Trials / Unknown
UnknownNCT00546039
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- University Hospital, Aker · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
In Norway prostate cancer is the most frequently diagnosed cancer in the male and represents the second most common cause of cancer death among men. Epidemiological studies have shown an association between decreased prostate cancer risk and increased soy consumption. Genistein is the dominating plasma and tissue isoflavone in soybean products, and it has been attributed several anti-cancer effects. BONISTEIN™ is a novel product, consisting of \>99,5 % synthetic Genistein aglycone. Chemoprevention is the ability of certain molecules to inhibit (partially or totally) induction or progression of the disease. Our study population consists of men diagnosed with localized prostate cancer who have agreed to undergo radical prostatectomy. This provides adequate amount of benign, premalignant and malignant tissue for studying the effects of potential chemopreventive agents on biomarkers of cell growth and differentiation in the prostatic tissues with immunohistochemistry. Prostatic tissue cells will also be selected with Lacer Capture Microdissection (LCM) before analysis with semi-quantitative RT-PCR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Genistein | Capsule, 30 mg, oral daily for 3 to 6 weeks |
| DRUG | Placebo | Capsule |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2008-08-01
- Completion
- 2009-01-01
- First posted
- 2007-10-18
- Last updated
- 2008-09-30
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT00546039. Inclusion in this directory is not an endorsement.