Journal article
Clinical outcomes and survival following treatment of metastatic castrate-refractory prostate cancer with docetaxel alone or with strontium-89, zoledronic acid, or both: The TRAPEZE randomized clinical trial
ND James, SJ Pirrie, AM Pope, D Barton, L Andronis, I Goranitis, S Collins, A Daunton, D McLaren, J O'Sullivan, C Parker, E Porfiri, J Staffurth, A Stanley, J Wylie, S Beesley, A Birtle, J Brown, P Chakraborti, S Hussain Show all
JAMA Oncology | AMER MEDICAL ASSOC | Published : 2016
Abstract
Importance: Bonymetastatic castrate-refractory prostate cancer (CRPC) has a poor prognosis and high morbidity. Zoledronic acid (ZA) is commonly combined with docetaxel in practice but lacks evidence that combining is effective, and strontium-89 (Sr89) is generally used palliatively in patients unfit for chemotherapy. Phase 2 analysis of the TRAPEZE trial confirmed combining the agents was safe and feasible, and the objectives of phase 3 include assessment of the treatments on survival. Objective: To determine clinical effectiveness and cost-effectiveness of combining docetaxel, ZA, and Sr89, all having palliative benefits and used in bonymetastatic CRPC to control bone symptoms and, for doce..
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Awarded by UK National Institute for Health Research Health Technology Assessment Programme (NIHR HTA)
Funding Acknowledgements
Sanofi Aventis and Novartis Pharmaceuticals supported the trial with educational grants and support for drug costs or trial discount for sites, respectively, and GE Healthcare also offered a trial discount to sites purchasing strontium-89. The TRAPEZE trial was an independent research project commissioned and funded by the UK National Institute for Health Research Health Technology Assessment Programme (NIHR HTA No. 06/303/205). The NIHR HTA will publish the full trial results in the Health Technology Assessment journal later in 2015; the NIHR HTA encourages publication of trial results journals but was not involved in the decision to do so here.