Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Vitamin E
Intervention description: 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.
Intervention MeSH terms: Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin E; Prostate Cancer; Alpha-tocopherol (α-tocopherol)

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.
    

Eligibility 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.