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Trial Title:
An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
NCT ID:
NCT05712473
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PYLARIFY
Description:
PYLARIFY PET
Arm group label:
Cohort 1
Arm group label:
Cohort 2:
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.
Criteria for eligibility:
Study pop:
Biologically male patients with confirmed prostate cancer referred to undergo a PSMA PET
with PYLARIFY.
Sampling method:
Non-Probability Sample
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.
Gender:
Male
Gender based:
Yes
Gender description:
Registry is specifically for prostate cancer patients (limited to biologically male).
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 2023
Completion date:
June 2029
Lead sponsor:
Agency:
Specialty Networks Research.
Agency class:
Other
Collaborator:
Agency:
Lantheus Medical Imaging
Agency class:
Industry
Source:
Specialty Networks Research.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05712473
