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

NCT ID: NCT05712473

Last Updated: 2023-02-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2029-06-30

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

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

PYLARIFY

Intervention Type: DIAGNOSTIC_TEST

PYLARIFY PET

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

PYLARIFY

Intervention Type: DIAGNOSTIC_TEST

PYLARIFY PET

Interventions

PYLARIFY

PYLARIFY PET

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: collaborator

Specialty Networks Research.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lorraine ODonnell

Role: CONTACT

lorraine.odonnell@ppsanalytics.com

19143884907

Other Identifiers

SN-403

Identifier Type: -

Identifier Source: org_study_id