Department of Oncology, Division of Clinical Cancer Epidemiology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Box 423, 40530, Gothenburg, Sweden.
Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Trials. 2022 Dec 21;23(1):1041. doi: 10.1186/s13063-022-06995-2.
A high intake of phytoestrogens, found in soy, rye, and seeds, is associated with a reduced risk of a prostate cancer diagnosis. Previously, we found that the overall decreased risk of prostate cancer diagnosis in males with a high intake of phytoestrogens was strongly modified by a nucleotide sequence variant in the estrogen receptor-beta (ERβ) gene. However, we do not know if phytoestrogens can inhibit the growth of prostate cancer in males with established diseases. If there is an inhibition or a delay, there is reason to believe that different variants of the ERβ gene will modify the effect. Therefore, we designed an intervention study to investigate the effect of the addition of foods high in phytoestrogens and their interaction with the ERβ genotype on prostate tumor proliferation in patients with prostate cancer.
The PRODICA trial is a randomized ongoing intervention study in patients with low- and intermediate-risk prostate cancer with a Gleason score < 8, prostate-specific antigen (PSA) < 20, and scheduled for radical prostatectomy. The study is conducted at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention consists of a daily intake of soybeans and flaxseeds (~ 200 mg of phytoestrogens) until the surgery, approximately 6 weeks. The aim is to recruit 200 participants. The primary outcome is the difference in the proliferation marker Ki-67 between the intervention and the control groups. The genotype of ERβ will be investigated as an effect-modifying factor. Secondary outcomes include, e.g., concentrations of PSA and steroid hormones in the blood.
The results of the PRODICA trial will contribute important information on the relevance of increasing the intake of phytoestrogens in patients with prostate cancer who want to make dietary changes to improve the prognosis of their cancer. If genetic factors turn out to influence the effect of the intervention diet, dietary advice can be given to patients who most likely benefit from it. Dietary interventions are cost-effective, non-invasive, and result in few mild side effects. Lastly, the project will provide basic pathophysiological insights which could be relevant to the development of treatment strategies for patients with prostate cancer.
gov NCT02759380. Registered on 3 May 2016.
植物雌激素大量存在于大豆、黑麦和种子中，有研究显示其摄入量与前列腺癌诊断风险降低有关。此前，我们发现植物雌激素摄入量高的男性患前列腺癌的总体风险降低，这与雌激素受体-β（ERβ）基因的核苷酸序列变异有很强的相关性。然而，我们尚不清楚植物雌激素是否可以抑制已确诊前列腺疾病男性的肿瘤生长。如果有抑制或延迟作用，那么就有理由相信不同的 ERβ 基因变体将改变这种效果。因此，我们设计了一项干预研究，以调查添加富含植物雌激素的食物及其与 ERβ 基因型的相互作用对前列腺癌患者前列腺肿瘤增殖的影响。
PRODICA 试验是一项在瑞典哥德堡市萨尔格伦斯卡大学医院进行的、正在进行的、针对低危和中危前列腺癌患者的随机干预研究，这些患者的 Gleason 评分<8、前列腺特异性抗原（PSA）<20 且计划接受根治性前列腺切除术。该研究正在进行中，预计招募 200 名参与者。干预措施包括每天摄入大豆和亚麻籽（约 200 毫克植物雌激素），直到手术，大约 6 周。研究的主要终点是干预组和对照组之间增殖标志物 Ki-67 的差异。ERβ 基因型将作为一个效应修饰因子进行研究。次要结局包括血液中 PSA 和类固醇激素的浓度等。
PRODICA 试验的结果将提供有关增加前列腺癌患者植物雌激素摄入量的重要信息，这些患者希望通过饮食改变来改善癌症预后。如果遗传因素确实影响干预饮食的效果，那么可以向最有可能受益于这种饮食的患者提供饮食建议。饮食干预具有成本效益、非侵入性且副作用轻微。最后，该项目将提供基础病理生理学方面的见解，这可能与前列腺癌患者的治疗策略的发展有关。
gov NCT02759380。于 2016 年 5 月 3 日注册。
