One-Stop prostate cancer diagnosis: new device combines MRI and biopsy
NCT ID NCT05362032
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new device called OmnEcoil can safely and effectively combine two separate prostate cancer tests—MRI and biopsy—into a single procedure. About 45 men aged 45 and older with elevated PSA or abnormal exams will participate. The goal is to see if this approach simplifies diagnosis and provides clear tissue samples for cancer detection.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
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Other studies related to the condition(s) this trial covers.
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