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.

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

Spots Global Cancer Trial Database for soy supplementation