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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546039
Recruitment Status : Unknown
Verified September 2008 by University Hospital, Aker.
Recruitment status was:  Active, not recruiting
First Posted : October 18, 2007
Last Update Posted : September 30, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Genistein Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer
Study Start Date : April 2007
Actual Primary Completion Date : August 2008
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Genistein
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Genistein
Capsule, 30 mg, oral daily for 3 to 6 weeks
Other Name: BONISTEIN™
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00546039

Aker University Hospital
Oslo, Norway, 0514
Sponsors and Collaborators
University Hospital, Aker
Study Director: Steinar J Karlsen, MD, PhD Aker University Hospital, Oslo Urological Universityclinic
Principal Investigator: Bato Lazarevic, MD Aker University Hospital, Oslo Urological Universityclinic

Additional Information:
Responsible Party: Bato Lazarevic MD, Aker University Hospital Identifier: NCT00546039     History of Changes
Other Study ID Numbers: P2BV10
First Posted: October 18, 2007    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008

Keywords provided by University Hospital, Aker:
Prostate cancer
Localized prostatectomy
Laparoscopic prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists