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NCT05712473Active, not recruiting

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

A Prospective Observational Multicenter Real-World Registry Assessing the Impact of the Use of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
25 Jan 2023
Start date
22 May 2023
Primary completion date
Feb 2031
Lead sponsor
Lantheus Medical Imaging
NCT number
NCT05712473

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 22 May 2023 to the primary completion date, Feb 2031
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients who have histological evidence of neuroendocrine prostate cancer (NEPC) (small cell/ductal variant)
  • 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.

Other

  • Patients meeting any of the following exclusion criteria are not eligible for enrollment in this study:
  • Patients who are referred for PSMA PET and undergo a PSMA PET with a radioactive agent other than PYLARIFY

Who the study is looking for

  • Patients must meet all the following inclusion criteria:
  • Biological male at birth ≥ 21 years of age
  • Histopathological confirmed prostate adenocarcinoma
  • Patients meeting the enrollment criteria for either Cohort 1 or Cohort 2:
    • 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
    • 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
  • Life expectancy ≥ 6 months as determined by the investigator
  • Able and willing to provide informed consent and comply with the protocol requirements.

Age in the registry: 21 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Potomac Urology
Coordinator of this site? Confirm its status
AlexandriaUnited StatesUnknown status
Urology Associates of Central California
Coordinator of this site? Confirm its status
FresnoUnited StatesUnknown status
Urology Centers of Alabama
Coordinator of this site? Confirm its status
HomewoodUnited StatesUnknown status
Keystone Urology Specialists
Coordinator of this site? Confirm its status
LancasterUnited StatesUnknown status
Arkansas Urology
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status
Comprehensive Urology Medical Group
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Urology Associates Nashville
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Adult & Pediatric Urology
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
Pasadena Urological Medical Group
Coordinator of this site? Confirm its status
PasadenaUnited StatesUnknown status
Comprehensive Urology
Coordinator of this site? Confirm its status
Royal OakUnited StatesUnknown status
Urology of St. Louis
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Urology of Virginia
Coordinator of this site? Confirm its status
Virginia BeachUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.