Tomato-Soy Juice for Prostate Cancer

番茄大豆汁治疗前列腺癌

基本信息

批准号：
7433909
负责人：
STEVEN K CLINTON
金额：
$ 28万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-08-04 至 2010-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7433909
关键词：
Alternative Medicine Androgens Animal Model Antioxidants Apoptotic Biodistribution Biological Biological Markers Blood Carotenoids Catabolism Cells Chemicals Chemopreventive Agent Clinical Clinical Research Clinical Trials Coagulation Process Consumption Control Groups Count Cultured Cells Daily Data Development Diagnosis Diagnostic Neoplasm Staging Diet Dietary Intervention Dietary intake Dose Dose-Limiting Drug Industry Drug Kinetics Drug or chemical Tissue Distribution End Point Figs - dietary Food Food Processing Future Genistein Glycosides Goals Health Benefit Health Food Hormonal Hormones Human IGFBP3 gene In Vitro Incidence Insulin-Like Growth Factor Binding Protein 3 Insulin-Like Growth Factor I Intake Intervention Intervention Trial Investigation Isoflavones Juice Knowledge Label Laboratories Laboratory Study Liver Localized Malignant neoplasm of prostate Marketing Molecular Monitor Neurosecretory Systems Nuclear Grade Numbers Nutritional Ohio Outcome Oxidative Stress Oxygen PTEN gene Pathway interactions Pattern Phase Phase I Clinical Trials Phase III Clinical Trials Philosophy Phytochemical Prevention Prevention strategy Principal Investigator Process Property Prostate Prostate Cancer therapy Prostatectomy Proto-Oncogene Proteins c-akt Publishing Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Recording of previous events Records Recurrence Renal function Research Research Personnel Research Support Risk Rodent Rodent Model S-Phase Fraction Safety Scientist Severities Signal Transduction Soy Foods Soy germ Standards of Weights and Measures Support Groups Surrogate Endpoint Testing Testosterone Therapeutic Thinking Time Tissue Sample Tissues Tomatoes Toxic effect Tumor stage Urine Vascular Endothelial Growth Factors absorption angiogenesis base cancer prevention cancer therapy carcinogenesis cohort day design dosage evidence based guidelines functional food improved indexing lycopene men morphometry neoplastic cell novel patient safety polyphenol prevent programs prostate cancer prevention response sound soy soy protein isolate success tool tumor urinary

项目摘要

DESCRIPTION (provided by applicant): Rationale. Diets rich in tomato products and soy are hypothesized to reduce the risk of prostate cancer or perhaps, enhance the efficacy of prostate cancer therapy. Supporting data is derived from epidemiologic investigations, rodent models, and in vitro cell culture studies. Our research team has developed a processed food/nutriceutical combining lycopene-rich tomato juice with soy germ, with the goal of developing a standardized and easily consumed nutriceutical that can be employed in future large-scale, randomized, long-term intervention trials focusing upon prevention or treatment of prostate cancer. Hypothesis. We propose that a daily serving of a novel tomato-soy nutriceutical (OSU-TSJ-001) will cause a dose dependent increase in bioactive components (isoflavones, polyphenols, carotenoids) in the prostate, and alter biomarker patterns suggesting chemopreventive or therapeutic properties for prostate cancer. Experimental Approach. We will conduct a dose escalating phase I pre-prostatectomy clinical trial in 60 men that have clinically localized prostate cancer and have chosen prostatectomy for therapy. The dose escalating study will begin with 15 men consuming usual diets as the control group, with subsequent cohorts of 15 men consuming 5 oz per day, 10 oz per day, and 15 oz per day of the tomato-soy juice (OSU-TSJ-001). Men will consume the tomato-soy nutriceutical for a target of 28 days prior to undergoing prostatectomy. Aim 1. We hypothesize men will be compliant with consumption of the tomato-soy nutriceutical (OSU-TSJ- 001 ) with no dose limiting toxicity. History indicates that efforts to define toxicity and safety profiles are essential. Aim 2. We hypothesize that consumption of the tomato-soy nutriceutical (OSU-TSJ-001) will result in a dose dependent increase in the biodistribution of tomato-soy phytochemicals in blood and prostate tissue. Aim 3. We hypothesize that consumption of the tomato-soy nutriceutical (OSU-TSJ-001) alters blood hormonal patterns and biomarkers of oxidative stress that favor prostate cancer prevention. Aim 4. We will investigate histopathologic and molecular biomarkers associated with prostate carcinogenesis that may serve as surrogate endpoint biomarkers and provide information regarding their ability to be modulated by the tomato-soy nutriceutical (OSU-TSJ-001). Significance. The proposed study represents the first attempt to evaluate a novel "functional food" / neutriceutical containing tomato and soy components in a clinical trial targeting prostate cancer. Our objective is to develop the tomato-soy juice for future large scale randomized trials evaluating prostate cancer prevention or improved cancer therapy (prevent recurrence or improve outcomes of hormonal, biological, or chemical therapy). The phase I / II study provides essential safety and efficacy data along with valuable information regarding absorption and biodistribution of tomato-soy phytochemicals and the characterization of surrogate endpoint biomarkers relevant to mechanisms of action that may be useful in future randomized clinical trails.

