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:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT00082732
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* No small cell component
* No histologically confirmed and/or demonstrable metastatic or locally recurrent disease by bone scan, chest x-ray, computed tomography (CT) scan, or transrectal ultrasound
* No clinical symptoms within the past 90 days
* Documented biochemical failure after radical prostatectomy
* Prostate-specific antigen must have initially nadired to an undetectable level (\< 0.1 ng/mL) after prostatectomy AND is currently rising (0.3-40.0 ng/mL)
* Serum testosterone \> 100 ng/dL
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Zubrod 0-1
Life expectancy
* At least 1 year
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* No known allergic reactions to milk or soy products
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* More than 1 year since prior chemotherapy
Endocrine therapy
* More than 1 year since prior hormonal therapy
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00082732
Study Brief:
Protocol Section:
NCT00082732