An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PYLARIFY.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 21 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Observational Multicenter Real-World Registry Assessing the Impact of the Use of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
Overview
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.
Interventions
- Diagnostic test PYLARIFY
PYLARIFY PET
Primary outcome measures
- Primary Objective [Time frame: 5 years]
Secondary outcome measures (5)
- Secondary Objective 1 [Time frame: 5 years]
- Secondary Objective 2 [Time frame: 5 years]
- Secondary Objective 3 [Time frame: 5 years]
- Secondary Objective 4 [Time frame: 5 years]
- Secondary Objective 5 [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05712473 · SN-403