NCT05712473Active, not recruiting
An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
A Prospective Observational Multicenter Real-World Registry Assessing the Impact of the Use of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 25 Jan 2023
- Start date
- 22 May 2023
- Primary completion date
- Feb 2031
- Lead sponsor
- Lantheus Medical Imaging
- Diseases
- Prostate cancer
- NCT number
- NCT05712473
What you commit to
- Study type: Observational
- Planned participants: 500
- From 22 May 2023 to the primary completion date, Feb 2031
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients 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.
Other
- 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 PYLARIFY
Who the study is looking for
- Patients must meet all the following inclusion criteria:
- Biological male at birth ≥ 21 years of age
- Histopathological confirmed prostate adenocarcinoma
- Patients 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.
- OR
- 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
- Life expectancy ≥ 6 months as determined by the investigator
- Able and willing to provide informed consent and comply with the protocol requirements.
Age in the registry: 21 years to - · Sex: Male · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Potomac Urology Coordinator of this site? Confirm its status | Alexandria | United States | Unknown status |
| Urology Associates of Central California Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Urology Centers of Alabama Coordinator of this site? Confirm its status | Homewood | United States | Unknown status |
| Keystone Urology Specialists Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Arkansas Urology Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Comprehensive Urology Medical Group Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Urology Associates Nashville Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Adult & Pediatric Urology Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Pasadena Urological Medical Group Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Comprehensive Urology Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Urology of St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Urology of Virginia Coordinator of this site? Confirm its status | Virginia Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.