#Mitoza good ending trial#

Cost-effectiveness was assessed from the NHS perspective and expressed as cost per additional quality-adjusted life-year (QALY). Log-rank test and Cox regression modelling were used to determine clinical effectiveness. Secondary outcomes were SRE-free interval (SREFI), total SREs, overall survival (OS) and quality of life (QoL). Primary outcomes were clinical progression-free survival (CPFS: time to pain progression, SRE or death) and cost-effectiveness. Patients were randomised to receive six cycles of docetaxel plus prednisolone: alone, with ZA, with a single Sr-89 dose after cycle 6, or with both. TRAPEZE aimed to determine the clinical effectiveness and cost-effectiveness of each agent. Phase II analysis confirmed the safety and feasibility of combining these agents. Sr-89, approved for controlling metastatic pain and reducing need for subsequent bone treatments, is generally palliatively used in patients unfit for chemotherapy. ZA, approved on the basis of reducing skeletal-related events (SREs), is commonly combined with docetaxel in practice, although evidence of efficacy and cost-effectiveness is lacking. All have palliative benefits, are used to control bone symptoms and are used with docetaxel to prolong survival.

#Mitoza good ending trial#

TRAPEZE was a two-by-two factorial randomised controlled trial of zoledronic acid (ZA) and strontium-89 (Sr-89), each combined with docetaxel. Bony metastatic castration-refractory prostate cancer is associated with a poor prognosis and high morbidity.