2024-516939-28-00尚未招募2 期
A randomized phase II trial of docetaxel or cabazitaxel with or without darolutamide in men with metastatic castration-resistant prostate cancer.
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)16 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2024年10月28日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 245
- 试验地点
- 16
- 主要终点
- The main study endpoint is progression free survival, which is defined as time from randomization to radiologic, biochemical or pain progression or death from any cause, whichever occurs first, according to PCWG3 (Appendix C).
研究概览
简要总结
To compare progression free survival (PFS) between treatment with docetaxel or cabazitaxel and darolutamide versus treatment with docetaxel or cabazitaxel in mCRPC patients.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer Working Group (PCWG) 3 criteria), with an indication for docetaxel or cabazitaxel. Progression defined as ≥ 1 of the following 3 criteria: a. Radiographic disease progression in soft tissue per RECIST v1.1 b. Radiographic disease progression in bone defined by the appearance of ≥ 2 new bone lesions on bone scan. c. PSA progression defined as ≥ 2 sequential rises in PSA obtained ≥ 1 week apart with a minimal starting value of ≥ 1 ng/mL. A PSA value ≥ 2 ng/mL is required at study entry.
- •Patients should have had disease progression previously on at least one ARSi (abiraterone, apalutamide, darolutamide or enzalutamide). ARSi administration is allowed both in the mCNPC and in the mCRPC setting. Coadministration of docetaxel in mCNPC (triplet-therapy) is allowed.
- •WHO performance ≤ 2 (see appendix A)
- •Able and willing to sign the Informed Consent Form prior to screening evaluations
- •Adequate haematological, renal and liver function and chemistry, defined as: a. Hemoglobin ≥ 6.0 mmol/L b. Platelets ≥ 100 x 109/L c. ALT/AST ≤ 3x ULN and ≤ 5x ULN in case of liver metastases d. Creatinine clearance ≥ 50 ml/min e. Serum testosterone ≤ 1.7 nmol/L
排除标准
- •Impossibility or unwillingness to take oral drugs
- •Hypersensitivity to taxanes
- •Known serious illness or medical unstable conditions that could interfere with this study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster, organ transplants, kidney failure, serious liver disease (e.g. severe cirrhosis), cardiac and respiratory diseases)
- •Symptomatic peripheral neuropathy CTCAE grade ≥2
- •Docetaxel-rechallenge.
结局指标
主要结局
The main study endpoint is progression free survival, which is defined as time from randomization to radiologic, biochemical or pain progression or death from any cause, whichever occurs first, according to PCWG3 (Appendix C).
The main study endpoint is progression free survival, which is defined as time from randomization to radiologic, biochemical or pain progression or death from any cause, whichever occurs first, according to PCWG3 (Appendix C).
次要结局
- Overall survival, defined as time from randomization to death from any cause.
- Time to progression, defined as time from randomization to radiologic, biochemical or pain progression, whichever occurs first.
- The time to PSA progression, defined as time from randomization to biochemical progression.
- The time to pain progression, defined as time from randomization to pain progression.
- The number and severity of adverse events
- Cell-free DNA aneuploidy scores and somatic aberrations in circulating tumor DNA
- Differential expression of relevant genes, as measured in tissue and liquid biopsies. (comparing tissue and liquid biopsies at baseline and on-treatmen
- Immune subset phenotyping and subtyping as measured in tissue and whole blood
研究者
Prof. R.H.J. Mathijssen
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (16)
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