Dynamics of Androgen Receptor Genomics and Transcriptomics After Neoadjuvant Androgen Ablation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Effects of enzalutamide on tumor downstaging
研究概览
简要总结
Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in early prostate cancer could lead to improved patient selection for treatment.
Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
Intervention : Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.
详细描述
Rationale: Understanding the mechanisms of enzalutamide as an androgen receptor inhibitor in early prostate cancer could lead to improved patient selection for treatment.
Objective: To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
Study design: A phase II prospective single-arm analysis. With a power of 80% to detect an expected reduction in positive surgical margin rate from 34% to 17% the investigators will have to included 55 men. For the AR/DNA interaction patients will serve as there own control since biopsies will be taken before and after enzalutamide treatment.
Study population: Patients over 18 years of age with localized prostate cancer that are planned for prostatectomy.
Intervention : Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men over 18 years of age.
- •clinically non-metastasized prostate cancer, tumor that can be imaged (TRUS or MRI) in order to allow for accurate preoperative biopsies.
- •Gleason score 7-10
- •written informed consent
- •WHO performance 0-1
排除标准
- •A history of seizures.
- •Clinically nodal metastases.
- •Prostatitis or urinary tract infection.
- •Androgen ablative therapy within 6 weeks of inclusion (including 5 alpha-reductase inhibitors).
- •Tumor of the prostate that can not be visualized by TRUS or MRI.
研究组 & 干预措施
Prostatectomy after enzalutamide
This is a single-arm study. Patients will have biopsies, after which they will receive enzalutamide for 3 months.
After 3 months they will have a prostatectomy.
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Effects of enzalutamide on tumor downstaging
时间窗: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
To study the effects of enzalutamide on surgical margin status and AR / DNA interaction and gene expression.
Genetic and transcriptional changes caused by enzalutamide
时间窗: From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).
The genetic and transcriptional changes caused by neoadjuvant androgen ablation by enzalutamide.
次要结局
- AR-dependant genes such as PSA, human kallikrein and PSMA(From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).)
- AR-chromatin binding alterations and Ki-67 expression(From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).)
- Clinical down-staging of enzalutamide pretreatment(From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).)
- Gleason grading(From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).)
- Find associated genes in prostate tissue, using tissue microarray (TMA).(From baseline (prior to treatment), until disease progression or as long as treatment is tolerated or until study completion (60 months).)