Role of Soy Supplementation in Prostate Cancer Development

Prostate Neoplasm Clinical Trial

Official title:

Role of Soy Isoflavones in Prostate Cancer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255125
• Other study ID #: CLIN-006-05S
• Status: Completed
• Phase: Phase 3
• Start date: September 2005
• Est. completion date: October 2009

Study information

• Verified date: June 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Other known NCT identifiers

• NCT00285480

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically proven prostate cancer.

• Surgical candidate for prostatectomy.

• During study period, must agree not to take new supplements.

• No concurrent chemotherapy, radiation or hormonal therapy.

• No history of prior allergy to soy based products.

• Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.

• Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy.

• Must give written and informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

During study period, must agree not to take new supplements.

• No concurrent chemotherapy, radiation or hormonal therapy.

• No history of prior allergy to soy based products.

• Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.

• Must be able to safely be on study supplements for period of at least two weeks prior to scheduled

Related Conditions & MeSH terms

• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Drug:
• 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).
• 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).

Locations

Country	Name	City	State
United States	VA Medical Center, Kansas City MO	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hamilton-Reeves JM, Banerjee S, Banerjee SK, Holzbeierlein JM, Thrasher JB, Kambhampati S, Keighley J, Van Veldhuizen P. Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Soy Isoflavones on Serum Testosterone Levels.	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.	Two weeks
Secondary	Effect of Soy Isoflavones on Estrogen Receptor Status	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.	Two weeks
Secondary	Molecular Effects of Soy Supplementation Compared to Placebo.	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.	One year