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

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: PYLARIFY

• Registration Number: NCT05712473
• Lead Sponsor: PPsanalytics

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-01-25
• Last Update Submitted: 2023-01-25
• Study Start: 2023-02
• Study First Posted: 2023-02-03
• Last Update Posted: 2023-02-03
• Primary Completion: 2028-12
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	PYLARIFY	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
Cohort 2:	PYLARIFY	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

Primary Outcome Measures

Name	Time	Method
Primary Objective	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Secondary Objective 2	5 years	To understand the impact of PYLARIFY PET results on healthcare resource utilization.
Secondary Objective 3	5 years	To understand the role of PYLARIFY PET in treatment change management for newly diagnosed prostate cancer patients.
Secondary Objective 1	5 years	To understand the demographic and clinical characteristics of patients referred for PYLARIFY PET.
Secondary Objective 5	5 years	To understand racial and ethnic disparities in prostate cancer care.
Secondary Objective 4	5 years	To understand the utilization of PYLARIFY PET at very low PSA levels in patients with oligometastatic prostate cancer.