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AI reads scans to spot prostate cancer, spare unnecessary biopsies

NCT ID NCT07690306

Diagnosis Sponsor: Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study aims to develop an artificial intelligence (AI) model that combines two advanced imaging techniques—multiparametric MRI and PSMA PET/CT—to more accurately diagnose prostate cancer. By analyzing data from up to 1,500 patients, the AI model is designed to identify clinically significant cancers while reducing false positives that lead to unnecessary biopsies. The goal is to help doctors make better decisions without invasive procedures.

What this could mean

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

Active substance
Artificial intelligence diagnostic model
What this could lead to
If successful, this AI model could make prostate cancer diagnosis more accurate and less invasive, reducing the need for unnecessary biopsies.
What could go wrong
This is a retrospective study using existing data, so the AI model may not perform as well in real-world settings. It is still in the development and validation phase.

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 1,500 people

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

Started

Jan 2026

Expected to finish

Dec 2026

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

This study will enroll patients who underwent mpMRI, PSMA PET/CT, and prostate biopsy or radical prostatectomy at six major hospitals in China: Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Chinese PLA General Hospital, The First Affiliated Hospital of Guangzhou Medical University, Beijing Hospital and Renji Hospital, Shanghai Jiao Tong University School of Medicine. The study population includes two groups: patients with pathologically confirmed prostate cancer (cases) and patients with pathologically confirmed benign prostatic hyperplasia (BPH, controls). All participants are male, aged 18 years or older, with no prior prostate cancer treatment (endocrine therapy or radiotherapy) or prostate surgery. Patients with severe renal insufficiency or other malignancies are excluded. A total of approximately 1,000 to 1,500 participants will be enrolled retrospectively from the participating centers.

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: 1. Age ≥ 18 years. 2. ECOG performance status 0-2. 3. Life expectancy \> 6 months. 4. Underwent mpMRI and PSMA PET/CT before systemic treatment or radical prostatectomy, with original DICOM data available for export. 5. Has pathological diagnosis from prostate biopsy or radical prostatectomy as the gold standard. 6. Complete clinical data available, including pre-treatment PSA (tPSA, fPSA), TNM stage, Gleason score, PI-RADS score, SUVmax, prostate volume (from MRI/PSMA PET), age, and BMI. 7. Informed consent for data use for research purposes according to each center's ethics requirements. Exclusion Criteria: 1. History of other malignant tumors 2. Previous prostate surgery (e.g., TURP) 3. Prior endocrine therapy or radiotherapy 4. Severe renal insufficiency 5. Major organ dysfunction or life expectancy \< 1 year

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia disease prostate cancer

As listed by the trial registrant

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

Prostate cancer (diagnosis)

How to take part

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

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200127, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

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