A Prospective Observational Multicenter Real-World Registry Assessing the Impact of the Use of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
Study Identifier:
SN-403
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Will Be Recruiting
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Study 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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Prostate
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
IV
Sex
Male
Age
21+ years
Study Drug
Drug: Cohort 1
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting
Requirements information
Inclusion criteria
- Inclusion Criteria:
- Patients must meet all the following inclusion criteria:
- Biological male at birth ≥ 21 years of ageHistopathological confirmed prostate adenocarcinomaPatients meeting the enrollment criteria for either Cohort 1 or Cohort 2: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.ORCohort 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 registryLife expectancy ≥ 6 months as determined by the investigatorAble and willing to provide informed consent and comply with the protocol requirements.
Exclusion criteria
- Exclusion Criteria:
- Patients meeting any of the following exclusion criteria are not eligible for enrollment in this study:
- Patients who are referred for PSMA PET and undergo a PSMA PET with a radioactive agent other than PYLARIFYPatients who have histological evidence of neuroendocrine prostate cancer (NEPC) (small cell/ductal variant)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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Neal Shore
Status
Recruitment Complete
Condition(s) Treated at Site
Prostate