DRKS00017467已完成3 期
Randomized multicenter, phase III trial evaluating the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (= 65years) with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen - CABASTY
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie (ARTIC)Georges Pompidou European Hospital0 个研究点目标入组 180 人开始时间: 2019年6月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 65 Years 至 one（—）
- 性别
- Male
入选标准
- •1. Patient aged = 65 years with mCRPC previously treated with docetaxel
- •2. Medical or surgical castration with castrate level of testosterone (< 50 ng/dl) based on the EAU definition of castrate level of testosterone
- •3. Progressive disease according to PCWG2 (Appendix H)
- •4. Histologically proven prostate carcinoma
- •5. Health status allowing use of chemotherapy: G8 > 14; or G8 score = 14 with geriatric assessment concluding to reversible impairment allowing use of chemotherapy
- •6. ECOG-PS 0, 1 or 2(ECOG-PS 2 should be related to prostate cancer)
- •7. Adequate hematologic, liver and renal functions:
- •a) Neutrophil count =1.5 109/L
- •b) Haemoglobin =10 g/ dL
- •c) Platelet count =100.109/L
- •d) Total bilirubin = 1 the upper limit of normal (ULN)
- •e) Transaminases = 1.5 ULN
- •f) Serum creatinine = 2.0 ULN
- •8. Ongoing LHRH therapy at study entry
- •9. Signed informed consent
排除标准
- •1. History of severe hypersensitivity reaction (=grade 3) to docetaxel
- •2. History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs
- •3. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- •4. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix E)
- •5. ECOG-PS >2 not related to prostate cancer disease
- •6. G8 = 14 with geriatric assessment contra-indicating standard cabazitaxel regimen
- •7. Concomitant vaccination with yellow fever vaccine
- •8. Patient who cannot be regularly followed or cannot answer to quality of life questionnaires because of psychological, social, familial or geographic reasons.
- •9. Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment.
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