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Can a wider biopsy needle sharpen prostate cancer diagnosis?

NCT ID NCT06830265

Diagnosis Sponsor: Uro-1 Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

Prostate biopsies can misjudge cancer severity up to 40% of the time. This trial tests a new needle that collects more tissue than standard ones, aiming to give pathologists a clearer sample. Researchers will compare tissue amount and quality from both needles in 200 men with suspicious MRI findings. They will also check if computer analysis of the samples matches traditional pathology readings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A novel needle biopsy catheter that captures more prostate tissue than standard needles
What this could lead to
If the new needle collects more and better-quality tissue, it could make prostate cancer grading more accurate and reduce misdiagnosis.
What could go wrong
The trial is early and measures tissue quality, not patient outcomes. The new needle may not improve diagnosis enough to replace standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult males with PSA density greater than or equal to 0.15 * Lesions are visible under MRI * PIRADS score is greater than or equal to 3 * Able to and willing to provide consent Exclusion Criteria: * Subject has had previous local prostate therapy, focal therapy, brachytherapy, ADT, surgery, or chemotherapy for prostate cancer * History of dementia, cognitive impairment, or deep vein thrombosis (DVT) * Is a prisoner currently or has a history of incarceration * Unable to understand English * Has metastatic prostate cancer or a tumor stage of T2c, T3, or T4 * Has concurrent malignancies * Is positive for HIV, HBV, and/or HCV infection * Has low-performance status

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer screening

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • NYU Langone

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • Novant Health Coastal Carolina Medical Center

    RECRUITING

    Hardeeville, South Carolina, 29927, United States

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