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Active, not recruitingNCT05712473Updated Sep 15, 2026

An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer

An observational study in Prostate Cancer, sponsored by Lantheus Medical Imaging. Active, not recruiting at 12 sites in United States. Open to male participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Lantheus Medical Imaging · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
21 Years and older
Sex
Male
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Study summary

The goal of this observational research is to assess the real-world clinical utility of PYLARIFY PET through evaluation of long-term outcomes for prostate cancer patients who are eligible for a PSMA/PET scan.

Participants will be enrolled at their physician's office at the time of referral for PYLARIFY PET and will be followed for up to 5 years. Data concerning their prostate cancer diagnostics and treatment will be collected at 6-month intervals.

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Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Lantheus Medical Imaging is the lead sponsor of 30 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Cohort 1

    Patients who are newly diagnosed with prostate cancer (and have suspected metastases) and have not yet initiated any prostate cancer treatment and are referred to undergo PYLARIFY PET

    Diagnostic Test: PYLARIFY

  • 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

    Diagnostic Test: PYLARIFY

Interventions

  • Diagnostic testPYLARIFY

    PYLARIFY PET

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What researchers measure

Primary outcomes

  1. Primary Objective

    The objective of this registry is to assess the real-world clinical utility of PYLARIFY PET through evaluation of long-term outcomes for prostate cancer patients who are eligible for a PSMA/PET scan and for whom PYLARIFY imaging is incorporated into treatment recommendations and management plans.

    Time frame: 5 years

Secondary outcomes

  1. Secondary Objective 1

    To understand the demographic and clinical characteristics of patients referred for PYLARIFY PET.

    Time frame: 5 years

  2. Secondary Objective 2

    To understand the impact of PYLARIFY PET results on healthcare resource utilization.

    Time frame: 5 years

  3. Secondary Objective 3

    To understand the role of PYLARIFY PET in treatment change management for newly diagnosed prostate cancer patients.

    Time frame: 5 years

  4. Secondary Objective 4

    To understand the utilization of PYLARIFY PET at very low PSA levels in patients with oligometastatic prostate cancer.

    Time frame: 5 years

  5. Secondary Objective 5

    To understand racial and ethnic disparities in prostate cancer care.

    Time frame: 5 years

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Study locations

12 sites
  • Urology Centers of Alabama
    Homewood, Alabama 35209, United States
  • Arkansas Urology
    Little Rock, Arkansas 72211, United States
  • Urology Associates of Central California
    Fresno, California 93720, United States
  • Comprehensive Urology Medical Group
    Los Angeles, California 90048, United States
  • Pasadena Urological Medical Group
    Pasadena, California 91101, United States
  • Comprehensive Urology
    Royal Oak, Michigan 48076, United States
  • Urology of St. Louis
    St Louis, Missouri 63141, United States
  • Adult & Pediatric Urology
    Omaha, Nebraska 68114, United States
  • Keystone Urology Specialists
    Lancaster, Pennsylvania 17604, United States
  • Urology Associates Nashville
    Nashville, Tennessee 37209, United States
  • Potomac Urology
    Alexandria, Virginia 22311, United States
  • Urology of Virginia
    Virginia Beach, Virginia 23462, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05712473
Lead sponsor
Lantheus Medical Imaging
Collaborators
Specialty Networks Research.
Responsible party
Sponsor
First posted
Feb 3, 2023
Start date
May 22, 2023
Primary completion
Feb 2031 (estimated)
Completion
May 2031 (estimated)
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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