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

September 29, 2008 updated by: University Hospital, Aker

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0514
        • Aker University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Capsule
Active Comparator: 1
Drug: Genistein
Capsule, 30 mg, oral daily for 3 to 6 weeks
Other Names:
  • BONISTEIN™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 to 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Aker

Investigators

  • Study Director: Steinar J Karlsen, MD, PhD, Aker University Hospital, Oslo Urological Universityclinic
  • Principal Investigator: Bato Lazarevic, MD, Aker University Hospital, Oslo Urological Universityclinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Anticipated)

January 1, 2009

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 17, 2007

First Posted (Estimate)

October 18, 2007

Study Record Updates

Last Update Posted (Estimate)

September 30, 2008

Last Update Submitted That Met QC Criteria

September 29, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2BV10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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