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

Phase 2
18 Years
Open (Enrolling)
Prostatic Neoplasms

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Trial Information

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

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.

Outcome Time Frame:

3 to 6 weeks

Safety Issue:


Principal Investigator

Steinar J Karlsen, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Aker University Hospital, Oslo Urological Universityclinic


Norway: Norwegian Medicines Agency

Study ID:




Start Date:

April 2007

Completion Date:

January 2009

Related Keywords:

  • Prostatic Neoplasms
  • Prostate cancer
  • Localized prostatectomy
  • Laparoscopic prostatectomy
  • Chemoprevention
  • Genistein
  • Neoplasms
  • Prostatic Neoplasms