Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Herbal and Botanical

Estrogens

Soy Bean

Grapefruit Seed Extract

Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).

Soy Supplement

Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).

Placebo

Peter Vanveldhuizen, MD

This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patient will be randomized it either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. Patient's blood and prostate tissue will be evaluated to determine the effects of the soy supplement on the prostate tissue.

This is a randomized study evaluating the effectiveness and direct effect a commercial soy supplement has on prostate cancer and normal prostate tissue. Patients will be randomized to either receive placebo or a commercial soy supplement for 2-4 weeks prior to the planned surgery for treatment of their prostate cancer. The specific objectives are:

1. To assess the effect of soy supplementation on endogenous hormone production levels and serum prostate specific antigens.
2. To assess the impact of soy supplementation on estrogen receptor expression(ER).
3. To determine the impact of soy isoflavones on cell cycle regulation and associated gene expression.

Role of Soy Supplementation in Prostate Cancer Development

Role of Soy Isoflavones in Prostate Cancer Prevention

Total testosterone (ng/ml) serum levels were measured at the time of enrollment(baseline), after two weeks on soy supplement(time point 1), and just prior to prostatectomy (time point 2). All patients must have completed at least two week of soy supplement or placebo and time point 3 varied depending on date of planned prostatectomy. Results were analyzed and are reported at the two week time period, comparing between patients receiving soy supplement or placebo.

Samples of the prostate cancer tissue (paraffin embedded) were sectioned and placed on a glass slide. Using immunohistochemistry and an estrogen receptor antibody, sections were stained and assess to determine the extent of estrogen receptor expression. Patients in the soy supplement arm's samples results were compared to placebo arm results.

Using a tissue microarray targeting the cell cycle, selected fresh prostate cancer samples were evaluated in patients in the soy supplement arm compared to the placebo arm.

VA Office of Research and Development

Soy Supplement

Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).

Arm Soy Supplement

Placebo

Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice).

Arm Placebo

Total

Age, Continuous

Male

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Prostate cancer patient, randomized between to study groups; all patients with early stage prostate cancer.

Dr. Peter Van Veldhuizen

Effect of Soy Isoflavones on Serum Testosterone Levels.

Effect of Soy Isoflavones on Estrogen Receptor Status

Data and project staff no longer available to determine results.

Molecular Effects of Soy Supplementation Compared to Placebo.

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants will be asked to increase soy in their diet by an equivalent of 50mg/day for 12 months

Participants will consume 2 tablets of 50mg each per day for 12 months

Soy isoflavones delivered through diet, assisted by a detailed food guide for locally available soy-based foods.

Dietary soy

Soy isoflavones delivered in extracted form

Soo Hwang Teo

Globally, breast cancer is the most common cancer and the main cause of deaths due to cancer. This is attributed to changes in reproductive habits as well as an increasingly sedentary lifestyle, with low physical activity and diets rich in saturated fats but low in fiber. While the main focus in many Asian countries is to improve survival from breast cancer by encouraging early detection of the disease and improving access to cancer treatment, it does not reduce the number of women who will be diagnosed with breast cancer in the years to come. Currently, there is an urgent need to develop effective strategies to prevent breast cancer in Asia and beyond.

Soy may be an important dietary strategy for breast cancer prevention. Compared to women in the West, Asian women consume up to 10-fold more soy in their diet, which may, in part, explain their lower risk of breast cancer. Soybeans are rich in isoflavones, which can mimic estrogenic activity. In the body, it competes with estrogen and binds to estrogen receptor sites, thereby reducing the effect of estrogen and possibly lowering breast cancer risk.

Consistently, research has shown that Asian postmenopausal women who have high soy diets are less likely to be diagnosed with breast cancer. However, researchers have not been able to show that postmenopausal women can reduce their breast cancer risk by increasing soy intake as part of their diets. There are several reasons why these studies have failed to see an effect despite the body of evidence indicating that soy may be protective. Firstly, these are studies of Caucasian women who may have never been exposed to soy, particularly in adolescence, where soy may have the greatest impact. Also, these studies have used soy isoflavone supplements, rather than traditional soy foods made from whole soybeans, which may affect how soy is metabolized in the body. Lastly, the way in which mammographic density measurements were obtained previously could have negatively influenced the study results, such as the use of digitized images of mammogram films rather than raw digital images and the use of semi-automated methods that may be subject to human error and reader variability.

Therefore, a well-designed intervention study among Asian women living in Asia, using suitable mammographic density measures as a surrogate marker of breast cancer risk, will best answer these remaining gaps in our knowledge about the soy-breast cancer relationship.

The Malaysian Soy and Mammographic Density Study

The Malaysian Soy and Mammographic Density (MiSo) Study: A Randomized, Three-arm, Controlled Clinical Trial to Investigate the Impact of Soy Isoflavone Intake on Mammographic Density as a Biomarker of Breast Cancer Risk

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Role of Soy Supplementation in Prostate Cancer Development	NCT00255125	Prostate Neopla...	Soy Supplement Placebo	18 Years -	VA Office of Research and Development
Role of Soy Supplementation in Prostate Cancer Development	NCT00255125	Prostate Neopla...	Soy Supplement Placebo	18 Years -	VA Office of Research and Development
Role of Soy Supplementation in Prostate Cancer Development	NCT00255125	Prostate Neopla...	Soy Supplement Placebo	18 Years -	VA Office of Research and Development
The Malaysian Soy and Mammographic Density Study	NCT03686098	Breast Cancer Mammographic De...	Dietary soy Soy Supplement	45 Years - 65 Years	Cancer Research Malaysia

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