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New PET tracer could spot hidden prostate cancer spread

NCT ID NCT03173924

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This study compares a new radioactive tracer called 18F-DCFPyL with standard tracers to see if it can better detect where prostate cancer has spread in the body. About 96 men with metastatic prostate cancer will receive both tracers and undergo PET/CT scans. The goal is to measure how accurately the new tracer identifies cancer sites, which could improve treatment planning.

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 for PET scans)
What this could lead to
If successful, this could lead to a more accurate imaging method for finding prostate cancer spread, helping doctors choose better treatments.
What could go wrong
This is a small, early-phase study focused on imaging accuracy, not treatment. The new tracer may not prove significantly better than existing methods.

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

96 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Feb 2028

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.

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 greater than or equal to 18 years old * Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2. * Ability of subject to understand and the willingness to sign a written informed consent document. * Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater. OR Documented history of metastatic prostate cancer. * Patients must be co-enrolled on a UOB, GMB or ROB protocol * Histological confirmation of prostate cancer * Patients must be willing to undergo mandatory research biopsy EXCLUSION CRITERIA: * Subjects for whom participating would significantly delay the scheduled standard of care therapy. * Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results. * Subjects with severe claustrophobia unresponsive to oral anxiolytics * Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for protocol procedures. * Subjects weighing greater than 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry * Serum creatinine greater than 2 times the upper limit of normal

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Conditions

The condition(s) this trial relates to.

disease metastatic prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

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

Metastatic prostate cancer Prostate cancer Prostate neoplasms Prostatic cancer Prostatic neoplasms

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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