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Could a simple scan replace the needle? new study tests Real-Time prostate cancer diagnosis

NCT ID NCT07709403

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study explores whether measuring radioactive counts from PSMA PET/CT-guided biopsy samples can instantly tell if a tissue core contains cancer. Researchers aim to find a cutoff value that reliably distinguishes cancerous from non-cancerous tissue, using standard pathology as the gold standard. If successful, this could reduce the need for multiple biopsy cores and eventually lead to a non-invasive, biopsy-free diagnosis of prostate cancer.

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 pave the way for a non-invasive, biopsy-free diagnosis of prostate cancer using imaging alone.
What could go wrong
This is a small, early-stage study with only 20 participants, so results may not apply broadly. The technique may not reliably replace traditional biopsies.

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 20 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 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.

Who is studied

Patients undergoing prostate biopsy at Peking University First Hospital due to suspected prostate cancer and meeting eligibility criteria

Ages

18 to 80 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: * Age 18-80 years; * Meeting clinical indications for prostate biopsy (serum PSA persistently \>4 ng/mL, and at least one lesion with PI-RADS ≥ 3 on magnetic resonance imaging \[MRI\]); * At least one suspicious lesion detected on PSMA PET/CT; * No prior prostate biopsy Exclusion Criteria: * Prior chemotherapy, pelvic radiotherapy, or androgen deprivation therapy (ADT) for prostate cancer; * Prior prostate surgery (transurethral resection of the prostate, etc.); * Any contraindications to prostate biopsy, such as active urinary tract infection or indwelling urinary catheter; * Biopsy core data with failed gamma spectrometer measurement due to technical reasons.

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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

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

  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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