Nutrition & Cancer, 2011, 63(6):889-98.

Efficacy and Safety of Short-Term Genistein Intervention in Patients with Localized Prostate Cancer Prior to Radical Prostatectomy: A Randomized, Placebo-Controlled, Double-Blind Phase 2 Clinical Trial

Bato Lazarevic, et al

Department of Urology, Oslo University Hospital, Oslo, Norway; et al

We conducted a placebo-controlled, block-randomized double-blind Phase 2 study to examine the effect of 30 mg synthetic genistein daily on serum and tissue biomarkers in patients with localized prostate cancer (CaP). Fifty-four study subjects were recruited and randomized to treatment with genistein (n = 23) or placebo (n = 24) for 3 to 6 wk prior to prostatectomy. Seven study subjects were noncompliant to the study protocol. Adverse events were few and mild. Serum prostate specific antigen (PSA) decreased by 7.8% in the genistein arm and increased by 4.4% in the placebo arm (P = 0.051). The PSA level was reduced in tumor tissue compared to normal tissue in the placebo arm. In the genistein arm, the PSA level in tumor and normal tissue was comparable. Total cholesterol was significantly lower in the genistein arm (P = 0.013). There were no significant effects on thyroid or sex hormones. Plasma concentrations of total genistein were on average 100-fold higher in the genistein arm after treatment (P < 0.001). Genistein at a dose that can be easily obtained from a diet rich in soy reduced the level of serum PSA in patients with localized CaP, without any effects on hormones. It was well tolerated and had a beneficial effect on blood cholesterol.

美国《营养和癌症》，2011年6月

金雀异黄素干短期预和前列腺癌根治术对于局部前列腺癌患者疗效及安全性的对比︰随机、 双盲安慰剂对照、 双盲第二阶段的临床试验

贝托 拉泽雷维奇等

挪威奥斯陆大学医院泌尿外科等

我们进行了一个双盲安慰剂对照、 区层随机双盲2 阶段的研究来测试每天30 mg合成染料木黄酮对局限性前列腺癌 (CaP) 患者血清和组织生物标志物的影响。招募54个受试者并在实施前列腺切除术3 到 6个星期之前将其随机分配到金雀异黄素组 (n = 23) 或安慰剂组 (n = 24)。7个研究受试者不顺从研究协议书。不良反应很少并轻微。血清前列腺特异性抗原 (PSA) 在金雀异黄素组下降了 7.8%而在安慰剂组增加了 4.4% (P = 为 0.051)。