Primary Prevention of Prostate CancerQUERGENNCT01538316
Prostate Cancer Prevention Trial With Quercetin and Genistein
A study testing Quercetin supplement and Genistein supplement in people with Primary Prevention of Prostate Cancer, run by University of Hohenheim at 2 sites in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Primary Prevention of Prostate Cancer
- What is being tested?
- Quercetin supplement and Genistein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Antje Damms Machado, dipl. troph. contact
Germany2 sites, 2 recruiting
- Recruiting
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, 70599
Antje Damms Machado, dipl. troph., antje.machado@uni-hohenheim.de
Stephan C Bischoff, MD, Prof.
- Recruiting
Department of Urology, University Hospital Tübingen
Tübingen, 72076
Stefan Aufderklamm, MD
Arnulf Stenzl, MD, Prof.
About this study
Official title: Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen
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.
Read the 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
- Being tested
- Quercetin supplement, Genistein supplement, Placebo
- Keywords
- Prostate cancer, dietary supplements, quercetin, genistein, prostate-specific antigen, oxidative Status
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quercetin supplementDietary supplement
Also called Q-Force Chew
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 supplementDietary supplement
Also called Q-Force Chew
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.
PlaceboDietary supplement
Also called Q-Force Chew
vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement.
| Study group | Role | What they receive |
|---|---|---|
| Quercetin supplement | Active comparator | Not described Receives: Dietary Supplement: Quercetin supplement |
| Genistein supplement | Active comparator | Not described Receives: Dietary Supplement: Genistein supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in prostate-specific antigen
Effect on the slope of the regression line though all log2-transformed PSA measurements during the concerned period
Measured: Every three months (over a period of 18 months)
Secondary outcomes (4)
Prostate cancer incidence
Measured: over the whole study period of 18 months
Quercetin- and genistein blood concentrations
Measured: Every three months (over a period of 18 months)
IPSS (International Prostate Symptom Score)
Measured: Every three months (over a period of 18 months)
Quality of Life
SF 36
Measured: Every three months (over a period of 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Prevention of Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, Quercegen Pharmaceuticals
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
- Investigators
- Stephan C Bischoff, MD, Prof., Study director, University of HohenheimArnulf Stenzl, MD, Prof., Study director, Dept. of Urology, University Hospital Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538316
- Sponsor's protocol ID
- ZEM 21 AII
- Acronym
- QUERGEN
- Status last verified
- May 2012
- First submitted
- 20 Feb 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen
- ClinicalTrials.gov ID
- NCT01538316
- Acronym / sponsor ID
- QUERGEN / ZEM 21 AII
- Conditions
- Primary Prevention of Prostate Cancer
- Keywords
- Prostate cancer, dietary supplements, quercetin, genistein, prostate-specific antigen, oxidative Status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, Quercegen Pharmaceuticals
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quercetin supplement | Active comparator | Dietary Supplement: Quercetin supplement |
| Genistein supplement | Active comparator | Dietary Supplement: Genistein supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with deviant PSA constellation:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quercetin supplementAlso: Q-Force Chew500 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. | Dietary supplement | Quercetin supplement |
| Genistein supplementAlso: Q-Force Chew100 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. | Dietary supplement | Genistein supplement |
| PlaceboAlso: Q-Force Chewvitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement. | Dietary supplement | Placebo |
Primary outcome
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
4 secondary outcomes
Prostate cancer incidence
Time frame: over the whole study period of 18 months
Quercetin- and genistein blood concentrations
Time frame: Every three months (over a period of 18 months)
IPSS (International Prostate Symptom Score)
Time frame: Every three months (over a period of 18 months)
Quality of Life
Time frame: Every three months (over a period of 18 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antje Damms Machado, dipl. troph. contact
Stephan C Bischoff, MD, Prof. study director
University of Hohenheim
Arnulf Stenzl, MD, Prof. study director
Dept. of Urology, University Hospital Tübingen, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin supplement and Genistein supplement in people with Primary Prevention of Prostate Cancer, run by University of Hohenheim at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antje Damms Machado, dipl. troph. (antje.machado@uni-hohenheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in prostate-specific antigen (time frame: Every three months (over a period of 18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.