The Specific Role of Isoflavones in Reducing Prostate Cancer Risk - Full Text View

Sponsors and Collaborators:	H. Lee Moffitt Cancer Center and Research Institute Cognis
Information provided by:	H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:	NCT00617617

Purpose

The purpose of this research study is to determine if giving men with early stage (Grade 1-2) prostate cancer dietary supplement from soybeans called isoflavones, will change their blood hormone levels. Isoflavones are substances found in a high concentration in soybeans that are converted in the intestines to hormone-like compounds which are similar to estrogen. They are also thought to have cancer fighting properties. Clinical trials suggest that isoflavones can increase certain sex hormones, which results in the slower production of prostate cancer cells. This study will determine if adding isoflavones (supplied as Prevastein HC®) 80 mg/day in a pill form can change your risk factors that cause early stage prostate cancer to progress to more advanced disease.

Condition	Intervention	Phase
Prostate Cancer	Dietary Supplement: Prevastein HC® Other: Placebo	Phase II

MedlinePlus related topics: Cancer Dietary Supplements Diets Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	The Specific Role of Isoflavones in Reducing Prostate Cancer Risk

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:

Observe the effects of the 12 - week intervention with isoflavones on sex hormones and PSA, a marker of disease progression. [ Time Frame: 12 week treatments ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	56
Study Start Date:	February 2002
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Dietary Supplement: Prevastein HC®	Dietary Supplement: Prevastein HC® Experimental Group - Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose) biologically active isoflavones.
B: Placebo Comparator Placebo	Other: Placebo Control Group - Control Group participants will receive an identical placebo.

Detailed Description:

To prevent biasing the outcome of the study, this is a double-blind study design, where both the trialists and the participants are blinded to the specific nature of the product (isoflavones and placebo). Participants in both groups will be discouraged from increasing their intake of dietary isoflavones in the form of tofu, soy beans, soy milk, etc. In addition, the intervention does not include active counseling on dietary modification and supplementation of any one group. Monthly appointments will be made for all participants for data collection and toxicity assessment.

Schema:

This is a controlled, randomized, double blinded clinical trial, having one experimental and one control group (n - 75/arm). Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose) biologically active isoflavones and those in the control group will receive an identical placebo. The isoflavones supplement and the placebo tablets will be manufactured and packaged by Cognis Corporation.

Isoflavones will be supplied at no charge by Cognis Corporation, LaGrange, Illinois as Prevastein HC®. Each Prevastein HC® tablet delivers 20 mg biologically active isoflavones, which is available for absorption. Participants will consume 2 tablets twice daily (with meals) in addition to their usual diet.
Placebo will be supplied at no charge by Cognis Corporation, LaGrange, Illinois as an indistinguishable tablet. Participants will consume 2 tablets twice daily (with meals) in addition to their usual diet.
A standardized multivitamin will be supplied at no charge.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males, between the ages of 50 and 80
Diagnosed with grade 1-2 prostate cancer (Gleason Score 2 to 6) Note: patients with a Gleason primary pattern 4 (4+1 or 4+2) are not eligible.
No prior or current therapy for prostate cancer
No other history of cancer except non-melanoma skin cancer
No known history of hepatic and/or renal disease
No evidence of prostatitis or urinary tract infection (men being treated with antibiotics may be enrolled 30 days after completion of therapy given that they still meet all other eligibility criteria)
No antibiotic use within 30 days of registration
Close to ideal body weight(Body Mass Index no greater than 32 Kg/m²)
Omnivorous diet
Able and willing to give written consent

Exclusion Criteria:

Less than 50 years or over 80 years of age
Prostate cancer beyond grade 2 (Gleason Score greater than 6)
Gleason primary pattern 4 (4+1 or 4+2)
Prior or planned treatment for prostate cancer of any stage
Prior history of other cancer except non-melanoma skin cancer
Current use of nutritional supplements, including modular supplements of other agents with antioxidant properties e.g. retinoids, beta-carotene, and isoflavones
Allergy to study agent
Known history of hepatic or renal disease
Body Mass Index greater than 32 Kg/m²
Vegetarian/vegan diet
Diet high in soy products (men who routinely consume a diet high in soy products may be enrolled 30 days after eliminating soy product from the diet)
Prostatitis or urinary tract infection
Treatment with antibiotics within 30 days of registration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617617

Locations

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Cognis

Investigators

Principal Investigator:

Nagi B. Kumar, PhD., RD

H. Lee Moffitt Cancer Center and Research Institute

More Information

Additional Information:

Moffitt Cancer Center Clinical Trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	H. Lee Moffitt Cancer Center and Research Institute ( Nagi B. Kumar, PhD., R.D., FADA )
Study ID Numbers:	MCC-12835, NCI #4031, CA 81920
Study First Received:	February 5, 2008
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00617617 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:

isoflavones
soy

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009