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Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)

This study is currently recruiting participants.
Verified May 2012 by University of Hohenheim
Sponsor:
Collaborators:
University Hospital Tübingen, Department of Urology, Tübingen
Provision of study products: Quercegen Pharmaceuticals LLC
Information provided by (Responsible Party):
Stephan C. Bischoff, MD, Professor, University of Hohenheim
ClinicalTrials.gov Identifier:
NCT01538316
First received: February 20, 2012
Last updated: May 13, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Primary Prevention of Prostate Cancer
 Dietary Supplement: Quercetin supplement
Dietary Supplement: Genistein supplement
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen

Resource links provided by NLM:

Drug Information available for: Genistein
U.S. FDA Resources

Further study details as provided by University of Hohenheim:

Primary Outcome Measures:
  • Increase in prostate-specific antigen [ Time Frame: Every three months (over a period of 18 months) ] [ Designated as safety issue: Yes ]
    Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period


Secondary Outcome Measures:
  • Prostate cancer incidence [ Time Frame: over the whole study period of 18 months ] [ Designated as safety issue: Yes ]
  • Quercetin- and genistein blood concentrations [ Time Frame: Every three months (over a period of 18 months) ] [ Designated as safety issue: No ]
  • IPSS (International Prostate Symptom Score) [ Time Frame: Every three months (over a period of 18 months) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Every three months (over a period of 18 months) ] [ Designated as safety issue: No ]
    SF 36


Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538316

Contacts
Contact: Antje Damms Machado, dipl. troph. antje.machado@uni-hohenheim.de

Locations
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.            
Sponsors and Collaborators
University of Hohenheim
University Hospital Tübingen, Department of Urology, Tübingen
Provision of study products: Quercegen Pharmaceuticals LLC
Investigators
Study Director: Stephan C Bischoff, MD, Prof. University of Hohenheim
Study Director: Arnulf Stenzl, MD, Prof. Dept. of Urology, University Hospital Tübingen, Germany
  More Information

No publications provided

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
Study First Received: February 20, 2012
Last Updated: May 13, 2012
Health Authority: Germany: Ministry of Science, Research and Arts

Keywords provided by 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
Prostatic Diseases
Genital Diseases, Male
Quercetin
Genistein
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Protective Agents
Physiological Effects of Drugs
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013