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New PET scan could spot leftover prostate cancer after targeted treatment

NCT ID NCT07568756

Diagnosis Sponsor: University of California, Irvine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial will test whether a special PET scan using Flotufolastat F18 can accurately detect any remaining prostate cancer after focal therapy (like cryotherapy or HIFU). About 60 men with prostate cancer who haven't had prior treatment will get the scan before and after their focal therapy. The results will be compared to standard MRI and biopsy to see if the PET scan is a reliable way to confirm successful treatment.

What this could mean

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

Active substance
Flotufolastat F18 (a radioactive tracer used in PET scans)
What this could lead to
If successful, this could provide a more accurate way to check if focal therapy has fully treated prostate cancer, potentially reducing the need for repeat biopsies.
What could go wrong
This is a small, early-phase study (60 participants) focused on diagnostic accuracy, not treatment. The tracer may not prove reliable enough to replace current methods, and results may not apply to all prostate cancer 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

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

Expected to start

May 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.

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: * Age 18 years or greater at time of consent * Prostate adenocarcinoma (no other histologic subtypes allowed) * Prostate Cancer planned to be treated by focal therapy (e.g. cryotherapy, HIFU, or NanoKnife) * Multiparametric-MRI imaging planned * Planned pre- and post- treatment MRI-fusion biopsy Exclusion Criteria: * Prior treatment for any prostate malignancy (e.g. radiation, focal therapy, or systemic therapy) * Genomic classifiers (e.g. Decipher) signifying intermediate or high-risk disease * PSA \>10 * High-risk prostate cancer (diagnosed by biopsy) * Bilateral prostatic lobe disease

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate adenocarcinoma Prostate cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

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