Prostate Cancer Prevention Trial With Quercetin and Genistein

NCT ID: NCT01538316

Last Updated: 2012-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Primary Prevention of Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Quercetin supplement

Group Type: ACTIVE_COMPARATOR

Quercetin supplement

Intervention Type: DIETARY_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

Group Type: ACTIVE_COMPARATOR

Genistein supplement

Intervention Type: DIETARY_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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_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.

Intervention Type: DIETARY_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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Q-Force Chew; Q-Force Chew; Q-Force Chew

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: collaborator

Quercegen Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Hohenheim

OTHER

Sponsor Role: lead

Responsible Party

Stephan C. Bischoff, MD, Professor

MD, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan C Bischoff, MD, Prof.

Role: STUDY_DIRECTOR

University of Hohenheim

Arnulf Stenzl, MD, Prof.

Role: STUDY_DIRECTOR

Dept. of Urology, University Hospital Tübingen, Germany

Locations

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, , Germany

Site Status: RECRUITING

Department of Urology, University Hospital Tübingen

Tübingen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Antje Damms Machado, dipl. troph.

Role: CONTACT

antje.machado@uni-hohenheim.de

Facility Contacts

Antje Damms Machado, dipl. troph.

Role: primary

antje.machado@uni-hohenheim.de

Stefan Aufderklamm, MD

Role: primary

Other Identifiers

ZEM 21 AII

Identifier Type: -

Identifier Source: org_study_id