Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)

May 13, 2012 updated by: Stephan C. Bischoff, MD, Professor, University of Hohenheim

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Stuttgart, Germany, 70599
        • Recruiting
        • Institute of Nutritional Medicine, University of Hohenheim
        • Contact:
        • Principal Investigator:
          • Stephan C Bischoff, MD, Prof.
      • Tübingen, Germany, 72076
        • Recruiting
        • Department of Urology, University Hospital Tübingen
        • Contact:
          • Stefan Aufderklamm, MD
        • Principal Investigator:
          • Arnulf Stenzl, MD, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every three months (over a period of 18 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate cancer incidence
Time Frame: over the whole study period of 18 months
over the whole study period of 18 months
Quercetin- and genistein blood concentrations
Time Frame: Every three months (over a period of 18 months)
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)
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
Every three months (over a period of 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hohenheim

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

February 20, 2012

First Submitted That Met QC Criteria

February 20, 2012

First Posted (Estimate)

February 24, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 13, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEM 21 AII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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