A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) 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
- 313
- 主要终点
- Time to prostate specific antigen (PSA) progression (TTPP)
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).
详细描述
This is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. All patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). The study will consist of a screening phase (within 28 days prior randomization on Cycle 1, Day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to Month 60, focusing primarily on survival status). Patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily.
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
- •Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease
- •Prostate cancer progression documented by PSA progression or radiographic progression
- •Asymptomatic or mildly symptomatic from prostate cancer
- •Surgically or medically castrated, with testosterone levels of <50 ng/dL
- •Previous anti-androgen therapy and progression after withdrawal
- •ECOG performance status score of 0 or 1
- •If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1
- •If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1
- •If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days
- •Life expectancy of at least 6 months
排除标准
- •Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated
- •Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily
- •Pathological finding consistent with small cell carcinoma of the prostate
- •Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months
- •Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
- •Radiation or radionuclide therapy for treatment of mCRPC
- •Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment
- •History of pituitary or adrenal dysfunction
研究组 & 干预措施
Abiraterone acetate and prednisone
干预措施: Abiraterone acetate and prednisone (Drug)
Placebo and prednisone
干预措施: Placebo and prednisone (Drug)
结局指标
主要结局
Time to prostate specific antigen (PSA) progression (TTPP)
时间窗: 14 months
Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria
次要结局
- Overall survival(5 years)
- Prostate specific antigen (PSA) response rate(14 months)
- Objective response rate(14 months)
- Quality of life (QoL) total score and each subscale score(14 months)
- Time to initiation of cytotoxic chemotherapy(5 years)
- Time to pain progression(14 months)
- Time to Eastern Cooperative Oncology Group (ECOG) performance status score determination(14 months)
- Collection of safety data including adverse events(5 years)