A multicentre, phase II randomised controlled trial evaluating cabazitaxel versus docetaxel re-challenge for the treatment of metastatic Castrate Refractory Prostate Cancer, previously treated with docetaxel at inception of primary hormone therapy - Cabazitaxel versus docetaxel re-challenge for mCRPC (CANTATA)

niversity of Birmingham0 个研究点目标入组 15 人开始时间: 2012年11月26日最近更新: 2020年7月27日

试验速览

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•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

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