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

Sponsor

University Hospital, Aker (Other)

Overall Status

Unknown status

CT.gov ID

NCT00546039

Collaborator

(none)

Enrollment

Location

Arms

21.1

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Apr 1, 2007

Actual Primary Completion Date :

Aug 1, 2008

Anticipated Study Completion Date :

Jan 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

Drug: Genistein

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

Other Names:

BONISTEIN™

Placebo Comparator: 2

Drug: Placebo

Capsule

Outcome Measures

Primary Outcome Measures

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. [3 to 6 weeks]

Secondary Outcome Measures

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™. [3 to 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aker University Hospital	Oslo		Norway	0514

Sponsors and Collaborators

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