We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Specific Role of Isoflavones in Reducing Prostate Cancer Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617617
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : September 24, 2012
Sponsor:
Collaborator:
Cognis
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: Prevastein HC® Other: Placebo Phase 2

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.

  1. 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.
  2. 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.
  3. A standardized multivitamin will be supplied at no charge.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
Study Start Date : February 2002
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: A
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.
Placebo Comparator: B
Placebo
 Other: Placebo
Control Group - Control Group participants will receive an identical placebo.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617617


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Nagi B. Kumar, PhD., RD H. Lee Moffitt Cancer Center and Research Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00617617    
Obsolete Identifiers: NCT00027950
Other Study ID Numbers: MCC-12835
NCI #4031
CA 81920
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: February 2010
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
isoflavones
soy
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases