Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Primary Prevention of Prostate Cancer	Dietary Supplement: Quercetin supplement; Dietary Supplement: Genistein supplement; Dietary Supplement: Placebo	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen
Study Start Date :	March 2012
Estimated Primary Completion Date :	March 2014
Estimated Study Completion Date :	April 2014

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Quercetin supplement	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.; Other Name: Q-Force Chew
Active Comparator: Genistein supplement	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.; Other Name: Q-Force Chew
Placebo Comparator: Placebo	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.; Other Name: Q-Force Chew

Outcome Measures

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Primary Outcome Measures :

1. Increase in prostate-specific antigen [ Time Frame: 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 :

1. Prostate cancer incidence [ Time Frame: over the whole study period of 18 months ]
2. Quercetin- and genistein blood concentrations [ Time Frame: Every three months (over a period of 18 months) ]
3. IPSS (International Prostate Symptom Score) [ Time Frame: Every three months (over a period of 18 months) ]
4. Quality of Life [ Time Frame: Every three months (over a period of 18 months) ]
   SF 36

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Antje Damms Machado, dipl. troph.		antje.machado@uni-hohenheim.de

Locations

Germany
Institute of Nutritional Medicine, University of Hohenheim	Recruiting
Stuttgart, Germany, 70599
Contact: Antje Damms Machado, dipl. troph. antje.machado@uni-hohenheim.de
Principal Investigator: Stephan C Bischoff, MD, Prof.
Department of Urology, University Hospital Tübingen	Recruiting
Tübingen, Germany, 72076
Contact: Stefan Aufderklamm, MD
Principal Investigator: Arnulf Stenzl, MD, Prof.

Sponsors and Collaborators

University of Hohenheim

University Hospital Tuebingen

Quercegen Pharmaceuticals

Investigators

Study Director:	Stephan C Bischoff, MD, Prof.	University of Hohenheim
Study Director:	Arnulf Stenzl, MD, Prof.	Dept. of Urology, University Hospital Tübingen, Germany

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Stephan C. Bischoff, MD, Professor, MD, Professor of Medicine, University of Hohenheim
ClinicalTrials.gov Identifier:	NCT01538316 History of Changes
Other Study ID Numbers:	ZEM 21 AII
First Posted:	February 24, 2012
Last Update Posted:	May 15, 2012
Last Verified:	May 2012

Keywords provided by Stephan C. Bischoff, MD, Professor, University of Hohenheim:

Prostate cancer; dietary supplements; quercetin	genistein; prostate-specific antigen; oxidative Status

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Genistein; Quercetin; Anticarcinogenic Agents; Protective Agents	Physiological Effects of Drugs; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Phytoestrogens; Estrogens, Non-Steroidal; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antioxidants