NCT04268628已完成不适用
Exploratory Evaluation of Genetic Polymorphism and Pharmacodynamic Parameters in Samples of Abira-DES Study Subjects (NCT02217566) - Subjects With Metastatic Castration-Resistant Prostate Cancer Treated With Abiraterone Acetate Following Unresponsive Treatment With Diethylstilbestrol.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of Participants with and Without HSD3B1 (1245C) Germline Variant'
研究概览
简要总结
The primary purpose of this study is to evaluate the influence of HSD3B1 (1245C) germline variant and potential pharmacodynamic markers on abiraterone activity in participants with metastatic castration-resistant prostate cancer after unresponsive use of diethylstilbestrol.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Must have a confirmed diagnosis of prostate adenocarcinoma without neuroendocrine or small cell differentiation and was a participant in the Abira-DES study (NCT0221756), which includes: diethylstilbestrol pretreatment for castration-resistant prostate cancer with evidence of disease progression or grade 3/4 toxicity with diethylstilbestrol; metastatic disease confirmed by bone examination or metastatic lesions by computed tomography or magnetic resonance
- •Abiraterone acetate therapy during the Abira-DES study (NCT0221756), and peripheral blood samples have been collected from at least of the three proposed study timepoints
- •Must sign, and/or his/her legally acceptable representatives, where applicable, must sign the ICF allowing the use of clinical data and biological samples in accordance with local requirements. For deceased participants who did not provide consent prior to death, permission to research their information must meet local requirements
排除标准
- •Having withdrawn the consent to use the samples collected during their participation in the Abira-DES study (NCT02217566)
结局指标
主要结局
Percentage of Participants with and Without HSD3B1 (1245C) Germline Variant'
时间窗: Up to 12 months
Percentage of participants with and without HSD3B1 (1245C) germline variant will be determined to evaluate the influence of HSD3B1 (1245C) germline variant on the response to abiraterone as a predictive fact.
次要结局
- Levels of Metabolite Delta-(4)-Abiraterone (D4A) During the Abiraterone Acetate During Treatment Phase(12 Weeks)
- Correlation Between D4A Levels with Clinical Response(Up to 12 months)
- Correlation Between HSD3B1 (1245C) Variant and Testosterone Levels(Up to 12 months)
- Correlation Between D4A Levels with Testosterone Dosage(Up to 12 months)
- Testosterone Levels in Participants Treated with Abiraterone Acetate(Up to 12 months)
- Correlation Between HSD3B1 (1245C) Variant and Clinical Response(Up to 12 months)
- Correlation Between D4A Levels with SDHEA Dosage(Up to 12 months)
- Levels of HSD3B1 (1245C) Germ Variant(Up to 12 months)
- Correlation Between HSD3B1 (1245C) Variant and SDHEA Levels(Up to 12 months)
- SDHEA Levels in Participants Treated with Abiraterone Acetate(Up to 12 months)
研究者
研究点 (1)
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