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Can a special PET scan change the course of prostate cancer?

NCT ID NCT05712473

Diagnosis Sponsor: Lantheus Medical Imaging 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are running a registry to see how a PET scan using PYLARIFY (piflufolastat F18) affects real-world care for men with prostate cancer. The study will follow 500 men for up to 5 years, collecting data every 6 months on their diagnosis, treatment, and outcomes. The goal is to understand whether the scan helps doctors make better decisions and how it influences the use of healthcare resources.

What this could mean

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

Active substance
Piflufolastat F18, a radioactive tracer used in PET scans to highlight prostate cancer cells
What this could lead to
If the scans prove useful, doctors could rely on them more often to spot where prostate cancer has spread and to choose the right treatment.
What could go wrong
This is an observational registry, so it cannot prove that the scans cause better outcomes. It only tracks what happens in routine practice, and results may not apply to all patients.

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 500 people

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

Started

May 2023

Expected to finish

May 2031

An estimate. End dates often move.

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.

Who is studied

Biologically male patients with confirmed prostate cancer referred to undergo a PSMA PET with PYLARIFY.

Ages

21 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: Patients must meet all the following inclusion criteria: 1. Biological male at birth ≥ 21 years of age 2. Histopathological confirmed prostate adenocarcinoma 3. Patients meeting the enrollment criteria for either Cohort 1 or Cohort 2: 1. Cohort 1: Patients who are newly diagnosed with prostate cancer (and have suspected metastases per the physician's discretion per standard of care assessment) and have not yet initiated any prostate cancer treatment and are referred to undergo PYLARIFY PET for identification of suspected metastases. OR 2. Cohort 2: Patients who have previously received treatment for prostate cancer and are referred to undergo PYLARIFY PET or have received PYLARIFY PET for suspected recurrence of prostate cancer (based on an elevated PSA) within 60 days of consent to enroll in the registry 4. Life expectancy ≥ 6 months as determined by the investigator 5. Able and willing to provide informed consent and comply with the protocol requirements. Exclusion Criteria: Patients meeting any of the following exclusion criteria are not eligible for enrollment in this study: 1. Patients who are referred for PSMA PET and undergo a PSMA PET with a radioactive agent other than PYLARIFY 2. Patients who have histological evidence of neuroendocrine prostate cancer (NEPC) (small cell/ductal variant) 3. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety of compliance of the patient to produce reliable data or completing the study.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma 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

  • Adult & Pediatric Urology

    Omaha, Nebraska, 68114, United States

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Comprehensive Urology

    Royal Oak, Michigan, 48076, United States

  • Comprehensive Urology Medical Group

    Los Angeles, California, 90048, United States

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17604, United States

  • Pasadena Urological Medical Group

    Pasadena, California, 91101, United States

  • Potomac Urology

    Alexandria, Virginia, 22311, United States

  • Urology Associates Nashville

    Nashville, Tennessee, 37209, United States

  • Urology Associates of Central California

    Fresno, California, 93720, United States

  • Urology Centers of Alabama

    Homewood, Alabama, 35209, United States

  • Urology of St. Louis

    St Louis, Missouri, 63141, United States

  • Urology of Virginia

    Virginia Beach, Virginia, 23462, United States

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