JPRN-jRCTs061180030已完成未知
Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide - JCASTRE-Zero
Sugimoto Mikio0 个研究点目标入组 66 人开始时间: 2019年2月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
Considering the study results comprehensively; the statistical analysis of time to event for primary and secondary endpoints, the statistical analysis that 50% of patients had PSA response until 2.8 months after the start of treatment, and QOL result, enzalutamide had a certain efficacy on non-metastatic castration-resistant prostate cancer. Considering other recent publication, there was no evident safety concern.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •1.Patients with histologically or cytologically confirmed prostate cancer
- •2.Patients with history of radical prostatectomy or radiation therapy for radical treatment
- •3.Patients who receive continuous androgen deprivation therapy using both gonadotropin-releasing hormone (GnRH) agonist and antagonist, or using surgical castration
- •4.Patients with serum testosterone 1.73 nmol/L (0.50 ng/dL) or less
- •5.Patients with history of bicalutamide or flutamide at any time after first recurrence confirmed since radical treatment completed
- •6.Patients with 3 increased PSA test results which measured consecutively at least one week apart during androgen deprivation therapy
- •7.Patients with serum PSA 1 micrograms/L (1 ng/mL) or more
- •8.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)
- •9.Patients with asymptomatic prostate cancer
- •10.Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •11.Patients with life expectancy of at least 12 months
- •12.Patients who have signed written informed consent to participate in this study
排除标准
- •1.Patients with history of any chemotherapy (including estramustine phosphate sodium hydrate (JAN)) or treatment with enzalutamide or abiraterone acetate
- •2.Patients with history of steroid usage as treatment for prostate cancer
- •3.Patients with history of 5-alpha-reductase inhibitor, estrogen or steroidal antiandrogen within past 4 weeks prior to initial administration of enzalutamide
- •4.Patients with history of malignant tumor other than prostate cancer within past 3 years
- •5.Patients with history of seizure or predisposing disease of seizure
- •6.Patients with severe liver dysfunction
- •7.Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study
- •8.Patients who considered to be inappropriate for the study participation by the investigator
研究者
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