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


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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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 SchoolNew Brunswick, New Jersey  08903