High Risk Prostate Cancer Prevention Study

Over 180,000 new cases of prostate cancer are diagnosed in the United States each year,
making prostate cancer the most frequently diagnosed cancer in men. With an estimated
28,660 deaths occurring in 2008, prostate cancer is the second leading cause of cancer death
in men. In Kansas, prostate cancer is also the most frequent cancer among men and ranked
third (253 deaths in 2006) behind lung cancer (884 deaths in 2006) and colorectal cancer
(273 deaths in 2006) in cancer related mortality. Despite the significant morbidity and
mortality related to this disease, screening and treatment approaches remain controversial
and there is significant morbidity related to the treatment of early stage disease.
Preventative strategies and strategies which identify patients at highest risk are needed
desperately.

The goal of this proposal is to study the molecular effects of the chemopreventative agent,
finasteride in combination with dietary soy supplementation in patients at high risk for the
development prostate cancer.

Inclusion Criteria:

1. Based on the PSA, DRE and Family history of prostate cancer patients will be risk
stratified using Prostate Cancer Risk Calculator. Must have at least 25% chance of
prostate cancer development as assessed by the prostate cancer risk calculator.

2. During time of study period, patients must agree not to take any new vitamin
supplementation, soy or herbal supplement.

3. Must not be receiving concurrent chemotherapy, radiation or hormonal therapy.

4. No history of prior allergy and intolerability to soy-based products.

5. Must not have been taking any soy supplementation, soy isoflavones or finasteride
within 90 days prior to study enrollment.

6. Must be able to safely be on study supplements for period of at least four months.

7. All patients must have been informed of the investigational nature of this study and
must sign and give written informed consent in accordance with institutional and
federal guidelines.

8. All patients must be willing to undergo prestudy and follow-up assessment.

Exclusion Criteria:

1. Patients diagnosed with prostate cancer on initial biopsy

2. Patients with any active malignancy

3. Receiving any concurrent chemotherapy, hormonal therapy or radiation

4. Patient not compliant with treatment for at least 4 months

5. Patients with history of deep vein thrombosis, myocardial infarction, coronary artery
disease,and cerebrovascular accident in the last 6 months will also be excluded.

6. Patients on active anticoagulation will be excluded.

7. Patients with liver function tests more than 2 levels of upper limit of normal

8. Patients who develop more than grade 2 toxicity will also be removed from the study