Vitamin D Supplementation in Veterans with Early-Stage Prostate Cancer

维生素D促进前列腺癌(Pca)细胞分化，维持前列腺癌分化表型 并可诱导前列腺癌细胞死亡，增加维生素D 随着时间的推移，缺乏促进亚临床前列腺癌进展为临床疾病。这是特别的 与循环(血清)维生素D缺乏的男性有关[&lt；20 ng/ml 25(OH)D3]。这些 考虑因素支持使用维生素D3作为化学预防药物，特别是在患有 维生素D缺乏症。 我们假设，被诊断为低血糖的退伍军人每天服用维生素D3(4,000国际单位)一年。 风险，早期前列腺癌，有资格进行积极监测，且循环(血清)不足 维生素D[&lt；20 ng/ML 25(OH)D3]将：a)显著降低血清PSA水平。 登记受试者的数量，以及b)与其PCA病理的稳定或改善有关， 通过前列腺组织活检标本的组织学检查进行评估(Gleason评分和百分比 在研究结束时获得的)，作为他们对活动性疾病的标准医疗护理的一部分 监视系统。 这项VA Merit应用程序建议进行一项随机、安慰剂对照的临床研究，旨在 退伍军人早期补充维生素D3(4000IU/d)的疗效评价 前列腺癌，他们选择通过主动监测来监测自己的疾病(在考虑 最终治疗)，并缺乏循环(血清)维生素D[&lt；20 ng/ml 25(OH)D3]。主 这项拟议的临床研究的目标如下： 1)确定每天补充4,000国际单位维生素D3 12个月是否会导致 早期诊断为低危退伍军人血清PSA水平显著降低 选择接受疾病监测的PCA(Gleason评分d6，PSA D10，临床分期T1c或T2a) 通过积极监测至少一年，且循环(血清)维生素D缺乏[&lt；20 Ng/ML 25(OH)D3]。 2)通过分析前列腺组织活检来确定入伍退伍军人前列腺癌的病理状态 研究结束时的标本(Gleason评分和阳性活检百分比)，并通过比较 作为他们标准医疗保健的一部分，他们与参加这项研究之前获得的那些人一起接受治疗。 这些拟议研究的实施将使我们能够评估维生素D3 补充剂可作为一种化学预防方案用于诊断为低血糖的退伍军人。 风险、早期PCA，并为积极监测提供有用的补充。

Vitamin D promotes the differentiation of prostate cancer (PCa) cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical PCa to clinical disease. This is particularly relevant to men WHO ARE DEFICIENT IN CIRCULATING (SERUM) VITAMIN D [<20 NG/ML 25(OH)D3]. These considerations support the use of vitamin D3 as a chemopreventive agent, especially in SUBJECTS WITH HYPOVITAMINOSIS D. We hypothesize that a daily dose of vitamin D3 (4,000 IU) taken for one year by Veterans diagnosed with low- risk, early-stage PCa, who are eligible for active surveillance AND ARE DEFICIENT IN CIRCULATING (SERUM) VITAMIN D [<20 NG/ML 25(OH)D3]will: a) result in a measurable decrease of serum PSA levels in a significant number of enrolled subjects, and b) be associated with a stabilization or improvement of their PCa pathology, as assessed through histologic examination of prostate tissue biopsy specimens (Gleason score and percent of positive biopsies) obtained at the end of the study, as part of their standard medical care for active surveillance. This VA Merit application proposes to conduct a randomized, placebo-controlled clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with early-stage prostate cancer, who elect to have their disease monitored through active surveillance (before considering definitive therapy) AND ARE DEFICIENT IN CIRCULATING (SERUM) VITAMIN D [<20 NG/ML 25(OH)D3]. The main objectives of this proposed clinical study are as follows: 1) To determine whether a daily supplement of 4,000 IU of vitamin D3 taken for twelve months will result in a measurable and significant decrease of serum PSA levels in Veterans diagnosed with low-risk, early stage PCa (Gleason score d6, PSA d10, clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year AND ARE DEFICIENT IN CIRCULATING (SERUM) VITAMIN D [<20 NG/ML 25(OH)D3]. 2) To determine in enrolled Veterans the pathology status of their PCa by analyzing prostate tissue biopsy specimens at the end of the study (Gleason score and percentage of positive biopsies), and by comparing them with those obtained before enrollment in this study, as part of their standard medical care. The implementation of these proposed studies will allow us to assess whether vitamin D3 supplementation can be utilized as a chemopreventive regimen in Veterans diagnosed with low- risk, early stage PCa, and provide a useful addition to active surveillance.