Clinical trial · Interventional
Prostate Cancer Prevention Trial With Quercetin and Genistein
Clinical Trial on the Effectiveness of the Flavonoids Genistein and Quercetin in Men With Rising Prostate-specific Antigen
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Prevention of Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genistein supplement | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Quercetin supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Quercetin supplement
- interventionNames
- Dietary Supplement: Quercetin supplement
- type
- ACTIVE_COMPARATOR
- label
- Genistein supplement
- interventionNames
- Dietary Supplement: Genistein supplement
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 consentReferences
Publications (0)
Data not yet available