A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,088
- 主要终点
- Overall Survival
研究概览
简要总结
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).
详细描述
This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 1,000 medically or surgically castrated male patients with metastatic CRPC who have shown tumor progression and are asymptomatic or mildly symptomatic. The study period will consist of screening, treatment, and follow-up phases. Patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until radiographic progression of disease and/or unequivocal clinical progression. Efficacy evaluations will be performed throughout the treatment period and safety will be assessed until 30 days after the last dose of abiraterone acetate. throughout the study. Follow-up will continue for up to 60 months (5 years) or until the patient dies, is lost to follow-up, or withdraws informed consent. At the interim analysis of overall survival (OS; 43% of death events), the independent data monitoring committee (IDMC) reviewed the efficacy and safety data and concluded that all of the data pointed to a significant advantage for patients in one arm of the study compared with the other arm thereby unanimously recommending unblinding the study and allowing crossover from the placebo arm to active therapy. Patients currently receiving placebo will be offered crossover therapy to abiraterone acetate. Treatment for patients who were originally randomized to the abiraterone acetate treatment group will not change. Patients will be discontinued from long term follow-up at the time of the Clinical Cut-Off Date for Final Analysis (CCO-FA); however, patients still receiving treatment with abiraterone acetate at the CCO-FA will be offered to receive continued treatment for an additional period of up to 3 years or until disease progression or unacceptable toxicity. For these patients, safety assessment will be performed while continuing treatment, and for 30 days after the last dose of abiraterone acetate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Metastatic castration-resistant prostate cancer (CRPC)
- •Previous anti-androgen therapy and progression after withdrawal
- •ECOG performance status of either 0 or 1
- •Medical or surgical castration with testosterone less than 50 ng/dL
- •Life expectancy of at least 6 months
排除标准
- •Prior cytotoxic chemotherapy or biologic therapy for CRPC
- •Prior ketoconazole for prostate cancer
- •Known brain metastasis or visceral organ metastasis
- •Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
研究组 & 干预措施
Placebo + prednisone
Placebo plus prednisone
干预措施: Placebo (Drug)
Placebo + prednisone
Placebo plus prednisone
干预措施: Prednisone (Drug)
Abiraterone + prednisone
Abiraterone acetate plus prednisone
干预措施: Abiraterone acetate (Drug)
Abiraterone + prednisone
Abiraterone acetate plus prednisone
干预措施: Prednisone (Drug)
结局指标
主要结局
Overall Survival
时间窗: From randomization (Day 1) up to end of study (Month 60)
Overall survival is defined as the time from randomization to date of death from any cause.
Radiographic Progression-free Survival (rPFS)
时间窗: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
次要结局
- Maximum Plasma Concentrations of Abiraterone(Up to Cycle 5, Day 1)
- Time to Opiate Use for Prostate Cancer Pain(From randomization (Day 1) up to first opiate use or end of study (Month 60))
- Time to Initiation of Cytotoxic Chemotherapy(From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18))
- Mean Plasma Concentrations of Abiraterone(Up to Cycle 5, Day 1)
- Number of Participants With Treatment Emergent Adverse Events(From first dose of study drug up to 30 days after the last dose of study drug)
- Elimination Half-Life (t1/2)(Up to Cycle 5, Day 1)
- Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point(From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18))
- Time to Prostate-specific Antigen (PSA) Progression(From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18))
- Area Under the Plasma Concentration-time Curve From Time 0 to Time the Last Quantifiable Concentration of Abiraterone (AUC[0-infinity])(Up to Cycle 5, Day 1)