Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Increase in prostate-specific antigen
研究概览
简要总结
The aim of the randomized controlled double-blind crossover trial is to evaluate the effectiveness of two dietary supplements containing polyphenolic phytochemicals (isoflavonoid genistein and flavonoid quercetin) in comparison with placebo on the rate of increase in prostate-specific antigen (PSA). In addition, secondary objective is to evaluate the incidence of prostate cancer and to analyze malondialdehyde and protein carbonyle as indicators of the oxidative status.
详细描述
Prostate cancer (PC) is the most frequently occurring cancer in men. Its clinical incidence and mortality rates vary geographically, being much lower in Asia than in Western countries. Notably, latent PCs seem to be equally distributed, thus supporting the hypothesis, that environmental factors may be important in prostate cancer progression. Moreover, epidemiological evidence strongly supports the concept that the incidence of clinical prostate cancer depends on lifestyle factors, mainly related to diet. The isoflavone genistein and the flavonoid quercetin have been identified as likely preventive candidates. The aim of the intended clinical trial is to evaluate the hypothesized effectiveness of polyphenolic phytochemicals with highly purified dietary supplements in patients at high risk of clinical PC and without systemic treatment. This will provide data, which serve as an important pre-requesite for targeted dietary interventions using alternative medicine as preventive measures in men with latent PC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with deviant PSA constellation:
- •Patients with PSA 2,5 - 4 μg/l and free PSA/total PSA < 15 %
- •Patients with PSA > 4 μg/l with negative punch biopsy of the prostate
排除标准
- •chronic liver diseases, impaired kidney function
- •inflammatory diseases of the urogenital tract
- •history of malignancy of any organ system, treated or untreated, within the past three years whether or not there is evidence of local recurrence or metastases
- •therapy with Doxazosin, Dutaserid and/ or Finasterid, Testosteron and other hormonal active medicaments
- •inflammatory bowel diseases
- •malabsorption/-digestion
- •hypersensitivity/allergy to soy
- •phytotherapy or intake of dietary supplements
- •abnormal clinical laboratory values at baseline
- •participation in any other trial with an investigational new drug
- •inability to sign informed consent
结局指标
主要结局
Increase in prostate-specific antigen
时间窗: Every three months (over a period of 18 months)
Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period
次要结局
- Prostate cancer incidence(over the whole study period of 18 months)
- Quercetin- and genistein blood concentrations(Every three months (over a period of 18 months))
- IPSS (International Prostate Symptom Score)(Every three months (over a period of 18 months))
- Quality of Life(Every three months (over a period of 18 months))
研究者
Stephan C. Bischoff, MD, Professor
MD, Professor of Medicine
University of Hohenheim