Randomized, Placebo-Controlled Six-Month Intervention Study of Soy Protein Isolate in Men with Biochemical Recurrence after Radical Prostatectomy: A Pilot Study.

There is evidence to suggest that soy may be beneficial for prostate cancer patients, but few randomized trials have addressed this. We examined the effect of 6-8 mo soy protein supplementation on prostate specific antigen (PSA) serum levels in men who recurred (PSA > 0.1 ng/ml) within three years of prostatectomy. Sixteen men were randomized to 20 g soy protein (∼24-26/day genistein; ∼40-43/day total isoflavones) or casein placebo. PSA was measured at base line and at 1, 2, 4, and 6-8 mo. Serum genistein levels greatly increased from baseline and cholesterol decreased in the soy group. In both treatment arms PSA increased similarly and PSA doubling times were not different over the 6-8 mo study duration. Two subjects in each group had stable PSA. A literature search for clinical studies of soy, isoflavones, and PSA revealed that supplementation with soy or isoflavones did not affect PSA in virtually all clinical studies identified. Although this study is too small to draw a definitive conclusion on the effect of soy protein on PSA in men with biochemical failure, the null finding in this study is consistent with the results of virtually all reports of soy and soy isoflavones in the literature.