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Which PET tracer shows prostate cancer recurrence better?

NCT ID NCT06604442

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study compared two radioactive tracers, piflufolastat (18F) and flotufolastat (18F), used in PET scans to detect prostate cancer that has returned after surgery. The main goal was to see which tracer produces less radioactivity in the bladder, which can interfere with image clarity. The study involved 62 men with low PSA levels (≤0.5 ng/mL) and a history of prostate cancer recurrence after radical prostatectomy.

What this could mean

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

Active substance
piflufolastat (18F) and flotufolastat (18F) (radioactive tracers for PET scans)
What this could lead to
If successful, this could help doctors choose the PET tracer that gives clearer images of recurrent prostate cancer, potentially improving detection.
What could go wrong
This is a small, completed Phase 4 study focused on comparing bladder radioactivity, not on patient outcomes. The results may not change clinical practice or directly improve survival.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

62 people

The number who actually took part.

Started

Dec 2024

Finished

Aug 2025

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: * Male ≥18 years of age at Visit 1 (Screening). * Documented history of localized adenocarcinoma of the prostate with prior curative intent treatment with RP and undetectable PSA post-surgery, experiencing BCR of prostate cancer. * At least 6 months must have elapsed after RP. * Low PSA BCR defined as PSA ≤0.5 ng/mL. * Scheduled by their treating physician to receive a PSMA (18F) PET scan. * Written informed consent obtained from the patient and ability for the patient to comply with the requirements of the study. Exclusion Criteria: * Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements. * Patients who are planned to have an x-ray contrast agent or any other PET radiotracer within 24 hours prior to either PSMA PET scan. * Patients who have already received a piflufolastat (18F) PET scan prior to providing informed consent for this study. * Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to either of the PSMA PET scans in this study. * Patients with known hypersensitivity to the active substance or to any of the excipients of piflufolastat (18F) or flotufolastat (18F). * Patients who have previously undergone a cystectomy or have renal failure, or have other conditions that may significantly affect urinary output, as judged by the investigator. * Patients who have already received salvage therapy.

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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.

Prostate cancer

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Endeavor Health- Glenbrook Hospital

    Glenview, Illinois, 60026, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • XCancer Omaha/Urology Cancer Center

    Omaha, Nebraska, 68130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.