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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Increase in prostate-specific antigen
Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period
Every three months (over a period of 18 months)
Stephan C Bischoff, MD, Prof.
University of Hohenheim
Germany: Ministry of Science, Research and Arts
ZEM 21 AII