QUERGEN: Prostate Cancer Prevention Trial With Quercetin and Genistein

• Sponsor: University of Hohenheim (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01538316
• Collaborator: University Hospital Tuebingen (Other), Quercegen Pharmaceuticals (Industry)
• Enrollment: 60
• Locations: 2
• Arms: 3
• Duration (Months): 25
• Patients Per Site: 30
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Prevention of Prostate Cancer	Dietary Supplement: Quercetin supplement; Dietary Supplement: Genistein supplement; Dietary Supplement: Placebo	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2012
• Anticipated Primary Completion Date: Mar 1, 2014
• Anticipated Study Completion Date: Apr 1, 2014

Arms and Interventions

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 Names: 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 Names: 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 Names: Q-Force Chew

Outcome Measures

Primary Outcome Measures

1. Increase in prostate-specific antigen [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

Secondary Outcome Measures

1. Prostate cancer incidence [over the whole study period of 18 months]

2. Quercetin- and genistein blood concentrations [Every three months (over a period of 18 months)]

3. IPSS (International Prostate Symptom Score) [Every three months (over a period of 18 months)]

4. Quality of Life [Every three months (over a period of 18 months)]

   SF 36

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with deviant PSA constellation:

1. Patients with PSA 2,5 - 4 μg/l and free PSA/total PSA < 15 %

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Nutritional Medicine, University of Hohenheim	Stuttgart		Germany	70599
2	Department of Urology, University Hospital Tübingen	Tübingen		Germany	72076

Sponsors and Collaborators

• University of Hohenheim
• University Hospital Tuebingen
• Quercegen Pharmaceuticals

Investigators

• Study Director: Stephan C Bischoff, MD, Prof., University of Hohenheim
• Study Director: Arnulf Stenzl, MD, Prof., Dept. of Urology, University Hospital Tübingen, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephan C. Bischoff, MD, Professor, MD, Professor of Medicine, University of Hohenheim
• ClinicalTrials.gov Identifier: NCT01538316
• Other Study ID Numbers: ZEM 21 AII
• First Posted: Feb 24, 2012
• Last Update Posted: May 15, 2012
• Last Verified: May 1, 2012

• Keywords provided by Stephan C. Bischoff, MD, Professor, MD, Professor of Medicine, University of Hohenheim: Prostate cancer; dietary supplements; quercetin; genistein; prostate-specific antigen; oxidative Status
• Additional relevant MeSH terms: Prostatic Neoplasms; Genistein; Quercetin

Study Results

No Results Posted as of May 15, 2012