A Randomised, Double-Blind, Multicentre Phase Ⅲ Study to Evaluate Abiraterone Acetate Versus Placebo Combined With Prednisone in Subjects With Asymptomatic or Mild Symptoms Without Chemotherapy, Metastatic Castration Resistant Prostate Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 16
- 主要终点
- Time to PSA progression (TTPP）
研究概览
简要总结
Abiraterone acetate is an orally effective CYP17 inhibitor, which is metabolized into abiraterone in the body, and its inhibitory activity against CYP17 is 10-30 times that of ketoconazole. Clinical studies have shown that abiraterone acetate can significantly reduce the level of prostate specific antigen (PSA) in PCa patients, and help to reduce tumors, extending the lifespan of patients with advanced PCa for several years, and the toxicity is acceptable.
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
- •1.18 years and older, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, Life expectancy ≥ 6 months.
- •Prostate cancer.
- •Serum testosterone <50 ng/dL (or 1.7 nmol/L).
- •Prostate cancer progression or lesion metastasis.
- •Restriction of antiandrogen therapy.
- •Restriction of Radiation therapy.
- •The treatment period of ketoconazole for prostate cancer was not exceed 7 days.
- •Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.
- •Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.
- •Adequate laboratory indicators.
- •Must be able to swallow tablets.
- •No pregnant or breastfeeding women, and a negative pregnancy test.
- •Understood and signed an informed consent form.
排除标准
- •Prostate pathology results are neuroendocrine prostate cancer.
- •Has received cytotoxic chemotherapy or biological therapy for metastatic castration resistant prostate cancer.
- •Has contraindications to the use of prednisone.
- •A chronic disease that exceeds the prednisone dose in the study.
- •Uncontrolled high blood pressure.
- •Active or symptomatic viral hepatitis or other chronic liver disease.
- •Visceral metastasis or brain metastasis.
- •Pituitary or adrenal dysfunction.
- •Active autoimmune diseases require the use of hormone therapy.
- •Clinically significant heart disease.
- •Participated in other clinical trials within 4 weeks.
研究组 & 干预措施
Abiraterone acetate group
Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.
干预措施: Abiraterone Acetate (Drug)
Abiraterone acetate group
Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.
干预措施: Prednisone (Drug)
Placebo group
Subjects in this group administered 4 tablets abiraterone acetate blank analog tablet once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.
干预措施: Placebo (Drug)
Placebo group
Subjects in this group administered 4 tablets abiraterone acetate blank analog tablet once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.
干预措施: Prednisone (Drug)
结局指标
主要结局
Time to PSA progression (TTPP）
时间窗: Baseline up to 24 months
The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).
次要结局
- Eastern Cooperative Oncology Group (ECOG)(Baseline up to 24 months)
- Prostate specific antigen remission rate(Baseline up to 24 months)
- Prostate specific antigen remission time(Baseline up to 24 months)
- Overall Survival (OS)(Baseline up to 24 months)
- Objective Response Rate (ORR)(Baseline up to 24 months)
- To pain progression time(Baseline up to 24 months)
- Quality of life assessment scale (FACT-P)(Baseline up to 24 months)