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Can fewer prostate biopsy cores catch cancer just as well?

NCT ID NCT07795723

Diagnosis Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether taking biopsy samples from only the side of the prostate where an MRI shows a suspicious lesion can match the standard approach of sampling both sides. Men with suspected prostate cancer and a single MRI lesion will be randomly assigned to receive either the targeted biopsy plus a 6-core biopsy on the same side, or the targeted biopsy plus a standard 12-core biopsy on both sides. The main question is whether the one-sided approach detects clinically significant prostate cancer just as well, while potentially reducing pain, procedure time, and complications.

What this could mean

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

Active substance
MRI/ultrasound cognitive fusion targeted biopsy combined with either ipsilateral or bilateral systematic biopsy
What this could lead to
If fewer biopsy cores detect cancer just as well, men could face less pain, fewer complications, and lower costs during prostate cancer diagnosis.
What could go wrong
The trial is early and noninferiority is not guaranteed. Taking fewer samples might miss some cancers, and results may not apply to all men.

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 454 people

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

Started

Jul 2026

Expected to finish

Apr 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

19 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: * Male participants older than 18 years. * Suspected prostate cancer and scheduled to undergo transperineal prostate biopsy. * Prostate MRI showing a unilateral lesion with a highest Prostate Imaging Reporting and Data System (PI-RADS) score of 4 or 5. * Serum prostate-specific antigen (PSA) level of 20 ng/mL or lower. * Able to tolerate and undergo transperineal prostate biopsy. * Willing to participate in the study and able to provide written informed consent. Exclusion Criteria: * Prior prostate biopsy. * Prior prostate-related treatment or procedure that may affect pathological assessment or interpretation of the biopsy results, including but not limited to androgen deprivation therapy for prostate cancer, radiotherapy, focal therapy, or transurethral prostate surgery. * Prostate MRI showing a lesion crossing the prostatic midline such that the lesion side cannot be clearly determined, or an independent contralateral lesion with a PI-RADS score of 3 or higher. * Acute urinary tract infection, severe coagulation disorder, or any other contraindication to transperineal prostate biopsy. * In the investigator's judgment, inability to understand the study, comply with study procedures, or provide written informed consent.

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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

How to take part

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  1. The places running it

    1 site. 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

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    RECRUITING

    Nanjing, Jiangsu, China

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