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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT00058266
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of localized prostate cancer
* Diagnosed within the past 6 months
* T1 or T2 disease
* Gleason score 5-8
* Prostate-specific antigen no greater than 20 ng/mL
* Radical prostatectomy planned
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* More than 2 years
Hematopoietic
* Hemoglobin greater than 9.0 g/dL
* Platelet count greater than 100,000/mm\^3
* Absolute neutrophil count greater than 1,000/mm\^3
Hepatic
* SGPT and SGOT less than 3 times normal
* Bilirubin less than 3 mg/dL (less than 1.5 times normal) (patients with an elevated bilirubin due to a familial defect in bilirubin metabolism will be considered on an individual basis)
Renal
* Creatinine less than 2.0 mg/dL
Cardiovascular
* No venous thrombosis within the past year
Other
* Patients must use effective barrier contraception
* No other medical condition that would preclude study therapy
* No known soy intolerance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* No concurrent hormonal therapy for prostate cancer
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Other
* No concurrent soy supplements
* No concurrent foods high in genistein
* No concurrent active therapy for neoplastic disorders
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00058266
Study Brief:
Protocol Section:
NCT00058266