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MRI watch may cut unnecessary prostate biopsies

NCT ID NCT07332832

Diagnosis Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will follow 1,000 men with suspicious prostate lesions using yearly MRI scans and regular PSA blood tests. The goal is to see if changes in MRI images can help decide when a biopsy is truly needed, potentially avoiding unnecessary procedures. Researchers will track how often significant prostate cancers are found and whether this monitoring strategy is safe and effective over time.

What this could mean

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

Active substance
Bi-parametric MRI and PSA test
What this could lead to
If successful, this approach could help doctors decide when to biopsy, avoiding unnecessary procedures and improving prostate cancer detection.
What could go wrong
This is an early observational study, not a treatment trial. The strategy may not reduce biopsies or miss some cancers, and results may not apply to all patients.

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.

Participants

About 1,000 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

May 2029

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.

Who is studied

Patients with clinical suspicion of prostate cancer presenting to Peking University First Hospital and Shanghai East Hospital (Affiliated to Tongji University)

Ages

18 to 85 years

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: * Aged 18 to 85 years. * Total PSA (tPSA) level ranging from 3 ng/ml to 20 ng/ml (inclusive). * Underwent prostate MRI at the study institution with complete imaging sequences. * Capable of providing written informed consent. * Patients with PI-RADS 4-5, or PI-RADS 3 combined with PSAD ≥ 0.2 ng/ml², who have undergone prostate biopsy with no diagnosis of clinically significant prostate cancer (csPCa). * Biopsy-naïve patients with PI-RADS 2, or PI-RADS 3 combined with PSAD \< 0.2 ng/ml². Exclusion Criteria: * Pathologically confirmed diagnosis of clinically significant prostate cancer (csPCa). * Contraindications to prostate biopsy or inability to tolerate the procedure. * Current use of 5-alpha reductase inhibitors (5-ARIs). * History of hip replacement, metallic hip arthroplasty, or extensive pelvic orthopedic surgery with metallic hardware, or presence of other implants that would degrade MRI image quality. * Contraindications to bi-parametric MRI (bpMRI) (e.g., severe claustrophobia, cardiac pacemakers).

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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 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 ↗

  2. 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.

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