Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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
No
Steinar J Karlsen, MD, PhD
Study Director
Aker University Hospital, Oslo Urological Universityclinic
Norway: Norwegian Medicines Agency
P2BV10
NCT00546039
April 2007
January 2009
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