Apoptosis gene array of the prostate tumor specimen obtained from two patients with prostate cancer, one who consumed isoflavones and one who took the placebo.

<p>The figure shows the ratio of the gene to GAPDH.</p

Short-Term Soy Isoflavone Intervention in Patients with Localized Prostate Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial

<div><p>Purpose</p><p>We describe the effects of soy isoflavone consumption on prostate specific antigen (PSA), hormone levels, total cholesterol, and apoptosis in men with localized prostate cancer.</p><p>Methodology/Principal Findings</p><p>We conducted a double-blinded, randomized, placebo-controlled trial to examine the effect of soy isoflavone capsules (80 mg/d of total isoflavones, 51 mg/d aglucon units) on serum and tissue biomarkers in patients with localized prostate cancer. Eighty-six men were randomized to treatment with isoflavones (n = 42) or placebo (n = 44) for up to six weeks prior to scheduled prostatectomy. We performed microarray analysis using a targeted cell cycle regulation and apoptosis gene chip (GEArrayTM). Changes in serum total testosterone, free testosterone, total estrogen, estradiol, PSA, and total cholesterol were analyzed at baseline, mid-point, and at the time of radical prostatectomy. In this preliminary analysis, 12 genes involved in cell cycle control and 9 genes involved in apoptosis were down-regulated in the treatment tumor tissues versus the placebo control. Changes in serum total testosterone, free testosterone, total estrogen, estradiol, PSA, and total cholesterol in the isoflavone-treated group compared to men receiving placebo were not statistically significant.</p><p>Conclusions/Significance</p><p>These data suggest that short-term intake of soy isoflavones did not affect serum hormone levels, total cholesterol, or PSA.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href="http://clinicaltrials.gov/ct2/show/NCT00255125?term=NCT00255125&rank=1" target="_blank">NCT00255125</a></p></div

Baseline Characteristics of Participants.

<p>Baseline characteristics were compared using t-tests for continuous variables after checking normality assumptions and Fisher’s Exact test for categorical variables. P<0.05 was considered statistically significant. PSA = prostate-specific antigen; BMI = Body Mass Index.</p>1<p>Clinical stage based on the American Joint Committee on Cancer criteria.</p

Participant Flow Diagram.

<p>Participant Flow Diagram.</p

Prostate Specific Antigen, Serum hormones, and Total Cholesterol in men with prostate cancer who consumed isoflavones or placebo for up to 6 weeks.

<p>Data are means<u>+</u>SD. Analysis of covariance model was used to compare groups adjusted for the baseline value of the outcome. <i>P</i><0.05 was considered statistically significant.</p><p>Every patient had a maximum of 3 observations for each endpoint but the time of observation varied across patients due to the varied scheduling of the patients’ prostate cancer treatments.</p

Cell cycle gene array of the prostate tumor specimen obtained from two patients with prostate cancer, one who consumed isoflavones and one who took the placebo.

<p>The figure shows the ratio of the gene to GAPDH.</p

Demographic characteristics of 12 individuals with ADPKD who completed interviews after following a dietary intervention trial.

<p>Demographic characteristics of 12 individuals with ADPKD who completed interviews after following a dietary intervention trial.</p