Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Modulation of biomarkers: PSA, Testosterone, STAMP1, STAMP2, NKX3A and KLK4, p21, p27, p53, bcl-2, bax, Ki67, CgA and NSE in blood and/or prostate tissue.
研究概览
简要总结
The purpose of this study is to evaluate safety and mechanisms of possible chemopreventive effects of synthetic genistein (BONISTEIN™) in patients with localized prostate cancer undergoing laparoscopic radical prostatectomy.
详细描述
In Norway prostate cancer is the most frequently diagnosed cancer in the male and represents the second most common cause of cancer death among men. Epidemiological studies have shown an association between decreased prostate cancer risk and increased soy consumption. Genistein is the dominating plasma and tissue isoflavone in soybean products, and it has been attributed several anti-cancer effects. BONISTEIN™ is a novel product, consisting of >99,5 % synthetic Genistein aglycone. Chemoprevention is the ability of certain molecules to inhibit (partially or totally) induction or progression of the disease. Our study population consists of men diagnosed with localized prostate cancer who have agreed to undergo radical prostatectomy. This provides adequate amount of benign, premalignant and malignant tissue for studying the effects of potential chemopreventive agents on biomarkers of cell growth and differentiation in the prostatic tissues with immunohistochemistry. Prostatic tissue cells will also be selected with Lacer Capture Microdissection (LCM) before analysis with semi-quantitative RT-PCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histological proven prostate cancer clinical stage T1c or T
- •Are to be treated by radical prostatectomy 3 to 6 weeks after consent.
- •Have signed the informed consent form.
排除标准
- •Have been on previous or concurrent hormonal therapy or chemotherapy.
- •History of previous or other hormone dependent malignancies.
- •Concomitant thyroid disease or are currently taking thyroid hormone replacement medication.
- •On current high dose soy, micronutrient or herbal supplements.
- •On soy or vegetarian nutrition or have any other extreme dietary habits.
- •On oral anticoagulants.
- •History of liver or pancreas diseases.
- •History of hypersensitivity to Genistein or soy containing products.
- •Have a malabsorption condition which might interfere with absorption of the investigational product.
研究组 & 干预措施
1
干预措施: Genistein (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Modulation of biomarkers: PSA, Testosterone, STAMP1, STAMP2, NKX3A and KLK4, p21, p27, p53, bcl-2, bax, Ki67, CgA and NSE in blood and/or prostate tissue.
时间窗: 3 to 6 weeks
次要结局
- Modulation of prostate cancer grade, volume and Gleason score. Safety parameters (blood, electrolytes, liver, pancreas, lipids, thyroid and sexual hormones). Plasma and tissue concentrations of BONISTEIN™.(3 to 6 weeks)