Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Genistein
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Genistein<br>* Capsule, 30 mg, oral daily for 3 to 6 weeks<br>* Other names: BONISTEIN™;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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™. |  | 3 to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Localized prostatectomy, Laparoscopic prostatectomy, Chemoprevention, Genistein, BONISTEIN™