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

Phase 2

• Conditions: Prostatic Neoplasms
• Interventions: Drug: Genistein; Drug: Placebo

• Registration Number: NCT00546039
• Lead Sponsor: University Hospital, Aker

Brief 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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-18
• Primary Completion: 2008-08
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-29
• Last Update Posted: 2008-09-30
• Study Completion: 2009-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 47

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Genistein	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Aker University Hospital; 🇳🇴 Oslo, Norway