• Malcolm D Mason, Noel W Clarke, Nicholas D James, David P Dearnaley, Melissa R Spears, Ritchie Alastair W S AWS Malcolm D. Mason, Cardiff University School of Medicine, Velindre Hospital; Jim Barber, Velindre Cancer Centre, Cardiff; Noel W. Clarke, The Chri, Gerhardt Attard, William Cross, Rob J Jones, Christopher C Parker, J Martin Russell, George N Thalmann, Francesca Schiavone, Estelle Cassoly, David Matheson, Robin Millman, Cyrill A Rentsch, Jim Barber, Clare Gilson, Azman Ibrahim, John Logue, Anna Lydon, Ashok D Nikapota, Joe M O'Sullivan, Emilio Porfiri, Andrew Protheroe, Narayanan Nair Srihari, David Tsang, John Wagstaff, Jan Wallace, Catherine Walmsley, Parmar Mahesh K B MKB Malcolm D. Mason, Cardiff University School of Medicine, Velindre Hospital; Jim Barber, Velindre Cancer Centre, Cardiff; Noel W. Clarke, The Christi, Matthew R Sydes, and STAMPEDE Investigators.
• 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, Gerhardt Attard, and Christopher C. Parker, The Institute of Cancer Research and Royal Marsden NHS Foundation Trust; Melissa R. Spears, Alastair W.S. Ritchie, Francesca Schiavone, David Matheson, Robin Millman, Clare Gilson, Mahesh K.B. Parmar, and Matthew R. Sydes, MRC Clinical Trials Unit at UCL, London; William Cross, Leeds Teaching Hospitals NHS Trust, Leeds; Rob J. Jones and J. Martin Russell, University of Glasgow; Rob J. Jones and Jan Wallace, Beatson West of Scotland Cancer Centre, Glasgow; Azman Ibrahim, The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral; Anna Lydon, Torbay District Hospital, Torquay; Ashok D. Nikapota, Sussex Cancer Centre, Brighton; Ashok D. Nikapota, Worthing Hospital, Worthing; Joe M. O'Sullivan, Centre for Cancer Research and Cell Biology, Queen's University, Belfast; Andrew Protheroe, Churchill Hospital, Oxford; Narayanan Nair Srihari, Shrewsbury and Telford Hospitals NHS Trust, Shrewsbury; David Tsang, Southend Hospital, Southend-on-Sea; David Tsang, Basildon Hospital, Basildon; John Wagstaff, The South West Wales Cancer Institute; John Wagstaff, Swansea University College of Medicine, Swansea; Catherine Walmsley, Royal Preston Hospital, Preston, United Kingdom; George N. Thalmann, University Hospital; Estelle Cassoly, SAKK Coordinating Center, Berne; and Cyrill A. Rentsch, University Hospital Basel, Basel, Switzerland.
• J. Clin. Oncol. 2017 May 10; 35 (14): 1530-1541.

AbstractPurpose 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. Patients and Methods Standard of care (SOC) was hormone therapy continuously (metastatic) or for ≥ 2 years (nonmetastatic); prostate (± 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. Results 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. Conclusion These data show no overall evidence of improved survival with Cel. Preplanned subgroup analyses provide hypotheses for future studies.

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