Clinical trial NCT00255125: Role of Soy Supplementation in Prostate Cancer Development
Official title: Role of Soy Isoflavones in Prostate Cancer Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Neoplasm
Keywords: Estrogen Receptor
Isoflavones
Prostate Neoplasm
Soy Supplementation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-11-17
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Effect of Soy Isoflavones on Serum Testosterone Levels.
timeFrame: Two weeks
Secondary outcomes:
measure: Effect of Soy Isoflavones on Estrogen Receptor Status
timeFrame: Two weeks
measure: Molecular Effects of Soy Supplementation Compared to Placebo.
timeFrame: One year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: VA Medical Center, Kansas City MO
state: Missouri
Study officials:
affiliation: VA Medical Center, Kansas City MO
name: Peter Vanveldhuizen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.