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

• Status: Unknown status
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Aker
• Treatments: Genistein

Criteria

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.