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AI could slash unnecessary prostate biopsies in 'Gray Zone' patients

NCT ID NCT07631806

Diagnosis Sponsor: Guangxi Medical University 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an artificial intelligence system that combines blood tests, lab data, and ultrasound images to better diagnose prostate cancer in men with borderline PSA levels (4-10 ng/mL). The goal is to reduce unnecessary biopsies by accurately identifying who truly has cancer. The trial involves 500 men in China and uses biopsy results as the gold standard to measure the AI's accuracy.

What this could mean

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

Active substance
AI-assisted diagnostic system (combines ctDNA liquid biopsy, lab data, and ultrasound images)
What this could lead to
If successful, this could provide a more accurate, non-invasive way to diagnose prostate cancer in men with borderline PSA levels, reducing unnecessary biopsies.
What could go wrong
This is an early-stage validation study at a single hospital, so results may not apply to other populations. The AI system's accuracy depends on the quality of data and may still miss some cancers.

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 500 people

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

Started

May 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.

Who is studied

The study population consists of male patients aged ≥45 years with suspected prostate cancer, presenting with abnormal serum PSA (≥4 ng/mL), abnormal digital rectal examination, or suspicious lesions on prostate ultrasound, who are scheduled to undergo prostate biopsy. Participants will be prospectively enrolled from patients presenting to the hospital for PSA abnormality, lower urinary tract symptoms, or active screening. The total planned sample size is no less than 500 cases, divided into a training set (approximately 400 cases) and a validation set (approximately 100 cases) at an 8:2 ratio. Excluded are patients with prior diagnosis of prostate cancer receiving active treatment, those with other malignancies, and those with critical missing clinical data.

Ages

45 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Age ≥45 years, male 2. Presenting with abnormal serum PSA (≥4 ng/mL), abnormal digital rectal examination, or suspicious lesions on prostate ultrasound 3. Undergoing prostate biopsy with definitive pathological results 4. Signed informed consent Exclusion Criteria: 1. Previously diagnosed with prostate cancer and receiving surgery, radiotherapy, or endocrine therapy 2. With other malignancies 3. Critical missing clinical data (e.g., missing PSA value, incomplete ultrasound report)

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Conditions

The condition(s) this trial relates to.

disease prostate cancer

As listed by the trial registrant

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

Prostate cancer with PSA gray zone

Contacts and locations

Locations

  • Guangxi Medical University First Affiliated Hospital

    Nan'ning, Guangxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.