New imaging agent aims to unmask hidden prostate cancer recurrences

NCT ID NCT06813898

Diagnosis Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This trial tests whether a special PET/CT scan using a tracer called POSLUMA can detect prostate cancer in men whose PSA levels are rising after treatment but who had negative results on standard PET scans. The study enrolls men with biochemical recurrence and low PSA levels. Researchers will compare the scan findings to tissue samples or follow-up imaging to see how often POSLUMA spots cancer that other scans missed.

What this could mean

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

Active substance: Flotufolastat F-18 Gallium (POSLUMA)
What this could lead to: If successful, this imaging method could help doctors find hidden prostate cancer recurrences earlier, guiding more precise treatment.
What could go wrong: This is an early-phase trial with only 27 participants, so results may not apply broadly. The scan might still miss some cancers or find false positives.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 27 people

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

Started

Apr 2025

Expected to finish

Feb 2032

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy \[i.e. salvage radiation\]) * Men must have biochemical recurrence (defined as PSA \>= 0.1ng/ml) after therapy * PSA \< 0.5ng/ml (within 90 days of enrollment) * Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer * Non-castrate testosterone (testosterone \[T\] \> 50ng/dL) within 90 days of study entry * Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study * Concurrent diseases and malignancies are permitted Exclusion Criteria: * Most recent PSA not between 0.1ng/ml and 0.5ng/ml * Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \< 50ng/dl) * Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma

As listed by the trial registrant

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

Biochemically recurrent prostate carcinoma Prostate adenocarcinoma

How to take part

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

The places running it

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

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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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.

New imaging agent aims to unmask hidden prostate cancer recurrences

What the study statuses mean