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

18 Years
65 Years
Open (Enrolling)
Primary Prevention of Prostate Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Increase in prostate-specific antigen

Outcome Description:

Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period

Outcome Time Frame:

Every three months (over a period of 18 months)

Safety Issue:


Principal Investigator

Stephan C Bischoff, MD, Prof.

Investigator Role:

Study Director

Investigator Affiliation:

University of Hohenheim


Germany: Ministry of Science, Research and Arts

Study ID:




Start Date:

March 2012

Completion Date:

April 2014

Related Keywords:

  • Primary Prevention of Prostate Cancer
  • Prostate cancer
  • dietary supplements
  • quercetin
  • genistein
  • prostate-specific antigen
  • oxidative Status
  • Prostatic Neoplasms