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New PET tracer could reveal hidden prostate cancer

NCT ID NCT04457232

Diagnosis Sponsor: Jonsson Comprehensive Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests a new imaging agent called 68Ga-FAPI-46, which targets a protein (FAP) found around tumor cells. Researchers want to see where this tracer goes in the body and whether it can highlight prostate cancer on PET scans. About 30 people with prostate cancer who are already scheduled for surgery or biopsy will receive the tracer and undergo imaging. The goal is to compare the scan results with tissue samples to see if the tracer accurately identifies cancer.

What this could mean

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

Active substance
a radioactive tracer called gallium Ga 68 FAPi-46
What this could lead to
If successful, this imaging method could help doctors better detect and understand prostate cancer, leading to more precise diagnosis and treatment planning.
What could go wrong
This is an early, small study focused on imaging, not treatment. The tracer may not reliably distinguish cancer from normal tissue, 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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

Sep 2020

Expected to finish

May 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.

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: * Patients who underwent a 68Ga-PSMA-11 PET/CT scan within 3 months of enrollment * Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion * Patients can provide written informed consent * Patients are able to remain still for duration of imaging procedure (up to one hour) Exclusion Criteria: * Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor (FAPI) PET/CT

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

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

Metastatic malignant neoplasm in the prostate gland Prostate carcinoma Recurrent prostate carcinoma

Contacts and locations

Locations

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095, United States

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