Randomized Phase II Study of Two Different Doses of RAD-001 (Everolimus) as Neo-Adjuvant Therapy in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Proportion of Patients Who Are P0 (i.e., no Clinically Detectable Tumor in the Pathologic Specimen) at Surgery
研究概览
简要总结
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus works in treating patients with newly diagnosed localized prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine the clinical effects of everolimus, in terms of pathologic response (i.e., histologic P0, margin status, or capsular penetration) and surgical outcome, in patients with newly diagnosed localized prostate cancer treated with two different doses of everolimus prior to radical prostatectomy.
- To evaluate the safety and tolerability of this drug in these patients.
Secondary
- To determine the effect of this drug on prostate-specific antigen (PSA) levels in these patients.
- To determine the effect of this drug on levels of expression of PTEN, Akt, phospho-mTOR (i.e., Se2448), phospho-p70 S6 kinase (i.e., Thre389), phospho-Smad3 (i.e., Ser433/435), phospho-Smads 1/5 (i.e., Ser463/465), AR, and TUNEL in these patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low-dose Everolimus Cohort
5mg Everolimus daily continuously for 8 weeks and conventional surgery
干预措施: Everolimus (Drug)
Low-dose Everolimus Cohort
5mg Everolimus daily continuously for 8 weeks and conventional surgery
干预措施: conventional surgery (Procedure)
High-dose Everolimus Cohort
10mg Everolimus daily continuously for 8 weeks and conventional surgery
干预措施: Everolimus (Drug)
High-dose Everolimus Cohort
10mg Everolimus daily continuously for 8 weeks and conventional surgery
干预措施: conventional surgery (Procedure)
结局指标
主要结局
Proportion of Patients Who Are P0 (i.e., no Clinically Detectable Tumor in the Pathologic Specimen) at Surgery
时间窗: After 8 weeks of therapy at the time of prostatectomy
Specimens are fixed in formalin for 24 hours.Specimens are the cut at 3 mm intervals perpendicular to the rectal surface and the sections are examined grossly and microscopically on routine Hematoxylin and Eosin stain (H\&E) (pathologic complete response or P0) will be defined as responders.
Toxicity Profile of Each Dose (Number of Patients With Worst Grade Toxicity)
时间窗: at daily dose for 8 weeks
Toxicity will be assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 3.0 (CTCAEv3.0)
次要结局
- Change in PSA(Up to 16 weeks after start of study)
研究者
Jorge A. Garcia, MD
Principal Investigator
Case Comprehensive Cancer Center