Phase III Trial of Enzalutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,311
- 试验地点
- 536
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.
详细描述
Patients are randomized to one of two treatment groups: enzalutamide or enzalutamide, abiraterone and prednisone. Treatment will continue until disease progression or unacceptable toxicity. Patients are followed for clinical outcomes for a maximum of 5 years post study treatment. The primary and secondary objectives are described below.
- Primary Objective:
To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer (CRPC) treated with either enzalutamide only or enzalutamide with abiraterone and prednisone 2. Secondary Objectives:
- To assess the grade 3 or higher toxicity profile and compare safety by treatment arm.
- To assess and compare post-treatment prostate-specific antigen (PSA) declines by treatment arm.
- To compare radiographic progression free survival defined by Prostate Cancer Working Group 2 (PCWG2), and objective response rate, by treatment arm.
- To test for radiographic progression free survival (rPFS) treatment interaction in predicting overall survival.
- To assess pre- and post-treatment measures of tumor burden and bone activity using sodium fluoride (NaF) positron emission tomography (PET)/computed tomography (CT) and technetium (Tc) methylene diphosphonate (MDP) bone scintigraphy and correlate these measures with overall survival.
- To develop and validate prognostic and predictive models of overall survival that include baseline clinical and molecular markers.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A: (enzalutamide)
Patients receive enzalutamide 160 mg PO QD. Treatment will continue until confirmed disease progression or unacceptable toxicity.
干预措施: enzalutamide (Drug)
Arm B: (enzalutamide, abiraterone, prednisone)
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
干预措施: enzalutamide (Drug)
Arm B: (enzalutamide, abiraterone, prednisone)
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
干预措施: abiraterone (Drug)
Arm B: (enzalutamide, abiraterone, prednisone)
Patients receive enzalutamide 160 mg PO QD, abiraterone 1000 mg PO QD, and prednisone 5 mg PO BID. Treatment will continue until confirmed disease progression or unacceptable toxicity.
干预措施: prednisone (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 5 years post treatment
Overall survival is defined as the time from study registration to death due to any cause.
次要结局
- Objective Response Rate(Up to 5 years post treatment)
- Number of Participants Who Has Experienced at Least One Toxicity (Defined as a Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment)(Up to 5 years post treatment)
- Decline in Prostate Specific Antigen (PSA)(Up to 5 years post treatment)
- Progression Free Survival (PFS)(Up to 5 years post treatment)
- Radiographic Progression Free Survival (rPFS)(Up to 5 years post treatment)
- Tumor Burden and Bone Activity(Up to 5 years post treatment)