A Randomised Phase III Trial Of Low Dose DailyDexamethasone Versus Intermittent Dexamethasone Versus Prednisolone In Hormone Refractory Prostate Cancer - PoD trial
- Conditions
- Hormone refractory prostate cancer
- Registration Number
- EUCTR2005-006018-16-GB
- Lead Sponsor
- Royal Marsden Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
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 < 2 nmol/l. Ongoing androgen deprivation therapy with LHRH analogues or bilateral orchidectomy.
Progressive disease defined as a PSA rise using 3 serum PSA measurements, each obtained at least 7 days apart within the 3 months prior to start of trial. Patients who were withdrawn from anti-androgen therapy less than 6 weeks prior to inclusion in the study also require one PSA higher than the last pre-withdrawal PSA or 2 increases in PSA documented after the post-withdrawal nadir ? 4 weeks from treatment withdrawal if treated with flutamide and ? 6 weeks if treated with bicalutamide or nilutamide. Patients with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression.
PSA > 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method