Synthetic Genistein (BONISTEIN™) in Patients Who Are Undergoing Surgery for Prostate Cancer
Recruitment status was Active, not recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- 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 ]
- 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 |
|---|---|
| Active Comparator: 1 |
Drug: Genistein
Capsule, 30 mg, oral daily for 3 to 6 weeks
Other Name: BONISTEIN™
|
| Placebo Comparator: 2 |
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 |
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| Norway | |
| Aker University Hospital | |
| Oslo, Norway, 0514 | |
| 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:
No publications provided
| Responsible Party: | Bato Lazarevic MD, Aker University Hospital |
| ClinicalTrials.gov Identifier: | NCT00546039 History of Changes |
| Other Study ID Numbers: | P2BV10 |
| Study First Received: | October 17, 2007 |
| Last Updated: | September 29, 2008 |
| Health Authority: | Norway: Norwegian Medicines Agency Norway:National Committee for Medical and Health Research Ethics Norway: Data Protection Authority |
Keywords provided by University Hospital, Aker:
|
Prostate cancer Localized prostatectomy Laparoscopic prostatectomy |
Chemoprevention Genistein BONISTEIN™ |
Additional relevant MeSH terms:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Genistein Phytoestrogens Estrogens, Non-Steroidal Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anticarcinogenic Agents Protective Agents Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013