Prostate Cancer Prevention Trial With Quercetin and Genistein (QUERGEN)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2012 by University of Hohenheim.
Recruitment status was Recruiting

Sponsor:

Collaborators:

University Hospital Tuebingen

Provision of study products: Quercegen Pharmaceuticals LLC

Information provided by (Responsible Party):

Stephan C. Bischoff, MD, Professor, University of Hohenheim

ClinicalTrials.gov Identifier:

NCT01538316

First received: February 20, 2012

Last updated: May 13, 2012

Last verified: May 2012

History of Changes

Purpose

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	Intervention
Primary Prevention of Prostate Cancer	Dietary Supplement: Quercetin supplement Dietary Supplement: Genistein supplement Dietary Supplement: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer Prostate Cancer Screening

Drug Information available for: Genistein

U.S. FDA Resources

Further study details as provided by University of Hohenheim:

Primary Outcome Measures:

Increase in prostate-specific antigen [ Time Frame: Every three months (over a period of 18 months) ] [ Designated as safety issue: Yes ]
Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period

Secondary Outcome Measures:

Prostate cancer incidence [ Time Frame: over the whole study period of 18 months ] [ Designated as safety issue: Yes ]
Quercetin- and genistein blood concentrations [ Time Frame: Every three months (over a period of 18 months) ] [ Designated as safety issue: No ]
IPSS (International Prostate Symptom Score) [ Time Frame: Every three months (over a period of 18 months) ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: Every three months (over a period of 18 months) ] [ Designated as safety issue: No ]
SF 36


Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538316

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

Provision of study products: Quercegen Pharmaceuticals LLC

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

No publications provided


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
Study First Received:	February 20, 2012
Last Updated:	May 13, 2012
Health Authority:	Germany: Ministry of Science, Research and Arts

Keywords provided by University of Hohenheim:


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015

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