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

NCT00546039 | Unknown Phase 2 DMC

• 1 other identifier: P2BV10
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

Prostate cancer; Localized prostatectomy; Laparoscopic prostatectomy; Chemoprevention; Genistein; BONISTEIN™

Outcome Measures

Primary Outcomes (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.

  3 to 6 weeks

Secondary Outcomes (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™.

  3 to 6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Genistein

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Genistein DRUG

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

Also known as: BONISTEIN™

1

Placebo DRUG

Capsule

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Aker: lead

Study Sites (1)

Aker University Hospital

Oslo, 0514, Norway

Location

Related Links

• Homepage Aker University Hospital

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Genistein

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Steinar J Karlsen, MD, PhD

  Aker University Hospital, Oslo Urological Universityclinic

  STUDY DIRECTOR

• Bato Lazarevic, MD

  Aker University Hospital, Oslo Urological Universityclinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 18, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2009
• Last Updated: September 30, 2008

Record last verified: 2008-09

Locations

NO (1)