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

Primary Purpose

Prostatic Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Genistein
Placebo
Sponsored by
University Hospital, Aker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prostatic Neoplasms focused on measuring Prostate cancer, Localized prostatectomy, Laparoscopic prostatectomy, Chemoprevention, Genistein, BONISTEIN™

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Aker University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

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.

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™.

Full Information

First Posted
October 17, 2007
Last Updated
September 29, 2008
Sponsor
University Hospital, Aker
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1. Study Identification

Unique Protocol Identification Number
NCT00546039
Brief Title
Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer
Official Title
Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Aker

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostate cancer, Localized prostatectomy, Laparoscopic prostatectomy, Chemoprevention, Genistein, BONISTEIN™

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Genistein
Other Intervention Name(s)
BONISTEIN™
Intervention Description
Capsule, 30 mg, oral daily for 3 to 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steinar J Karlsen, MD, PhD
Organizational Affiliation
Aker University Hospital, Oslo Urological Universityclinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bato Lazarevic, MD
Organizational Affiliation
Aker University Hospital, Oslo Urological Universityclinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aker University Hospital
City
Oslo
ZIP/Postal Code
0514
Country
Norway

12. IPD Sharing Statement

Links:
URL
http://www.aus.no/
Description
Homepage Aker University Hospital

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

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