusts; John Logue, Christie Hospital, Manchester; Nicholas D. James, Institute of Cancer and Genomic Sciences; Emilio Porfiri, The Medical School, University of Birmingham; Nicholas D. James, Queen Elizabeth Hospital; Emilio Porfiri, University Hospitals Birmingham NHS Foundation Trust, Birmingham; David P. Dearnaley,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa R.","family":"Spears","sequence":"additional","affiliation":[{"name":"Malcolm D. Mason, Cardiff University School of Medicine, Velindre Hospital; Jim Barber, Velindre Cancer Centre, Cardiff; Noel W. Clarke, The Christie and Salford Royal NHS Foundation Trusts; John Logue, Christie Hospital, Manchester; Nicholas D. James, Institute of Cancer and Genomic Sciences; Emilio Porfiri, The Medical School, University of Birmingham; Nicholas D. 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