Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University Hospital Birmingham
OBJECTIVES: Primary * To assess the toxicity and tolerability of docetaxel with zoledronic acid. * To assess the toxicity and tolerability of docetaxel with strontium chloride Sr 89. * To assess the toxicity and tolerability of docetaxel with zoledronic acid and strontium chloride Sr 89. Secondary * Compare health economic endpoints between the treatment groups. * Compare changes in bone mineral density between the treatment groups. * Compare the biological profiling for prognostic and predictive indicators between the treatment groups. Tertiary * Compare median time to disease progression between the treatment groups. * Compare pain progression-free survival (PFS) between the treatment groups. * Compare PSA PFS between the treatment groups. * Compare pain response between the treatment groups. * Compare overall survival between the treatment groups. * Compare quality of life between the treatment groups. OUTLINE: This is a multicenter study. Patients are stratified according to treatment center and ECOG performance status (0 vs 1 vs 2). Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive docetaxel IV on day 1 and oral prednisolone once daily. * Arm II: Patients receive docetaxel and prednisolone as in arm I and zoledronic acid IV over 15 minutes on day 1. * Arm III: Patients receive docetaxel and prednisolone as in arm I and a single dose of strontium chloride Sr 89 IV on day 7 of course 2. * Arm IV: Patients receive docetaxel and prednisolone as in arm I, zoledronic acid as in arm II, and strontium chloride Sr 89 as in arm III. Treatment with docetaxel, prednisolone, and zoledronic acid repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Strontium chloride Sr 89 is given as a one time single dose. Quality of life is assessed using the Euroqual (EQ-5D) and FACT-P at baseline and every 3 months during follow up. After completion of study, patients are followed every 3 months. Peer Reviewed and Funded or Endorsed by Cancer Research UK
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
