Hormone refractory prostate cancer
Conditions
Interventions
Trade Name: PREDNISOLONE
Product Name: Prednisolone
Product Code: Prednisolone
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISO
Sponsors
Royal Marsden Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate or sclerotic bone metastases/increased tracer uptake on bone scan in a patient presenting with a PSA>100. Serum testosterone 5 Life expectancy over 3 months. Stable/optimum analgesia ECOG performance status 0-3 Written, informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: External beam radiotherapy, brachytherapy or cryotherapy within 4 weeks of start of study. Patients with serious or uncontrolled co-existent non-malignant diseases. Active or uncontrolled infection. History of untreated peptic ulcer disease Treatment with any investigational compound within 30 days Any previous treatment with steroids for prostate cancer, (steroids given accompanying cytotoxic chemotherapy are permitted) Any of the following treatment in the last 4 weeks: Anti androgen, oestrogen, radioisotopes, chemotherapy Inability to comply with pain scores and QOL assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To evaluate the PSA response rate of low dose dexamethasone and of intermittent dexamethasone in patients with hormone refractory prostate cancer. ; Secondary Objective: • To evaluate the clinical and biochemical parameters which influence PSA response to oral steroids in HRPC. • To evaluate the effect of dexamethasone on duration of PSA response in HRPC • To evaluate the effect of dexamethasone on time to PSA progression in HRPC • To evaluate the effect of dexamethasone on objective response using RECIST criteria in HRPC • To evaluate the effect of dexamethasone on pain control and time to skeletal events in HRPC • To evaluate the effect of dexamethasone on alkaline phosphatase and haemoglobin in HRPC • To evaluate the safety and tolerability of dexamethasone in HRPC • To evaluate the effect of dexamethasone on overall survival in HRPC ; Primary end point(s): PSA response (PSAWG criteria) | — |
Countries
United Kingdom
Outcome results
None listed