CANTATA: Chemotherapy comparison in relapsing Prostate Cancer that has spread
- Conditions
- Metastatic Castrate Refractory Prostate CancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003835-40-GB
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 15
1. Diagnosis of histologically proven prostate adenocarcinoma, that is castrate refractory 2. Previously treated with up to 6 cycles of Docetaxel at the same time (defined as commencing within 3 months) as instigation of primary hormone therapy. 3. Confirmed biochemical, radiological or clinical progression. 4. Metastatic disease 5. Aged 18 or over 6. WHO performance status grade 0 to 2 7. Adequate organ function as evidenced by: --ANC >1.5 x109/L --WBC >3.0 x109/L --Haemoglobin >10g/dL --Platelet count >100,000/mm3 --Total bilirubin <1.5 xULN --AST/ALT <1.5 xULN --GFR >30ml/min (calculated by EDTA clearance, 24h urine collection, or Cockcroft-Gault) --Available for long-term follow up --Patient’s written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98
1. Prior systemic therapy with other chemotherapy drugs 2. Metastatic brain disease or leptomeningeal disease 3. Previous extensive palliative radiotherapy to bone marrow, e.g. hemibody radiotherapy 4. Active grade =2 peripheral neuropathy (NCI CTC v 4) 5. Active infection requiring systemic antibiotic or anti-fungal medication 6. Patients with reproductive potential not implementing accepted and effective method of contraception
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