search
Back to results

Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)

Primary Purpose

Primary Prevention of Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Quercetin supplement
Genistein supplement
Placebo
Sponsored by
University of Hohenheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Primary Prevention of Prostate Cancer focused on measuring Prostate cancer, dietary supplements, quercetin, genistein, prostate-specific antigen, oxidative Status

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Nutritional Medicine, University of HohenheimRecruiting
  • Department of Urology, University Hospital TübingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Quercetin supplement

Genistein supplement

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Increase in prostate-specific antigen
Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period

Secondary Outcome Measures

Prostate cancer incidence
Quercetin- and genistein blood concentrations
IPSS (International Prostate Symptom Score)
Quality of Life
SF 36

Full Information

First Posted
February 20, 2012
Last Updated
May 13, 2012
Sponsor
University of Hohenheim
Collaborators
University Hospital Tuebingen, Quercegen Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01538316
Brief Title
Prostate Cancer Prevention Trial With Quercetin and Genistein
Acronym
QUERGEN
Official Title
Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hohenheim
Collaborators
University Hospital Tuebingen, Quercegen Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Prevention of Prostate Cancer
Keywords
Prostate cancer, dietary supplements, quercetin, genistein, prostate-specific antigen, oxidative Status

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quercetin supplement
Arm Type
Active Comparator
Arm Title
Genistein supplement
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin supplement
Other Intervention Name(s)
Q-Force Chew
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Genistein supplement
Other Intervention Name(s)
Q-Force Chew
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Q-Force Chew
Intervention Description
vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement.
Primary Outcome Measure Information:
Title
Increase in prostate-specific antigen
Description
Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period
Time Frame
Every three months (over a period of 18 months)
Secondary Outcome Measure Information:
Title
Prostate cancer incidence
Time Frame
over the whole study period of 18 months
Title
Quercetin- and genistein blood concentrations
Time Frame
Every three months (over a period of 18 months)
Title
IPSS (International Prostate Symptom Score)
Time Frame
Every three months (over a period of 18 months)
Title
Quality of Life
Description
SF 36
Time Frame
Every three months (over a period of 18 months)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with deviant PSA constellation: Patients with PSA 2,5 - 4 μg/l and free PSA/total PSA < 15 % 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antje Damms Machado, dipl. troph.
Email
antje.machado@uni-hohenheim.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan C Bischoff, MD, Prof.
Organizational Affiliation
University of Hohenheim
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arnulf Stenzl, MD, Prof.
Organizational Affiliation
Dept. of Urology, University Hospital Tübingen, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Nutritional Medicine, University of Hohenheim
City
Stuttgart
ZIP/Postal Code
70599
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antje Damms Machado, dipl. troph.
Email
antje.machado@uni-hohenheim.de
First Name & Middle Initial & Last Name & Degree
Stephan C Bischoff, MD, Prof.
Facility Name
Department of Urology, University Hospital Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Aufderklamm, MD
First Name & Middle Initial & Last Name & Degree
Arnulf Stenzl, MD, Prof.

12. IPD Sharing Statement

Learn more about this trial

Prostate Cancer Prevention Trial With Quercetin and Genistein

We'll reach out to this number within 24 hrs