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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT05362032
Eligibility Criteria:
Inclusion Criteria:
* Males, aged \>= 45 years
* Willing and able to provide written informed consent, including willingness to undergo MRI-targeted biopsy using OmnEcoil investigational system
* Persistently elevated (\> 3 ng/mL) or rising prostate specific antigen (PSA) level and/or abnormal digital rectal exam
* Prior negative transrectal ultrasound (TRUS) biopsy, or prior TRUS biopsy or transurethral resection of the prostate showing Gleason score =\< 6 disease
* Received multiparametric prostate MRI within last 6 months prior to study enrollment with images available on Oregon Health and Science University (OHSU) image viewing system for review
* Must have at least one high-value biopsy target (i.e., score of 4 or 5 as categorized by Prostate Imaging and Reporting and Data System \[PI-RADS\] version 2.1) present on multiparametric MRI as evaluated by study radiologists
* Eastern Cooperative Group (ECOG) performance score 0 or 1
* Patient able to lie prone in MRI for OmnEcoil biopsy procedure
* Considered to be low bleeding risk \[per Society for Interventional Radiology\], including:
* International normalized ratio (INR) \<= 1.5, and
* Platelets \>= 50,000
Exclusion Criteria:
* Contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, and cardiac pacemaker)
* Any contraindication to endorectal devices and/or biopsy, including (but not limited to) severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection
* Any bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily reversed
* Active infection requiring systemic antibiotic therapy. Participants requiring systemic antibiotics for infection must have completed antibiotic therapy before initiating OmnEcoil imaging/biopsy procedure
* Administration of treatment for prostate cancer such as radiation or hormonal therapy prior to MRI-targeted biopsy
* Uncontrolled intercurrent illness that would substantially increase risk of incurring adverse events (AEs), confound results, or compromise the ability of the patient to give written informed consent
* Subjects unwilling to accept a blood transfusion
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT05362032
Study Brief:
Protocol Section:
NCT05362032