This trial is active, not recruiting.

Condition prostatic neoplasms
Treatments genistein, placebo
Phase phase 2
Sponsor University Hospital, Aker
Start date April 2007
End date August 2008
Trial size 47 participants
Trial identifier NCT00546039, P2BV10


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
(Active Comparator)
genistein BONISTEIN™
Capsule, 30 mg, oral daily for 3 to 6 weeks
(Placebo Comparator)

Primary Outcomes

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.
time frame: 3 to 6 weeks

Secondary Outcomes

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™.
time frame: 3 to 6 weeks

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Official title Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer
Principal investigator Bato Lazarevic, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2008.
Information provided to ClinicalTrials.gov by University Hospital, Aker.