Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer



Status:Archived
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:April 2009

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A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Prostate


RATIONALE: Vitamin E supplements may stop or delay the development of prostate cancer in
patients who are at risk of prostate cancer or who have prostate cancer. It is not yet known
which vitamin E regimen is more effective in preventing prostate cancer.

PURPOSE: This randomized phase I trial is comparing vitamin E supplement regimens to see how
well they work in preventing cancer in patients at risk of prostate cancer or who have
prostate cancer.


OBJECTIVES:

- Determine the effect of tocopherol supplementation on plasma and urine levels of α-,
γ-, and δ-tocopherols, PSA, and prostaglandin E_2 by comparing the blood and urine
samples collected before and after the supplementation in patients with prostate
cancer.

- Test the hypothesis that the supplementation reduced oxidative and nitrosative stress
by measuring plasma levels of F_2-isoprostane, C-reactive protein, and 3-nitrotyrosine
as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG).

- Determine the levels of α-, γ-, and δ-tocopherols in prostate tissues and analyze
immunohistochemically (IHC) for cell proliferation, apoptosis, cyclooxygenase-2,
8-OHdG, and 3-nitropyrosine levels in prostate cancer/tissue slides.

OUTLINE: Patients are randomized into 1 of 3 arms.

- Arm I: Patients receive no supplementation.

- Arm II: Patients receive oral high γ-tocopherol vitamin E supplementation once daily
for 1 week.

- Arm III: Patients receive oral high γ-tocopherol vitamin E supplementation once daily
for 2 weeks.

Blood, urine, and tissue samples are collected periodically and analyzed for
oxidative/nitrosative stress and other markers (i.e., F2-isoprostane, 8-OHdG,
3-nitrotyrosine, prostaglandin E2, C-reactive protein, and PSA), biomarkers in prostate
tumors and nontumorous tissues (i.e., 8-OHdG, 3-nitrotyrosine, and cyclooxygenase-2) by IHC,
and pharmacokinetics by high-performance liquid chromatography.


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