Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)
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ClinicalTrials.gov Identifier: NCT01538316 |
Recruitment Status
: Unknown
Verified May 2012 by Stephan C. Bischoff, MD, Professor, University of Hohenheim.
Recruitment status was: Recruiting
First Posted
: February 24, 2012
Last Update Posted
: May 15, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Prevention of Prostate Cancer | Dietary Supplement: Quercetin supplement Dietary Supplement: Genistein supplement Dietary Supplement: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen |
Study Start Date : | March 2012 |
Estimated Primary Completion Date : | March 2014 |
Estimated Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Quercetin supplement |
Dietary Supplement: Quercetin 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.
Other Name: Q-Force Chew
|
Active Comparator: Genistein supplement |
Dietary Supplement: Genistein 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.
Other Name: Q-Force Chew
|
Placebo Comparator: Placebo |
Dietary Supplement: Placebo
vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement.
Other Name: Q-Force Chew
|
- Increase in prostate-specific antigen [ Time Frame: 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
- Prostate cancer incidence [ Time Frame: over the whole study period of 18 months ]
- Quercetin- and genistein blood concentrations [ Time Frame: Every three months (over a period of 18 months) ]
- IPSS (International Prostate Symptom Score) [ Time Frame: Every three months (over a period of 18 months) ]
- Quality of Life [ Time Frame: Every three months (over a period of 18 months) ]SF 36

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538316
Contact: Antje Damms Machado, dipl. troph. | antje.machado@uni-hohenheim.de |
Germany | |
Institute of Nutritional Medicine, University of Hohenheim | Recruiting |
Stuttgart, Germany, 70599 | |
Contact: Antje Damms Machado, dipl. troph. antje.machado@uni-hohenheim.de | |
Principal Investigator: Stephan C Bischoff, MD, Prof. | |
Department of Urology, University Hospital Tübingen | Recruiting |
Tübingen, Germany, 72076 | |
Contact: Stefan Aufderklamm, MD | |
Principal Investigator: Arnulf Stenzl, MD, Prof. |
Study Director: | Stephan C Bischoff, MD, Prof. | University of Hohenheim | |
Study Director: | Arnulf Stenzl, MD, Prof. | Dept. of Urology, University Hospital Tübingen, Germany |
Responsible Party: | Stephan C. Bischoff, MD, Professor, MD, Professor of Medicine, University of Hohenheim |
ClinicalTrials.gov Identifier: | NCT01538316 History of Changes |
Other Study ID Numbers: |
ZEM 21 AII |
First Posted: | February 24, 2012 Key Record Dates |
Last Update Posted: | May 15, 2012 |
Last Verified: | May 2012 |
Keywords provided by Stephan C. Bischoff, MD, Professor, University of Hohenheim:
Prostate cancer dietary supplements quercetin |
genistein prostate-specific antigen oxidative Status |
Additional relevant MeSH terms:
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Genistein Quercetin Anticarcinogenic Agents Protective Agents |
Physiological Effects of Drugs Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Phytoestrogens Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antioxidants |