Prostate Cancer Prevention Trial With Quercetin and Genistein

Primary Prevention of Prostate Cancer Clinical Trial

— QUERGEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01538316
• Other study ID #: ZEM 21 AII
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2012
• Last updated: May 13, 2012
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2012
• Source: University of Hohenheim
• Contact: Antje Damms Machado, dipl. troph.
• Email: antje.machado[@]uni-hohenheim.de
• Is FDA regulated: No
• Health authority: Germany: Ministry of Science, Research and Arts
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Primary Prevention of Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.
• Placebo
vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement.

Locations

Country	Name	City	State
Germany	Institute of Nutritional Medicine, University of Hohenheim	Stuttgart
Germany	Department of Urology, University Hospital Tübingen	Tübingen

Sponsors (3)

Lead Sponsor	Collaborator
University of Hohenheim	Quercegen Pharmaceuticals, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Prostate cancer incidence		over the whole study period of 18 months	Yes
Secondary	Quercetin- and genistein blood concentrations		Every three months (over a period of 18 months)	No
Secondary	IPSS (International Prostate Symptom Score)		Every three months (over a period of 18 months)	No
Secondary	Quality of Life	SF 36	Every three months (over a period of 18 months)	No