A Phase II Randomized Trial of Lycopene-Rich Tomato Extract Among Men with High-Grade Prostatic Intraepithelial Neoplasia.
A Phase II Randomized Trial of Lycopene-Rich Tomato Extract Among Men with High-Grade Prostatic Intraepithelial Neoplasia.
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DOI：
10.1080/01635581.2015.1075560
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发表时间：
2015
期刊：
影响因子：
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通讯作者：
Ananthanarayanan V
中科院分区：
文献类型：
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作者：
Gann PH;Deaton RJ;Rueter EE;van Breemen RB;Nonn L;Macias V;Han M;Ananthanarayanan V
各种证据表明，番茄红素可能抑制前列腺癌的发展。我们在HGPIN患者中进行了一项为期6个月的重复活检随机试验。在这里，我们报告的结果，血清番茄红素，PSA和IGF蛋白，组织病理学审查，和组织标志物的增殖（MCM-2）和细胞周期抑制（p27）。参与者服用安慰剂或番茄提取物胶囊，其中含有30毫克/天的番茄红素。对治疗前和治疗后的活检进行免疫染色和数字评分。通过LC-MS-MS测定血清番茄红素。在二次分析中，病理学家盲法检查每个活检组织以评分组织学特征。58人完成了试验。治疗组血清番茄红素升高0.55 μmol/L，安慰剂组降低0.29 μmol/L。我们没有观察到组间PSA、IGF-1或IGFBP 3浓度的有意义的差异，也没有观察到上皮细胞核中MCM-2或p27表达的任何差异。治疗后癌症、HGPIN、萎缩或炎症的患病率相似;然而，更广泛的萎缩和更少的HGPIN在番茄红素组中更常见。尽管干预后血清番茄红素存在很大差异，但对血清或良性组织终点均无明显治疗效果。更大的研究是必要的，以确定是否可以复制HGPIN和局灶性萎缩的程度观察到的变化。
A diverse body of evidence suggests that lycopene might inhibit prostate cancer development. We conducted a 6-month repeat biopsy randomized trial among men with HGPIN. Here we report results for serum lycopene, PSA and IGF proteins, histopathological review, and tissue markers for proliferation (MCM-2) and cell cycle inhibition (p27). Participants consumed placebo or tomato extract capsules containing 30 mg/day lycopene. Pre- and post-treatment biopsies were immunostained and digitally scored. Serum lycopene was determined by LC-MS-MS. In secondary analyses, pathologists blindly reviewed each biopsy to score histological features. 58 men completed the trial. Serum lycopene increased 0.55 μmol/L with treatment and declined 0.29 μmol/L with placebo. We observed no meaningful differences in PSA, IGF-1 or IGFBP3 concentrations between groups, nor any differences in expression of MCM-2 or p27 in epithelial nuclei. Prevalences of cancer, HGPIN, atrophy or inflammation post-treatment were similar; however, more extensive atrophy and less extensive HGPIN was more common in the lycopene group. Despite large differences in serum lycopene following intervention, no treatment effects were apparent on either the serum or benign tissue endpoints. Larger studies are warranted to determine whether changes observed in extent of HGPIN and focal atrophy can be replicated.