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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
| Quercegen Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quercetin supplement | Active Comparator |
| |
| Genistein supplement | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quercetin supplement | Dietary Supplement | 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. |
| 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) |
| 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) | |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antje Damms Machado, dipl. troph. | Contact | antje.machado@uni-hohenheim.de |
| Name | Affiliation | Role |
|---|---|---|
| Stephan C Bischoff, MD, Prof. | University of Hohenheim | Study Director |
| Arnulf Stenzl, MD, Prof. | Dept. of Urology, University Hospital Tübingen, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutritional Medicine, University of Hohenheim | Recruiting | Stuttgart | 70599 | Germany |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C473311 | genistein combined polysaccharide |
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|
| Genistein supplement | Dietary Supplement | 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. |
|
|
| Placebo | Dietary Supplement | vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement. |
|
|
| 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) |
| Department of Urology, University Hospital Tübingen | Recruiting | Tübingen | 72076 | Germany |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |