Prostate Cancer Prevention Trial With Quercetin and Genistein

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen

Conditions
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Primary Prevention of Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: Quercetin supplement
* Dietary Supplement: Genistein supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 smoker abnormal clinical laboratory values at baseline participation in any other trial with an investigational new drug inability to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quercetin supplement<br> | Dietary Supplement: Quercetin supplement<br>* 500 mg/d quercetin (+ vitamin C + folic acid + vitamin B3) over a period of six months; crossover design (6 month-periods): followed by genistein and placebo supplement.<br>* Other names: Q-Force Chew;|
| Active Comparator: Genistein supplement<br> | Dietary Supplement: Genistein supplement<br>* 100 mg/d genistein (+ vitamin C + folic acid + vitamin B3) over a period of six months; crossover design (6 month-periods): followed by placebo and quercetin supplement.<br>* Other names: Q-Force Chew;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement.<br>* Other names: Q-Force Chew;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in prostate-specific antigen | Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period | Every three months (over a period of 18 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | SF 36 | Every three months (over a period of 18 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, dietary supplements, quercetin, genistein, prostate-specific antigen, oxidative Status