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Fewer needles, same safety? new study tests smarter prostate cancer detection.

NCT ID NCT07516223

Diagnosis Sponsor: Shanghai East Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether men with very high PSA and suspicious MRI can safely skip the painful 12-needle systematic biopsy and rely only on targeted samples. Over 1,200 men will get both biopsies, but each sample is analyzed separately to see how often the extra needles find dangerous cancers the targeted ones missed. If the extra needles find less than 5% of cancers, doctors may change guidelines to spare men unnecessary pain, bleeding, and infection risk.

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 successful, this could prove that many men with high PSA and suspicious MRI can skip the painful 12-needle systematic biopsy, reducing complications and costs.
What could go wrong
This is a diagnostic study, not a treatment trial. It may show that systematic biopsy is still needed for some men, or the 5% threshold might not be met, meaning no change in practice.

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 1,235 people

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

Started

Apr 2026

Expected to finish

May 2028

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

45 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: Age ≥ 45 years. Serum PSA level ≥ 4.0 ng/ml. High-risk MRI findings: Presence of at least one lesion with a PI-RADS score of 4 (Likely) or 5 (Highly Likely) according to v2.1 guidelines11. Fitness for transperineal prostate biopsy under local or general anaesthesia. Competency to provide informed consent. Exclusion Criteria: History of prior prostate biopsy (to ensure baseline risk homogeneity). Prior treatment for prostate cancer or use of 5-alpha reductase inhibitors (5-ARIs) within 6 months. Candidates who have explicitly opted for focal therapy prior to biopsy (where systematic mapping remains mandatory). Contraindications to MRI (e.g., incompatible implants, severe renal impairment). Active urinary tract infection or acute prostatitis.

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Conditions

The condition(s) this trial relates to.

pleomorphic adenoma prostate cancer

As listed by the trial registrant

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

PSA PSA progression

How to take part

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

  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

  • Shanghai east hospital

    RECRUITING

    Shanghai, China

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