Status:
TERMINATED
Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 d...
Detailed Description
\- Prostate Cancer Prostate cancer is the most common malignancy in American men. It was estimated that nearly 235,000 men in the United States would be diagnosed with prostate cancer and nearly 27,0...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed prostate cancer.
- Patients must have localized prostate cancer and have decided to undergo a prostatectomy or brachytherapy.
- Patient must not be taking supplemental vitamin E.
- Age \>18 years.
- Life expectancy of greater than 6 months.
- ECOG performance status =\< 2.
- 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
- Patients must have the ability to understand, and the willingness to sign a written informed consent document.
Exclusion
- Patients who have metastatic prostate cancer.
- Patients may not be receiving any other investigational agents.
- 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).
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vitamin E.
- 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.
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00809458
Start Date
September 1 2008
End Date
February 1 2013
Last Update
July 16 2015
Active Locations (1)
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1
University of New Mexico - Cancer Center
Albuquerque, New Mexico, United States, 87106