Safety of Purified Isoflavones in Men With Clinically Localized Prostate Cancer

Abstract

Our purpose was to evaluate the safety of 80 mg of purified isoflavones administered to men with early stage prostate cancer. A total of 53 men with clinically localized prostate cancer, Gleason score of 6 or below, were supplemented with 80 mg purified isoflavones or placebo for 12 wk administered in 2 divided doses of 40 mg to provide a continuous dose of isoflavones. Compliance, changes in plasma isoflavones, and clinical toxicity were analyzed at baseline, 4, and 12 wk. A total of 50 subjects completed the 12-wk intervention. A continuous, divided-dose administration of 80 mg/day of purified isoflavones at amounts that exceeded normal American dietary intakes significantly increased (P < 0.001) plasma isoflavones in the isoflavone-treated group compared to placebo and produced no clinical toxicity. With the current evidence on the cancer preventive properties of isoflavones, these results are significant and offer promise for these phytochemicals to be developed as potent agents to prevent cancer progression.

Acknowledgments and Notes

The research study was funded by the National Institute of Health—National Cancer Institute U10 CA81920.

Notes

a: Two sample t-tests comparing treatment group with placebo group at baseline.

b: Two sample t-tests comparing treatment group with placebo group at Month 1 or Month 3.

a: P value indicates number of the episodes of adverse events comparing treatment arm to placebo arm.