Role of Soy Supplementation in Prostate Cancer Development

NCT ID: NCT00255125

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-10-31

Brief 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.

Detailed 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.

Conditions

Prostate Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Arm Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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 Soy Supplement

Soy Supplement

Group Type: EXPERIMENTAL

Soy Supplement

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

Fla-vien; No other name

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Vanveldhuizen, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Kansas City MO

Locations

VA Medical Center, Kansas City MO

Kansas City, Missouri, United States

Countries

United States

References

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 trial. PLoS One. 2013 Jul 12;8(7):e68331. doi: 10.1371/journal.pone.0068331. Print 2013.

Reference Type: RESULT

PMID: 23874588 (View on PubMed)

Other Identifiers

CLIN-006-05S

Identifier Type: -

Identifier Source: org_study_id

NCT00285480

Identifier Type: -

Identifier Source: nct_alias