NCT05983783招募中3 期
A Prospective Randomized Controlled Study Comparing the Efficacy and Safety of Rezvilutamide+ADT+Docetaxel Versus Rezvilutamide +ADT in the Treatment of Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- rPFS
研究概览
简要总结
Evaluate whether the combination of Rezvilutamide and androgen deprivation therapy (ADT) with docetaxel improves overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to the combination of Rezvilutamide and ADT.
详细描述
To investigate the value of chemotherapy in the treatment of high-burden of mHSPC on the background of next-genertion of AR inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged ≥40 years and ≤80 years.
- •Histologically or cytologically confirmed prostate adenocarcinoma.
- •Metastatic disease.
- •Eligible for ADT and Docetaxel.
- •Started or not started first-generation androgen deprivation therapy (ADT), but not exceeding 12 weeks before randomization.
- •ECOG score of 0 or
- •Laboratory tests meet the following requirements:
- •Hematology: neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥9g/dL.
- •Renal function: serum creatinine ≤1.5× upper limit of normal (ULN).
- •Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN, total bilirubin (TBIL) ≤1.5× ULN.
- •Coagulation function: international normalized ratio (INR) <1.
- •Study subjects: Patients with mHSPC have a confirmed pathology of prostate adenocarcinoma with high tumor burden, which is defined by having at least one of the following conditions:
- •Bone scan showing ≥4 bone metastatic lesions (with at least one site outside the pelvis or spine).
- •CT/MRI revealing visceral metastatic lesions (excluding lymph nodes).
排除标准
- •Patients who meet any of the following criteria are not eligible to participate in this study:
- •Prior use of LHRH agonists/antagonists; second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), or other investigational AR inhibitors; CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
- •Received radiation therapy/radiopharmaceutical treatment within 2 weeks before randomization.
- •Any of the following conditions within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV).
- •Previous malignancy, except adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or superficial bladder cancer not invading the deeper muscle layer (i.e., pTis, pTa, and pT1) and any other cancer in complete remission for at least 5 years before randomization.
- •Gastrointestinal diseases or procedures that are expected to significantly interfere with the absorption of study treatment.
- •Inability to take oral medication.
研究组 & 干预措施
Rezvilutamide+ADT+Docetaxel
Experimental
Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.
Docetaxel 6 cycles
干预措施: Docetaxel (Drug)
Rezvilutamide+ADT
Active Comparator
Rezvilutamide: 240 mg (3 tablets of 80 mg each) orally once daily (QD), can be taken with or without food.
干预措施: Rezvilutamide (Drug)
结局指标
主要结局
rPFS
时间窗: 36 months
radiographic Progression-Free Survival
次要结局
- prostate-specific antigen (PSA) response rate(36 months)
- time to castration-resistant prostate cancer (CRPC)(36 months)
研究者
Hua Lixin
M.D.
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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