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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02176902
Eligibility Criteria:
Inclusion Criteria:
* Patients sign the informed consent
* Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate
* Patient elects to undergo active surveillance
* Clinical stage T2c or less
* Gleason grade 3+4 or less
* PSA \< 25
* Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit
* Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study
* If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study
Exclusion Criteria:
* Diagnostic prostate biopsy with only 1 core with cancer and \< 5% of tissue from that core involved with cancer
* Patient has taken finasteride or dutasteride during the prior year
* Patient has taken fish oil during the prior 3 months
* Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
* Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year
* Patient has allergy to fish
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT02176902
Study Brief:
Protocol Section:
NCT02176902