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New scan could reveal hidden spread of prostate cancer

NCT ID NCT06074510

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing whether a special PET scan using PYLARIFY can find prostate cancer that has spread beyond the prostate in men with favorable intermediate risk cancer. About 274 men will receive one injection and scan, then be followed for up to a year. The goal is to see if the scan detects cancer that other tests miss, which could help guide treatment.

What this could mean

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

Active substance
Piflufolastat F 18 (PYLARIFY injection)
What this could lead to
If successful, this could help doctors more accurately determine if prostate cancer has spread, leading to better treatment choices for men with favorable intermediate risk prostate cancer.
What could go wrong
This is a phase 4 imaging study, not a treatment trial. It may not change outcomes for all patients, and false positives or negatives are possible. Results are limited to detection, not cure.

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

About 274 people

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

Started

Feb 2024

Expected to finish

Sep 2026

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.

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. Patients must have the ability to understand and sign an approved informed consent form (ICF) 2. Patients must have the ability to understand and comply with all protocol requirements 3. Patients must be ≥ 18 years of age 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5. Patients with life expectancy of at least 13 months as determined by the investigator 6. Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following: * 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL) * ISUP Grade Group 1 or 2 * \<50% biopsy cores positive (e.g., \<6 of 12 cores) Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging Exclusion Criteria: 1. Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging) 2. Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy 3. Known hypersensitivity to the components of PYLARIFY or its analogs 4. Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study 5. Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)

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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

  • BAMF Health

    Grand Rapids, Michigan, 49503, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hoag Cancer Center

    Irvine, California, 92618, United States

  • Huntsman Cancer Institute University of Utah

    Salt Lake City, Utah, 84112, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Karmanos Cancer Institute Wayne State University

    Detroit, Michigan, 48201, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Tower Urology

    Los Angeles, California, 90048, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Iowa Health Care

    Iowa City, Iowa, 52242, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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