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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT00482157
Eligibility Criteria:
Inclusion Criteria:- Untreated prostate adenocarcinoma by an extended biopsy (\>8 needle cores on systematic prostate biopsy) within 1 year of the screening date
* PSA \<10.0 ng/ml
* Gleason sum 6 or \<2 mm Gleason pattern 4
* No more than 33% of biopsy cores positive Exclusion Criteria:- Prior or concurrent treatment for prostate cancer
* Use of Finasteride, Dutasteride, Saw Palmetto
* Use of NSAIDs, COX-2 inhibitors and/or aspirin, soy or vitamin D supplements for more than 7 days over the one month prior to study
* Kidney disease, hypercalcemia or renal stones
* ECOG performance status \>1
* Uncontrolled hypertension, unstable angina, history of transient ischemic attack (TIA), history of stroke.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT00482157
Study Brief:
Protocol Section:
NCT00482157