A Multi-center, Single Arm Study of Enzalutamide in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 50
- 主要终点
- Radiographic Progression-free Survival (rPFS)
研究概览
简要总结
The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment in patients with progressive metastatic castration-resistant prostate cancer previously treated with abiraterone acetate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject has histologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentiation or small cell features.
- •Subject has metastatic disease documented by bone scan or by soft tissue disease observed by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) at screening, or within ≤30 days prior to Day
- •In the setting of castrate levels of testosterone ≤1.7 nmol/L (or ≤50 ng/dL), subject has progressive disease at study entry defined as PSA rise determined by a minimum of 2 rising PSA levels with an interval of ≥ 1 week between each assessment. The PSA value at the screening visit should be ≥ 2 ng/mL WITH or WITHOUT:
- •Soft tissue disease progression defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) at screening, or within ≤30 days prior to Day
- •Measurable disease is not required for entry. Lymph nodes ≥ 2 cm are considered measurable disease (Prostate Cancer Clinical Trials Working Group (PCWG2)).
- •Bone disease progression defined by at least 2 new lesions on bone scan at screening, or within ≤30 days prior to Day
- •Subject must have received a minimum of 24 weeks of treatment with abiraterone acetate within its approved label indication and has discontinued use at least 4 weeks prior to start of study drug at Day
- •If the subject has received previous treatment with chemotherapy for prostate cancer, this must be limited to no more than one prior line of docetaxel, and must have been used prior to abiraterone acetate therapy.
- •Subject receives and will continue to receive ongoing androgen deprivation with Luteinizing-hormone-releasing hormone (LHRH) analogue therapy throughout the course of the study or has had a bilateral orchiectomy.
- •Subject is asymptomatic or mildly symptomatic from prostate cancer:
- •The score on Brief Pain Inventory - Short Form (BPI-SF) Question #3 must be <
- •No use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to screening.
排除标准
- •Subject has prior use of ketoconazole for the treatment of prostate cancer.
- •Subject has prior use of cabazitaxel.
- •Subject has prior use of enzalutamide.
- •Subject has received ANY anti-neoplastic therapy (including antiandrogens and chemotherapy) following abiraterone acetate discontinuation and prior to start of study drug at Day
- •Subject has a known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
- •Subject has known or suspected brain metastases or active leptomeningeal disease.
- •Subject has history of seizure or any condition that may predispose to seizure (e.g., prior stroke or significant brain trauma).
研究组 & 干预措施
Enzalutamide
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Radiographic Progression-free Survival (rPFS)
时间窗: From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months.
Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer \& Crowley (BC) method.
次要结局
- Overall Survival (OS)(From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years.)
- Percentage of Participants With a Prostate-specific Antigen (PSA) Response(From the first dose of study drug administration up to the data cut-off date for end-of-study completion 29 Sep 2017; the median duration of treatment was 5.7 months.)
- Time to PSA Progression(From the first dose of study drug administration up to the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months.)
- Number of Participants With Adverse Events (AEs)(From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.)