描述（由申请人提供）：基本原理。据推测，富含番茄制品和大豆的饮食可以降低患前列腺癌的风险，或者可能增强前列腺癌治疗的功效。支持数据来自流行病学调查、啮齿动物模型和体外细胞培养研究。我们的研究团队开发了一种将富含番茄红素的番茄汁与大豆胚芽相结合的加工食品/营养品，目标是开发一种标准化且易于食用的营养品，可用于未来大规模、随机、长期干预试验，重点关注预防或治疗前列腺癌。假设。我们建议，每天服用一种新型番茄大豆营养品 (OSU-TSJ-001) 将导致前列腺中生物活性成分（异黄酮、多酚、类胡萝卜素）剂量依赖性增加，并改变生物标志物模式，表明其具有化学预防或治疗特性。前列腺癌。实验方法。我们将在 60 名患有临床局限性前列腺癌并选择前列腺切除术治疗的男性中进行剂量递增的 I 期前列腺切除术前临床试验。剂量递增研究将从 15 名正常饮食的男性作为对照组开始，随后由 15 名男性组成的队列每天摄入 5 盎司、10 盎司和 15 盎司的番茄大豆汁 (OSU-TSJ- 001）。男性将在接受前列腺切除术前 28 天食用番茄大豆营养品。目标 1. 我们假设男性会愿意食用没有剂量限制性毒性的番茄大豆营养品 (OSU-TSJ-001)。历史表明，确定毒性和安全性的努力至关重要。目标 2. 我们假设食用番茄大豆营养品 (OSU-TSJ-001) 将导致番茄大豆植物化学物质在血液和前列腺组织中的生物分布呈剂量依赖性增加。目标 3. 我们假设食用番茄大豆营养品 (OSU-TSJ-001) 会改变血液荷尔蒙模式和氧化应激生物标志物，从而有利于预防前列腺癌。目标 4. 我们将研究与前列腺癌发生相关的组织病理学和分子生物标志物，这些标志物可作为替代终点生物标志物，并提供有关其受番茄大豆营养品 (OSU-TSJ-001) 调节能力的信息。意义。拟议的研究代表了在针对前列腺癌的临床试验中评估含有番茄和大豆成分的新型“功能性食品”/营养保健品的首次尝试。我们的目标是开发番茄大豆汁，用于未来评估前列腺癌预防或改善癌症治疗（预防复发或改善激素、生物或化学治疗的结果）的大规模随机试验。 I / II 期研究提供了重要的安全性和有效性数据，以及有关番茄-大豆植物化学物质的吸收和生物分布的有价值的信息，以及与作用机制相关的替代终点生物标志物的表征，这些信息可能在未来的随机临床试验中有用。

项目成果

期刊论文数量（2）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

A combination of tomato and soy products for men with recurring prostate cancer and rising prostate specific antigen.

番茄和豆制品的组合，适用于患有复发性前列腺癌和前列腺特异性抗原升高的男性。

DOI：
发表时间：
2008
期刊：
影响因子：
0
作者：
Grainger, Elizabeth M;Schwartz, Steven J;Wang, Shihua;Unlu, Nuray Z;Boileau, Thomas W;Ferketich, Amy K;Monk, J Paul;Gong, Michael C;Bahnson, Robert R;DeGroff, Valerie L;Clinton, Steven K
通讯作者：
Clinton, Steven K

A Novel Tomato-Soy Juice Induces a Dose-Response Increase in Urinary and Plasma Phytochemical Biomarkers in Men with Prostate Cancer.

一种新型番茄大豆汁可引起前列腺癌男性尿液和血浆植物化学生物标志物的剂量反应增加。

DOI：
10.1093/jn/nxy232
发表时间：
2018-11-24
期刊：
The Journal of nutrition
影响因子：
0
作者：
E. Grainger;Nancy E. Moran;D. Francis;S. Schwartz;L. Wan;J. Thomas;R. Kopec;K. Riedl;G. Young;R. Abaza;R. Bahnson;S. Clinton
通讯作者：
S. Clinton