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 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT00584532
Eligibility Criteria:
Inclusion Criteria:
* Participants must be male and have a pathological diagnosis of prostate cancer
* Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.
* No treatment (surgery, radiation, or hormones) prior to study entry.
* PSA between 2.0 and 10.0 ng/ml.
* If PSA is \>10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.
* No known allergy to soy or soy products.
* The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).
* Participant has not been on any previous GCP clinical trial.
* Normal Chemistry values prior to study entry.
Exclusion Criteria:
* No pathological documentation of prostate cancer.
* Prior treatment for prostate cancer.
* PSA \>10.0 ng/ml but not on Active Surveillance for 12 months.
* Allergy to soy or soy products.
* Abnormal chemistry values.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00584532
Study Brief:
Protocol Section:
NCT00584532