PROSTATE CANCER AND PSA RECURRENCE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 食用十字花科蔬菜与较低的前列腺癌发病率和死亡率有关，在体外，吲哚芥菜素和ITCs可诱导细胞凋亡并降低PSA的表达6。然而，食用十字花科蔬菜对人体PSA水平的影响尚不清楚，也不知道前列腺癌患者是否会保持饮食或补充方案。补充I3C可能更容易被患者接受，但同样，对PSA的影响尚不清楚。我们的长期目标是确定I3C补充剂或食用十字花科蔬菜是否可以防止前列腺癌患者的PSA复发。为了开展这样的试验，我们提出了一项初步的三臂盲法试验，将66名PSA复发的前列腺切除术患者随机分为1)白菜类蔬菜(每天2份)、2)I3C(每天400 mg)或3)安慰剂(每天1份)。这项试验的目的包括：1)确定在该患者群体中摄入Brassica和使用I3C补充剂的可行性；2)确定不良事件(AE)；以及3)量化每种干预措施对PSA的影响。将在基线、基线后2个月、4个月和6个月收集饮食、AE评估以及血液和尿样。我们假设80%的受试者会坚持所有的干预目标，不常见且仅有轻微的不良反应。此外，我们假设，与I3C补充剂或安慰剂相比，摄入Brassica后PSA水平会更低。这项可行性试验将确定这些患者是否会增加蔬菜摄入量或遵守补充方案以及Brassica植物化学物质对PSA的影响，从而导致PSA复发预防试验。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Brassica consumption is associated with lower prostate cancer incidence and mortality, and Brassica indoles and ITCs induce apoptosis and decrease PSA expression in vitro 6. However, the effect of Brassica intake on human PSA levels is unknown, and it is not known if prostate cancer patients will maintain a diet or supplement protocol. I3C supplementation may be more acceptable to patients, but again, the effects on PSA are unknown. Our long-term goal is to determine if I3C supplements or Brassica consumption could prevent a PSA recurrence among prostate cancer patients. Toward developing such a trial, we propose a preliminary 3-armed, blinded trial randomizing 66 prostatectomy patients with PSA recurrence to 1) Brassica vegetables ( 2 servings/day), 2) I3C (400 mg/day), or 3) Placebo (1/day). The aims of this trial include: 1) determine the feasibility of Brassica intake and I3C supplement use in this patient population, 2) identify adverse events (AE), and 3) quantify the effects of each intervention on PSA. Diet, AE assessment, and blood and urine specimens will be collected at Baseline, and at 2-months, 4-months, and 6-months post-Baseline. We hypothesize that > 80% of subjects will adhere to all intervention goals, with infrequent and only mild AEs. Furthermore, we hypothesize that PSA levels will be lower with Brassica intake compared to I3C supplements or Placebo. This feasibility trial will determine if these patients will increase vegetable intake or adhere to supplement protocols and the effects of Brassica phytochemicals on PSA, leading to a PSA recurrence prevention trial.