Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
研究概览
简要总结
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine whether genistein treatment will decrease the number of circulating prostate cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA extracted from peripheral blood mononuclear cells (PBMNCs).
SECONDARY OBJECTIVES:
I. Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy.
II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the nano-PSA assay.
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
- Double (Participant, Investigator)
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
- •Participants must have a pathologic diagnosis of prostate cancer within the past 6 months, have clinical stage T1-3 disease, PSA >= 10, Gleason score >= 8, and have elected to undergo radical prostatectomy; those found to have detectable circulating prostate cancer cells in the blood as detected by qRT-PCR for PSA will be eligible to proceed onto the treatment phase of the protocol; pathology slides used for diagnosis will be submitted to the SPORE tissue pathology core for review
- •ECOG performance status 0-1
- •Hemoglobin > 9.0gm/dl
- •Platelets >= 100 K/uL
- •ANC > 1000/uL
- •AST (SGOT)/ALT (SGPT) < 3X upper limit of normal
- •Creatinine < 2.0 mg/dl
- •Total bilirubin < 2 mg/dl (Note: Subjects with a higher level of bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
- •Participants must agree not to take soy supplements
- •Ability to understand and the willingness to sign a written informed consent document
- •Willingness to take study agent for at least 2 weeks prior to radical prostatectomy
- •History of venous thrombosis within past year
- •Participants must not be receiving active therapy for neoplastic disorders (including hormone or radiation therapy for prostate cancer)
- •Participants may not be receiving any other investigational agents
- •Known soy intolerance
- •Medical conditions that, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
干预措施: therapeutic conventional surgery (Procedure)
Arm I
Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
干预措施: genistein (Dietary Supplement)
Arm II
Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
干预措施: placebo (Other)
Arm II
Patients receive an oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy.
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs
时间窗: At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
Blood will be collected to analyze the number of CPC's at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.
次要结局
- Measure the Effect of Genistein on Select Gene and Protein Expressions in Prostate Tissue(At baseline and at time of surgery)
- Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy(At baseline, 1 and 12 months after surgery)
- Measurement of PSA in Serum and Plasma by Nanotechnology(At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery)