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Does Protein Restriction Inhibit Prostrate Cancer Growth

2021年3月24日 更新者:Washington University School of Medicine

The Purpose of the Protein Study is to investigate whether a reduced protein diet can inhibit the growth of prostate cancer in humans.

The Investigators hypothesis is that a reduced protein diet will inhibit expression of genes that are involved in the growth of prostate cancer.

研究概览

地位

完全的

条件

详细说明

The primary objective of this study is to determine whether or not a low protein diet has an inhibitory effect on prostate cancer cell growth.

The primary outcome measures relative to the investigators primary objectives are:

For Group 1 the expression of genes and proteins of the PI-3K/Akt/mTOR pathway. For Group 2 the PSA values obtained every three months.

研究类型

介入性

注册 (实际的)

65

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

group 1

  1. Patient must have a diagnosis of prostate cancer confirmed by pathology.
  2. Patient must be scheduled to undergo radical prostatectomy no sooner than 6 weeks from date of enrollment (to allow for a minimum of 4 weeks on the low protein diet).
  3. Patient must have adequate baseline protein intake (screening 4-day food record shows protein > 1.0 g/kg FFM)
  4. Patient must be able to understand the English-language instructions.
  5. Patient must be able to comply with the low protein diet (as evaluated by the dietitian and other study team members).
  6. Patient must be able to understand and willing to sign an IRB-approved written informed consent document.

5.2.2 Inclusion Criteria - Group 2

  1. Patient must have a diagnosis of prostate cancer.
  2. Patient must have previously undergone a radical prostatectomy for treatment of prostate cancer.
  3. Patient must have a detectable PSA (defined as PSA ≥ 0.1) in at least two consecutive measurements, taken at least one month apart, with no therapy between the PSA measurements. If the patient has had additional therapy after the radical prostatectomy, there must be evidence of a rising PSA (i.e., two consecutive measurements at least one month apart) after the patient has completed the intervening therapy (meaning that the patient must have failed treatment).
  4. Patient must have adequate baseline protein intake (screening 4-day food record shows protein > 1.0 g/kg FFM).
  5. Patient must have adequate baseline caloric intake (screening 4-day food record shows caloric intake of > 1500 kcal/day).
  6. Patient must be able to understand the English-language instructions.
  7. Patient must be able to comply with the low protein diet (as evaluated by the dietitian and other study team members).
  8. Patient must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

  1. Patient must not currently be receiving any therapy for prostate cancer.
  2. Patient must not have any serious chronic illness such as unstable angina, any uncontrolled metabolic disorder, or any immunologic disorder.
  3. Patient must not have a history of any previous malignancy (with the exception of squamous or basal cell carcinoma of the skin) in the 5 years prior to enrollment (for Group 1) or 12 months prior to enrollment (for Group 2).
  4. Patient must not have a previous history of a stroke.
  5. Patient must not be taking any medications that might confound the study results (anabolic agents (such as androgen, androgen precursor, rhGH) in the 6 months prior to enrollment; corticosteroids (other than nasal) in the 6 months prior to enrollment; or finasteride or dutasteride).
  6. Patient must not have dementia or any other cognitive impairment.
  7. Patient must not have a lifestyle or fixed diet pattern that would interfere with participation in or interpretation of the results of this study

    -

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control
No changes in dietary group
实验性的:Protein restrictive diet
reduced protein diet
To begin a reduced protein diet

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Group1--Expression of genes and proteins of the PI-3K/Akt/mTOR pathway. Group 2--PSA values obtained every three months
大体时间:group 1- (4-6 weeks), group 2 -(52 weeks)
The investigators will be looking at the increase or decrease of PSA values between control and protein restricted diet participants obtained for the length of study.
group 1- (4-6 weeks), group 2 -(52 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Valeria Tosti, MD、Washington University School of Medicine
  • 首席研究员:Luigi Fontana, MD,PhD、Washington University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2011年1月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2012年9月7日

首先提交符合 QC 标准的

2012年9月20日

首次发布 (估计)

2012年9月25日

研究记录更新

最后更新发布 (实际的)

2021年3月26日

上次提交的符合 QC 标准的更新

2021年3月24日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Plan to publish

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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