Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT00809458
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00809458
Study Brief:
Protocol Section:
NCT00809458