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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05712473
• Other study ID #: SN-403
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: June 2029

Study information

• Verified date: January 2023
• Source: PPsanalytics
• Contact: Lorraine ODonnell
• Phone: 19143884907
• Email: lorraine.odonnell[@]ppsanalytics.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• PYLARIFY
PYLARIFY PET

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
PPsanalytics	Lantheus Medical Imaging

Outcome

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