• Reduce biomarkers of prostate cancer [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of VE supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.
  
  

• Determine the tolerability/toxicity of a short course of vit. E in the neoadjuvant setting. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  1. Cardiovascular Effects/ Thrombophlebitis
  2. Dermatologic Effects
  3. Gastrointestinal Effects (Gingival bleeding, and gastrointestinal irritations including: diarrhea, nausea, flatulence and stomach cramps)
  4. Hematologic Effects (Increased bleeding tendencies in vitamin K deficient patients; inhibition of prothrombin production
  5. Hepatic Effects (Vasculopathic hepatotoxicity and cholestasis)
  6. Neurologic Effects (Dizziness, headache, fatigue or weakness
  7. Ophthalmic Effects ( Blurred vision)
  8. Respiratory Effects (Pulmonary embolism)
  
  
• Determine concordance of the biomarkers in this setting [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  The correlation between the ATQ level and the androgen receptor will be explored.
  
  

Drug: Vitamin E
Patients will take one 400 IU tablet of vitamin E 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.
Other Name: Alpha-tocopherol (α-tocopherol)

- Prostate Cancer

Prostate cancer is the most common malignancy in American men. It is estimated that nearly 235,000 men in the United States will be diagnosed with prostate cancer and nearly 27,000 men will die of prostate cancer in 2006 (Ries, 2006). The treatment of localized prostate cancer includes surgery, radiation therapy, or watchful waiting. The relative benefits of these approaches is unclear and treatment choices are individualized and often patient driven. Approximately 150 prostatectomies are performed at UNM and the Albuquerque NM VA HEALTH CARE SYSTEM annually. A further 50 brachytherapies are performed at UNM. There is currently no proven benefit to receiving preoperative hormonal therapy for patients undergoing radical prostatectomy. As opposed to patients undergoing external beam radiation therapy, for patients undergoing brachytherapy pre treatment hormonal therapy is used in ~40% of patients. Thus, these patients offer a unique opportunity to test novel agents in the neoadjuvant setting.

- Vitamin E

The term vitamin E was introduced by Evans and Bishop to describe a dietary factor important for reproduction in rats (Evans, 1922). Natural vitamin E includes two groups of closely related fat-soluble compounds, the tocopherols and tocotrienols, each with the four , ß, , and analogs. The eight analogous compounds are widely distributed in nature; rich, natural sources of vitamin E are edible plant oils. Sunflower seeds contain almost exclusively -tocopherol, oil from soybeans contains the -, -, and -tocopherol, and palm oil contains high concentrations of tocotrienols and -tocopherol (Bauernfeind,1980). Although the antioxidant property of these molecules is similar, distinct biological effects can be distinguished at a molecular level. Vitamin E is the major hydrophobic chain-breaking antioxidant that prevents the propagation of free radical reactions in the lipid components of membranes, vacuoles and plasma lipoproteins.

As an antioxidant, vitamin E acts in cell membranes where it prevents the propagation of free radical reactions. Non-radical oxidation products are formed by the reaction between alpha-tocopheryl radical and other free radicals, which are conjugated to glucuronic acid and excreted through the bile or urine. Vitamin E is transported in plasma lipoproteins.

Most studies of the safety of vitamin E supplementation have lasted for several months or less, so there is little evidence for the long-term safety of vitamin E supplementation. The Food and Nutrition Board of the Institute of Medicine has set an upper tolerable intake level (UL) for vitamin E at 1,000 mg (1,500 IU) for any form of supplementary alpha-tocopherol per day. Based for the most part on the result of animal studies, the Food and Nutrition Board decided that because vitamin E can act as an anticoagulant and may increase the risk of bleeding problems this is the highest dose unlikely to result in bleeding problems (http://dietary-supplements.info.nih.gov/factsheets/vitamine.asp).

The dose of vitamin E used in the Selenium and vitamin E prostate cancer prevention trial (the SELECT trial) was 400 IU per day and thus this is the dose chosen for this study.