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Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Hohenheim.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University Hospital Tuebingen
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

February 20, 2012
May 13, 2012
March 2012
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01538316 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Prostate Cancer Prevention Trial With Quercetin and Genistein
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Primary Prevention of Prostate Cancer
  • 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
  • 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
  • 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
  • Active Comparator: Quercetin supplement
    Intervention: Dietary Supplement: Quercetin supplement
  • Active Comparator: Genistein supplement
    Intervention: Dietary Supplement: Genistein supplement
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2014
March 2014   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact: Antje Damms Machado, dipl. troph. antje.machado@uni-hohenheim.de
Germany
 
NCT01538316
ZEM 21 AII
No
Stephan C. Bischoff, MD, Professor, University of Hohenheim
University of Hohenheim
  • University Hospital Tuebingen
  • Provision of study products: Quercegen Pharmaceuticals LLC
Study Director: Stephan C Bischoff, MD, Prof. University of Hohenheim
Study Director: Arnulf Stenzl, MD, Prof. Dept. of Urology, University Hospital Tübingen, Germany
University of Hohenheim
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP