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Sharper eye on prostate cancer: new imaging agent could spot recurrence early

NCT ID NCT04186845

Diagnosis Sponsor: Blue Earth Diagnostics 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026

Summary

This phase 3 study tested a new radioactive imaging agent, rhPSMA-7.3 (18F), in 391 men with suspected prostate cancer recurrence after initial treatment. The agent is used during a PET scan to highlight cancer cells. The goal was to see how well it detects where the cancer has returned. Results could lead to more accurate diagnosis and better salvage therapy planning.

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 (rhPSMA-7.3) injection
What this could lead to
If successful, this imaging agent could help doctors more accurately detect where prostate cancer has returned, guiding better treatment decisions.
What could go wrong
This is a diagnostic study, not a treatment. The agent may not detect all recurrences, and false positives are possible. Results need confirmation in broader practice.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

391 people

The number who actually took part.

Started

May 2020

Finished

Apr 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Patient is male and aged \>18 years old. 2. History of localized adenocarcinoma of the prostate with prior curative intent treatment. 3. An elevated PSA, clinically suspicious for biochemically recurrent disease: * Following Radical Prostatectomy: PSA \>0.2 ng/mL * Following Radiotherapy: nadir +2 ng/mL. 4. Potentially eligible for salvage therapy with curative intent. Exclusion Criteria: 1. Patients who are planned to have an x-ray contrast agent or other PET radiotracer \<24 hours prior to the PET scan. 2. Patients currently receiving Androgen Deprivation Therapy (ADT).

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Conditions

The condition(s) this trial relates to.

disease prostate cancer

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • CWZ

    Nijmegen, 6532, Netherlands

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27701, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • John Wayne Cancer Institute

    Santa Monica, California, 90403, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • MD Anderson Hospital

    Houston, Texas, 77054, United States

  • Maxima MC

    Veldhoven, 5504 DB, Netherlands

  • MidLantic Urology

    Philadelphia, Pennsylvania, 19004, United States

  • Montefiore Hospital

    The Bronx, New York, 10461, United States

  • Mount Sinai Faculty Practice Associates

    New York, New York, 10029, United States

  • Northshore University HealthSystem

    Evanston, Illinois, 60201, United States

  • Northside Hospital

    Austell, Georgia, 30342, United States

  • Queens Hospital Center (QHC - Queens Cancer Center

    Jamaica, New York, 11432, United States

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • Turku University Hospital

    Turku, FI-20520, Finland

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of California Irvine Medical Center (UCIMC)

    Orange, California, 92868, United States

  • University of Michigan Ann Arbor

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia - Health Science Center

    Charlottesville, Virginia, 22908, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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