Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- PSA-progression-free survival (PSA-PFS)
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of enzalutamide in patients with non-metastatic castration resistant prostate cancer. The total duration of the study will be 5 years. All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment. The end of the study is defined as follow-up assessment date at 3 years after the last participant enrollment. Patients will primarily be assessed by prostate-specific antigen (PSA) progression-free survival (PFS).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed prostate cancer
- •Patients with history of radical prostatectomy or radiation therapy for radical treatment
- •Patients who receive continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist, or using surgical castration
- •Patients with serum testosterone 1.73 nmol/L (0.50 ng/dL) or less
- •Patients with history of bicalutamide or flutamide at any time after first recurrence confirmed since radical treatment completed
- •Patients with 3 increased PSA test results which measured consecutively at least one week apart during androgen deprivation therapy
- •Patients with serum PSA 1 micrograms/L (1 ng/mL) or more
- •Patients with no confirmed remote metastasis after diagnosis of prostate cancer (excluding lymph nodes metastasis with a minor axis of less than 15 mm which considered to be nonmeasurable in the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1)
- •Patients with asymptomatic prostate cancer
- •Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Patients with life expectancy of at least 12 months
- •Patients who have signed written informed consent to participate in this study
排除标准
- •Patients with history of any chemotherapy (including estramustine phosphate sodium hydrate (JAN)) or treatment with enzalutamide or abiraterone acetate
- •Patients with history of steroid usage as treatment for prostate cancer
- •Patients with history of 5-alpha-reductase inhibitor, estrogen or steroidal antiandrogen within past 4 weeks prior to initial administration of enzalutamide
- •Patients with history of malignant tumor other than prostate cancer within past 3 years
- •Patients with history of seizure or predisposing disease of seizure
- •Patients with severe liver dysfunction
- •Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
- •Patients who considered to be inappropriate for the study participation by the investigator.
研究组 & 干预措施
Enzalutamide Group
干预措施: Enzalutamide (Drug)
结局指标
主要结局
PSA-progression-free survival (PSA-PFS)
时间窗: 6 years
Prostate specific antigen (PSA) progression-free survival is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of \>= 25% and \>= 2 ng/ml above the nadir after initial dose) or date of death from any cause, whichever comes first.
次要结局
- Medication adherence (duration)(6 years)
- Overall survival (OS)(6 years)
- Metastasis free survival (MFS)(6 years)
- Time-to-PSA-progression (TTPP)(6 years)
- Progression-free survival (PFS)(6 years)
- Time to first use of chemotherapy (TFC)(6 years)
- QOL assessment using Japanese version of the FACT-P scales(Baseline, week 2, week 60, at withdrawal of treatment and at end of treatment for up to 6 years)
- PSA response rate(At week 2, and every 12 weeks for up to 6 years after initial dose)
- Medication adherence (dosage)(6 years)
- Medication adherence (ratio)(6 years)
- Safety assessment on the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0(6 years)