Prostate Cancer Prevention Trial With Quercetin and Genistein

Not Applicable

• Conditions: Primary Prevention of Prostate Cancer
• Interventions: Dietary Supplement: Quercetin supplement; Dietary Supplement: Genistein supplement; Dietary Supplement: Placebo

• Registration Number: NCT01538316
• Lead Sponsor: University of Hohenheim

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 Timeline

• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-02-20
• Study First Posted: 2012-02-24
• Study Start: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-13
• Last Update Posted: 2012-05-15
• Primary Completion: 2014-03
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Quercetin supplement	Quercetin supplement	-
Genistein supplement	Genistein supplement	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Increase in prostate-specific antigen	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

Secondary Outcome Measures

Name	Time	Method
Prostate cancer incidence	over the whole study period of 18 months
Quercetin- and genistein blood concentrations	Every three months (over a period of 18 months)
IPSS (International Prostate Symptom Score)	Every three months (over a period of 18 months)
Quality of Life	Every three months (over a period of 18 months)	SF 36

Trial Locations

Locations (2)

Department of Urology, University Hospital Tübingen; 🇩🇪 Tübingen, Germany

Institute of Nutritional Medicine, University of Hohenheim; 🇩🇪 Stuttgart, Germany