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Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer

NCT00809458 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-07-16

Study results available
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Summary

The purpose of this study is to find out if vitamin E can help treat prostate cancer. Vitamin E acts primarily as an anti-oxidant. By decreasing the oxidation in the cancer cell, the tumor cells may die. Vitamin E is a commonly used vitamin that has not been approved by the Food and Drug Administration for use in this type of cancer or for any known cancer. This study will test the hypothesis that vitamin E, in the setting of an oxidative stress such as smoking, can reduce prostate cancer related biomarkers in patients with localized prostate cancer in the neoadjuvant setting.

Conditions

Interventions

DRUG

Vitamin E

Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.

Sponsors & Collaborators

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Ian Rabinowitz, M.D. · University of New Mexico Cancer Center

  • Richard Lauer, MD · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-05-31
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00809458 on ClinicalTrials.gov