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

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

1. Patients must have histologically or cytologically confirmed prostate cancer.

2. Patients must have localized prostate cancer and have decided to undergo a prostatectomy or brachytherapy.

3. Patient must not be taking supplemental vitamin E.

4. Age >18 years.

5. Life expectancy of greater than 6 months.

6. ECOG performance status =< 2.

7. Patients must have normal organ and marrow function as defined below:

• leukocytes >= 3,000/mcL

• absolute neutrophil count >=1,500/mcL

• platelets >=100,000/mcL

• total bilirubin within normal institutional limits

• AST/ALT =< 2.5 X institutional upper limit of normal

• creatinine =< 1.5 X normal institutional upper limit of normal

• INR =<1.4

• PTT =<1.4 X institutional upper limit of normal

8. Patients must have the ability to understand, and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who have metastatic prostate cancer.

2. Patients may not be receiving any other investigational agents.

3. Patients with a known bleeding diathesis or patients on therapeutic anticoagulation. (This does not include the use of aspirin but refers to warfarin, heparin, or low molecular weight heparins).

4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin E.

5. The patient may not receive a gonadotrophin release agonist (such as goserelin, or leuprolide), or an antiandrogen (such as bicalutamide, flutamide, or nilutamide) during the study.

6. Uncontrolled intercurrent illness that would limit compliance with study requirements.

• Inclusion of Women and Minorities

• Only men are eligible for this trial. Members of all races and ethnic groups are eligible for this trial.