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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00064194
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed high-grade prostatic intraepithelial neoplasia (HGPIN)
* No evidence of invasive prostate cancer by at least 2 biopsies within the past 18 months
* At least 1 biopsy must show evidence of HGPIN within the past 6 months
* No prior invasive prostate cancer
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Not specified
Life expectancy
* More than 5 years
Hematopoietic
* Platelet count at least 75,000/mm\^3
* No coagulopathies
Hepatic
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* PT (INR) no greater than 1.5 times ULN
* PTT no greater than 1.5 times ULN
* No hepatic insufficiencies
Renal
* Creatinine no greater than 2 times ULN
* No renal insufficiencies
Other
* No prior nonmelanoma skin cancer (e.g., squamous cell or basal cell carcinoma)
* No other malignancy within the past 5 years except superficial bladder cancer
* No known bowel malabsorption
* No dietary behavior (e.g., morbid obesity or eating disorders) that would limit adherence to study therapy
* No major illness, including psychiatric illness, that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 3 months since prior androgen therapy
* More than 3 months since prior hormonal therapy for benign prostatic hyperplasia (e.g., finasteride)
* No concurrent finasteride
* No concurrent androgen therapy
Radiotherapy
* More than 2 years since prior radiotherapy to the pelvic region
Surgery
* Not specified
Other
* More than 2 weeks since prior supplemental vitamin E or selenium
* No other concurrent vitamin E (greater than 100 IU/day), selenium, or soy protein isolate (more than 2 servings/week)
* No other concurrent treatment for high-grade prostatic intraepithelial neoplasia
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
120 Years
Study:
NCT00064194
Study Brief:
Protocol Section:
NCT00064194