Clinical trial · Interventional
Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer
Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer
NCT00546039CI-TRIAL-00001705unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to evaluate safety and mechanisms of possible chemopreventive effects of synthetic genistein (BONISTEIN™) in patients with localized prostate cancer undergoing laparoscopic radical prostatectomy.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genistein | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Genistein
- type
- PLACEBO_COMPARATOR
- label
- 2
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Modulation of biomarkers: PSA, Testosterone, STAMP1, STAMP2, NKX3A and KLK4, p21, p27, p53, bcl-2, bax, Ki67, CgA and NSE in blood and/or prostate tissue.
- timeFrame
- 3 to 6 weeks
Secondary outcomes (1)
- measure
- Modulation of prostate cancer grade, volume and Gleason score. Safety parameters (blood, electrolytes, liver, pancreas, lipids, thyroid and sexual hormones). Plasma and tissue concentrations of BONISTEIN™.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven prostate cancer clinical stage T1c or T2. * Are to be treated by radical prostatectomy 3 to 6 weeks after consent. * Have signed the informed consent form. Exclusion Criteria: * Have been on previous or concurrent hormonal therapy or chemotherapy. * History of previous or other hormone dependent malignancies. * Concomitant thyroid disease or are currently taking thyroid hormone replacement medication. * On current high dose soy, micronutrient or herbal supplements. * On soy or vegetarian nutrition or have any other extreme dietary habits. * On oral anticoagulants. * History of liver or pancreas diseases. * History of hypersensitivity to Genistein or soy containing products. * Have a malabsorption condition which might interfere with absorption of the investigational product.
References
Publications (0)
Data not yet available
No reference posted for this study.