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New imaging agent may reveal hidden prostate cancer recurrence

NCT ID NCT05588128

Diagnosis Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 11 times

Summary

This study is testing whether a radioactive tracer called 18F-DCFPyL, used during a PET/CT scan, can better detect where prostate cancer has returned in men whose PSA levels are rising after initial treatment. About 350 men will be followed for up to 5 years with regular scans and blood tests. The goal is to see if this imaging method can find cancer that standard scans miss.

What this could mean

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

Active substance
18F-DCFPyL (a radioactive tracer used for PET imaging)
What this could lead to
If successful, this could lead to a more accurate way to find recurrent prostate cancer, helping doctors decide on the best treatment sooner.
What could go wrong
This is an observational study, not a treatment trial. The tracer may not detect all cancer sites, and results may not change patient outcomes.

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 350 people

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

Started

Mar 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Primary clinical

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: * History of primary treatment for prostate cancer (either surgery or radiation) * Serum PSA \>= 0.50 * Serum testosterone \>100 * Age \>=18 years * Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable * The ability of a participant to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA: -Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \[MRI\] as clinically indicated). NOTE: Lymph nodes \<= 1.5 cm in the shortest dimension are allowed. * Evidence of bone lesions on Tc99 bone scan * Prostatectomy within 1 year before the study intervention * Androgen deprivation therapy (ADT) within the 6 months before the study intervention * Systemic therapy for prostate cancer within the 6 months before the study intervention. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed.

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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.

Biochemically recurrent Prostate cancer

How to take part

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

  1. The places running it

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

  2. 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 ↗

  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

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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