The Specific Role of Isoflavones in Reducing Prostate Cancer Risk

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00617617

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

52

Starts

2002-02-01

Expected to finish

2007-05-01

Last updated by the study team

2012-09-24

Who can join

Age: 50 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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