A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Prostate
18 Years
N/A
Male
Prostate Cancer
Trial Information
A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Prostate
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Meets one of the following criteria:
- Abnormal digital rectal examination or abnormal prostate specific antigen (> 4.0
ng/mL)
- Obstructing prostate
- Biopsy-proven prostate cancer
- Scheduled to undergo prostate surgery (i.e., transurethral prostatectomy or
prostatectomy)
PATIENT CHARACTERISTICS:
- No uncontrolled diabetes, uncontrolled blood pressure, chronic congestive heart
failure, or history of renal insufficiency
- No personal or family history of a bleeding disorder
- No known history of problems absorbing dietary fats (e.g., Crohn's disease, cystic
fibrosis)
PRIOR CONCURRENT THERAPY:
- More than 2 weeks since prior NSAIDs or corticosteroids
- No concurrent supplementation of vitamin E (a multivitamin containing ≤ 60 IU of
vitamin E is allowed)
- No concurrent colestipol or orlistat
- No concurrent warfarin or dicumarol
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E2
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Susan Goodin, PharmD, FCCP, BCOP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Institutional Review Board
Study ID:
120802
NCT ID:
NCT00895115
Start Date:
April 2009
Completion Date:
May 2012
Related Keywords:
- Prostate Cancer
- prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
