Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer - Full Text View

Sponsored by:	University Hospital, Aker
Information provided by:	University Hospital, Aker
ClinicalTrials.gov Identifier:	NCT00546039

Purpose

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	Intervention	Phase
Prostatic Neoplasms	Drug: Genistein Drug: Placebo	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Genistein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	Effects of Synthetic Genistein Supplementation on Blood and Tissue Biomarkers in Patients With Localized Prostate Cancer

Further study details as provided by University Hospital, Aker:

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. [ Time Frame: 3 to 6 weeks ] [ Designated as safety issue: No ]

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™. [ Time Frame: 3 to 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	47
Study Start Date:	April 2007
Estimated Study Completion Date:	January 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Genistein Capsule, 30 mg, oral daily for 3 to 6 weeks
2: Placebo Comparator	Drug: Placebo Capsule

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546039

Locations

Norway
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

More Information

Additional Information:

Homepage Aker University Hospital This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Aker University Hospital ( Bato Lazarevic MD )
Study ID Numbers:	P2BV10
Study First Received:	October 17, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00546039 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Norway: The National Committees for Research Ethics in Norway; Norway: Data Inspectorate

Keywords provided by University Hospital, Aker:

Prostate cancer
Localized prostatectomy
Laparoscopic prostatectomy

Chemoprevention
Genistein
BONISTEIN™

Study placed in the following topic categories:

Anticarcinogenic Agents
Estrogens
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms

Genital Diseases, Male
Hormones
Protein Kinase Inhibitors
Phytoestrogens
Prostatic Neoplasms
Genistein

Additional relevant MeSH terms:

Anticarcinogenic Agents
Estrogens
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male

Protein Kinase Inhibitors
Protective Agents
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Estrogens, Non-Steroidal
Therapeutic Uses
Phytoestrogens
Prostatic Neoplasms
Genistein

ClinicalTrials.gov processed this record on May 07, 2009