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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000095-46
Application #
7375693
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
46
Fiscal Year
2006
Total Cost
$11,745
Indirect Cost
Name
Vanderbilt University Medical Center
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212
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