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Which biopsy method finds prostate cancer best? major trial launches

NCT ID NCT06517901

Diagnosis Sponsor: Albany Medical College 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to use MRI images during prostate biopsy: software fusion (computer-assisted) and cognitive fusion (doctor's visual estimate). Over 1,300 men with suspicious prostate lesions will be randomly assigned to one method. The goal is to see which technique detects clinically significant prostate cancer more accurately.

What this could mean

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

What this could lead to
If one method proves better, it could become the standard way to diagnose prostate cancer, leading to more accurate detection and fewer unnecessary biopsies.
What could go wrong
This is a diagnostic comparison, not a treatment trial. Even if one method is better, it won't cure or prevent cancer. Results may not apply to all men or settings.

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 1,306 people

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

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

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: * Men undergoing prostate biopsy (either transrectal or transperineal) for suspected prostate cancer as part of their regular medical care * Must be eligible to undergo both prostate biopsy procedure (cognitive or fusion) * Men undergoing their first prostate biopsy procedure or with no previous prostate biopsy within 3 years * Pre-biopsy mp-MRI of prostate with one or more lesions classified as PIRADS 3-5 * Largest dimension of any lesion on mp-MRI to be ≤ 2 cm * Prostate-specific antigen level ≤ 20 ng/mL and/or abnormal digital rectal examination Exclusion Criteria: * mp-MRI detected lesions that are \> 2 cm * History of prostate biopsy within 3 years * Previous diagnosis of prostate cancer * Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities as per treating physician)

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Conditions

The condition(s) this trial relates to.

disease neoplasm prostate cancer

As listed by the trial registrant

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

Diagnosis Prostate cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Lahey Clinic, Inc

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Manitoba Prostate Centre, CancerCare Manitoba

    NOT_YET_RECRUITING

    Winnipeg, Manitoba, R3A 1M5, Canada

  • Pennsylvania State University

    NOT_YET_RECRUITING

    Hershey, Pennsylvania, 17023, United States

    Contact Email: •••••@•••••

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