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

Launched by SPECIALTY NETWORKS RESEARCH. · Jan 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well a special type of imaging scan called PYLARIFY PET can help doctors understand and treat prostate cancer in real-world settings. It aims to gather information about the long-term outcomes for patients who are eligible for this scan. If you are a biological male aged 21 or older with confirmed prostate cancer, you may qualify to participate. There are two groups of patients who can enroll: one group consists of newly diagnosed patients who haven't started treatment yet, and the other group includes patients who have already received treatment and are being checked for signs of cancer returning.

If you join the study, you will be followed for up to five years, and your doctors will collect information about your prostate cancer diagnosis and treatment every six months. The trial is not yet recruiting participants, but it’s important to know that you will need to provide informed consent and meet certain health criteria to ensure your safety throughout the study. This research could contribute valuable insights into how PYLARIFY PET can improve care for men with prostate cancer.

Gender

MALE

Eligibility criteria

• 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:
• 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.