NCT07241416招募中3 期
A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Study of Rezvilutamide Combined With Androgen Deprivation Therapy (ADT) Versus Enzalutamide Combined With ADT for Treating Low-volume Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Prostate Specific Antigen (PSA) undetectable rate based on central laboratory.
研究概览
简要总结
This study aims to compare the efficacy and safety of rezvilutamide with enzalutamide in the treatment of patients with low-volume metastatic hormone sensitive prostate cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participates in this clinical trial, with an understanding of the study procedures and signed informed consent;
- •Age ≥ 18 years;
- •Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine differentiation or small cell features;
- •Metastatic hormone sensitive prostate cancer;
- •ECOG PS: 0-1;
- •Planned to receive and maintain ADT during the study period;
- •Adequate hepatic, renal, heart, and hematological functions;
- •Determined by the investigator to be able to comply with the study protocol;
- •Fertile subjects must use effective contraception or abstain from sexual activity and sperm donation until 3 months after last exposure to rezvilutamide or enzalutamide. Subjects must use condoms plus an additional effective contraceptive method during sexual activity with a fertile female partner throughout treatment and for 3 months post-treatment.
排除标准
- •Prior treatment with ADT, chemotherapy, surgery, external-beam radiotherapy, brachytherapy, radiopharmaceuticals, or investigational local therapy for metastatic prostate cancer, except as specifically allowed by the protocol;
- •Previous use of second-generation androgen receptor antagonists, ketoconazole, abiraterone acetate, or other investigational drugs inhibiting androgen synthesis for prostate cancer treatment; or plans to use any second-generation androgen receptor antagonist other than the study drug during the study treatment period;
- •Total PSA has decreased to undetectable levels at baseline;
- •Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks before randomization: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels;
- •Planned to initiate any other anti-tumor therapies during the study;
- •Known history of hypersensitivity to rezvilutamide, enzalutamide, or any of their components;
- •Unable to swallow, chronic diarrhea or intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption;
- •History of seizure or certain conditions that may predispose to seizure;
- •Presence of clinically significant cardiovascular diseases within 6 months prior to randomization;
- •Any other malignancy within 5 years prior to randomization (except as specifically allowed by the protocol);
- •Active HBV or HCV infection;
- •History of immunodeficiency (including HIV-positive status, other acquired or congenital immunodeficiency disorders) or organ transplantation;
- •Any concomitant condition that, in the opinion of the investigator, would seriously jeopardize patient safety, confound study findings, or compromise the patient's ability to complete the study (e.g., hypertension inadequately controlled despite medication, severe diabetes, neurologic or psychiatric disorders, etc.) or any other circumstance.
研究组 & 干预措施
Enzalutamide Soft Capsules Group
Active Comparator
干预措施: Enzalutamide Soft Capsules (Drug)
Rezvilutamide Tablets Group
Experimental
干预措施: Rezvilutamide Tablets (Drug)
结局指标
主要结局
Prostate Specific Antigen (PSA) undetectable rate based on central laboratory.
时间窗: 6 months after randomization.
Defined as the proportion of subjects with a total PSA level below 0.2 ng/mL in central laboratory testing within 6 months after randomization.
次要结局
- PSA response rate based on local laboratory.(Up to approximately 5 years.)
- PSA undetectable rate based on local laboratory.(6 months after randomization.)
- Objective response rate (ORR).(Up to approximately 5 years.)
- Radiographic progression-free survival (rPFS).(Up to approximately 5 years.)
- Time to PSA progression based on local laboratory.(Up to approximately 5 years.)
- Time to castration-resistant prostate cancer (CRPC).(Up to approximately 5 years.)
- Overall survival (OS).(Up to approximately 5 years.)
- Adverse events (AEs).(Up to approximately 5 years.)
研究者
研究点 (2)
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