Clinical trial NCT05712473: An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Specialty Networks Research.
Sponsor class: NETWORK
Collaborators: name: Lantheus Medical Imaging
First posted: 2023-02-03
Enrollment: 500
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biologically male patients with confirmed prostate cancer referred to undergo a PSMA PET with PYLARIFY.

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.


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.

Primary outcomes:
measure: Primary Objective
timeFrame: 5 years
Secondary outcomes:
measure: Secondary Objective 1
timeFrame: 5 years
measure: Secondary Objective 2
timeFrame: 5 years
measure: Secondary Objective 3
timeFrame: 5 years
measure: Secondary Objective 4
timeFrame: 5 years
measure: Secondary Objective 5
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References: