Role of Soy Supplementation in Prostate Cancer Development

NCT00255125 | Completed Phase 3 Results DMC

• 1 other identifier: CLIN-006-05S
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Neoplasm

Keywords

Estrogen Receptor; Isoflavones; Prostate Neoplasm; Soy Supplementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Effect of Soy Isoflavones on Estrogen Receptor Status

  Two weeks

• Molecular Effects of Soy Supplementation Compared to Placebo.

  One year

Study Arms (2)

Arm Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Arm Soy Supplement

EXPERIMENTAL

Soy Supplement

Drug: Soy Supplement

Interventions

Soy Supplement 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).

Also known as: Fla-vien

Arm Soy Supplement

Placebo 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).

Also known as: No other name

Arm Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Medical Center, Kansas City MO

Kansas City, Missouri, 64128, United States

Location

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

  PMID: 23874588 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Peter Van Veldhuizen
• Organization: Kansas City VA Medical Center

peter.vanveldhuizen@va.gov

816-861-4700

Study Officials

• Peter Vanveldhuizen, MD

  VA Medical Center, Kansas City MO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: September 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 18, 2019
• Results First Posted: June 17, 2015

Record last verified: 2019-06

Locations

US (1)