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Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
University Hospital Tuebingen
Quercegen Pharmaceuticals
Information provided by (Responsible Party):
Stephan C. Bischoff, MD, Professor, University of Hohenheim

Tracking Information
First Submitted Date  ICMJE February 20, 2012
First Posted Date  ICMJE February 24, 2012
Last Update Posted Date May 15, 2012
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01538316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostate Cancer Prevention Trial With Quercetin and Genistein
Official Title  ICMJE Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Primary Prevention of Prostate Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 20, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01538316
Other Study ID Numbers  ICMJE ZEM 21 AII
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephan C. Bischoff, MD, Professor, University of Hohenheim
Study Sponsor  ICMJE University of Hohenheim
Collaborators  ICMJE
  • University Hospital Tuebingen
  • Quercegen Pharmaceuticals
Investigators  ICMJE
Study Director: Stephan C Bischoff, MD, Prof. University of Hohenheim
Study Director: Arnulf Stenzl, MD, Prof. Dept. of Urology, University Hospital Tübingen, Germany
PRS Account University of Hohenheim
Verification Date May 2012

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