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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00546039
• Other study ID #: P2BV10
• Status: Unknown status
• Phase: Phase 2
• First received: October 17, 2007
• Last updated: September 29, 2008
• Start date: April 2007
• Est. completion date: January 2009

Study information

• Verified date: September 2008
• Source: University Hospital, Aker
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 47
• Est. completion date: January 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Genistein
Capsule, 30 mg, oral daily for 3 to 6 weeks
• Placebo
Capsule

Locations

Country	Name	City	State
Norway	Aker University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Aker

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Homepage Aker University Hospital