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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT00978718
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Clinical indicators consistent with the community standards of medical care that would justify a biopsy of the prostate for the diagnosis of cancer, including ≥ 1 of the following:
* PSA level above the absolute value of 4 ng/mL or above a published age-ethnic adjusted PSA level appropriate for the community
* Rising PSA that should represent a clinically significant PSA velocity (e.g., an estimated annual change in the PSA velocity ≥ 0.75 ng/mL)
* Abnormal digital rectal examination of the prostate that identifies a clinically significant change in the prostate (e.g., a prostate nodule or a change in the firmness of the prostate)
* Documentation of the clinical assessment that justified the prostate biopsy that allows classification of the patient to high-risk groups
* Prostate biopsy negative for cancer within the past 12 months
* Prostate biopsy negative for high-grade prostatic intraepithelial neoplasia (PIN)
* PIN allowed provided it is grade 1
PATIENT CHARACTERISTICS:
* Creatinine \< 2 times upper limit of normal (ULN)
* Bilirubin \< 2 times ULN
* SGOT and SGPT \< 2 times ULN
* Alkaline phosphatase \< 2 times ULN
* No history of a prior malignancy except for the following:
* Adequately treated basal cell or squamous cell carcinoma
* Adequately treated (i.e., complete surgical removal with negative margins) stage I cancer from which the patient is currently in complete remission
* Any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior systemic chemotherapy or radiotherapy
* At least 90 days since prior and no other concurrent selenium \> 55 μg/day as a dietary supplement (including multivitamin supplements)
* More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modifications, exercise)
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
79 Years
Study:
NCT00978718
Study Brief:
Protocol Section:
NCT00978718