NCT01538316

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2 years

First QC Date

February 20, 2012

Last Update Submit

May 13, 2012

Conditions

Primary Prevention of Prostate Cancer

Keywords

Prostate cancerdietary supplementsquercetingenisteinprostate-specific antigenoxidative Status

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • 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)

Study Arms (3)

Quercetin supplement

ACTIVE COMPARATOR
Dietary Supplement: Quercetin supplement

Genistein supplement

ACTIVE COMPARATOR
Dietary Supplement: Genistein supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Quercetin supplementDIETARY_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.

Also known as: Q-Force Chew
Quercetin supplement
Genistein supplementDIETARY_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.

Also known as: Q-Force Chew
Genistein supplement
PlaceboDIETARY_SUPPLEMENT

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

Also known as: Q-Force Chew
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with deviant PSA constellation:
  • Patients with PSA 2,5 - 4 μg/l and free PSA/total PSA \< 15 %
  • Patients with PSA \> 4 μg/l with negative punch biopsy of the prostate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, 70599, Germany

RECRUITING

Department of Urology, University Hospital Tübingen

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

genistein combined polysaccharide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Stephan C Bischoff, MD, Prof.

    University of Hohenheim

    STUDY DIRECTOR

  • Arnulf Stenzl, MD, Prof.

    Dept. of Urology, University Hospital Tübingen, Germany

    STUDY DIRECTOR

Central Study Contacts

Antje Damms Machado, dipl. troph.

CONTACT

antje.machado@uni-hohenheim.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor of Medicine

Study Record Dates

First Submitted

February 20, 2012

First Posted

February 24, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

DE(2)