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

NCT ID: NCT00546039

Last Updated: 2008-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostatic Neoplasms

Keywords

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Prostate cancer Localized prostatectomy Laparoscopic prostatectomy Chemoprevention Genistein BONISTEIN™

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Genistein

Intervention Type DRUG

Capsule, 30 mg, oral daily for 3 to 6 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule

Interventions

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Genistein

Capsule, 30 mg, oral daily for 3 to 6 weeks

Intervention Type DRUG

Placebo

Capsule

Intervention Type DRUG

Other Intervention Names

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BONISTEIN™

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Aker

OTHER

Sponsor Role lead

Responsible Party

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Aker University Hospital

Principal Investigators

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Steinar J Karlsen, MD, PhD

Role: STUDY_DIRECTOR

Aker University Hospital, Oslo Urological Universityclinic

Bato Lazarevic, MD

Role: PRINCIPAL_INVESTIGATOR

Aker University Hospital, Oslo Urological Universityclinic

Locations

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Aker University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Related Links

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http://www.aus.no/

Homepage Aker University Hospital

Other Identifiers

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P2BV10

Identifier Type: -

Identifier Source: org_study_id