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

  • Not Yet Recruiting
  • Observational
  • Diagnostic Test
  • Specialty Networks Research.
  • 21 Years -


Study Purpose

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.

Intervention

Diagnostic Test : PYLARIFY


Eligibility Requirements

info icon Patients must meet all the following inclusion criteria:

info icon Biological male at birth ≥ 21 years of age

info icon Histopathological confirmed prostate adenocarcinoma

info icon 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

info icon Life expectancy ≥ 6 months as determined by the investigator

info icon Able and willing to provide informed consent and comply with the protocol requirements.

info icon Patients meeting any of the following exclusion criteria are not eligible for enrollment in this study:

info icon Patients who are referred for PSMA PET and undergo a PSMA PET with a radioactive agent other than PYLARIFY

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

info icon 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.

Recruiting status

Not Yet Recruiting

Estimated enrollment

500

 
Study start date

Feb 28, 2023

Study end date

Jun 30, 2029

Last updated

Mar 24, 2025

Primary purpose

N/A

Design

Observational

Intervention

Diagnostic Test

Study phase

N/A

Allocation

N/A

 

Sponsor:

Specialty Networks Research.

Collaborator:

Lantheus Medical Imaging

Investigator:

N/A

NCT05712473

Clinic Location Investigator Distance RECRUITING STATUS Contact