Prostate CancerNCT05712473
An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer
An observational study of Prostate Cancer, run by Lantheus Medical Imaging at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PYLARIFY
- How many people
- 500 participants
- Where
- 12 sitesUnited States
- Study dates
- 22 May 2023to May 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Biologically male patients with confirmed prostate cancer referred to undergo a PSMA PET with PYLARIFY.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Potomac Urology
Alexandria, Virginia, 22311
Urology Associates of Central California
Fresno, California, 93720
Urology Centers of Alabama
Homewood, Alabama, 35209
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
Arkansas Urology
Little Rock, Arkansas, 72211
Comprehensive Urology Medical Group
Los Angeles, California, 90048
Urology Associates Nashville
Nashville, Tennessee, 37209
Adult & Pediatric Urology
Omaha, Nebraska, 68114
Pasadena Urological Medical Group
Pasadena, California, 91101
Comprehensive Urology
Royal Oak, Michigan, 48076
Urology of St. Louis
St Louis, Missouri, 63141
Urology of Virginia
Virginia Beach, Virginia, 23462
About this study
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
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
- Being tested
- PYLARIFY
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYLARIFYDiagnostic test
PYLARIFY PET
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: PYLARIFY | |
| 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 Receives: Diagnostic Test: PYLARIFY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
The objective of this registry 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 and for whom PYLARIFY imaging is incorporated into treatment recommendations and management plans.
Measured: 5 years
Secondary outcomes (5)
Secondary Objective 1
To understand the demographic and clinical characteristics of patients referred for PYLARIFY PET.
Measured: 5 years
Secondary Objective 2
To understand the impact of PYLARIFY PET results on healthcare resource utilization.
Measured: 5 years
Secondary Objective 3
To understand the role of PYLARIFY PET in treatment change management for newly diagnosed prostate cancer patients.
Measured: 5 years
Secondary Objective 4
To understand the utilization of PYLARIFY PET at very low PSA levels in patients with oligometastatic prostate cancer.
Measured: 5 years
Secondary Objective 5
To understand racial and ethnic disparities in prostate cancer care.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start22 May 2023
- Primary completionFeb 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Specialty Networks Research.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712473
- Sponsor's protocol ID
- SN-403
- Status last verified
- Sep 2026
- First submitted
- 25 Jan 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05712473
- Acronym / sponsor ID
- SN-403
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Collaborators
- Specialty Networks Research.
- Study start
- 22 May 2023 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: PYLARIFYPatients 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 |
| Cohort 2: | – | Diagnostic Test: PYLARIFYPatients 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biologically male patients with confirmed prostate cancer referred to undergo a PSMA PET with PYLARIFY.
Key inclusion criteria (11 listed)
- Biological male at birth ≥ 21 years of age
- Histopathological confirmed prostate adenocarcinoma
- Patients meeting the enrollment criteria for either Cohort 1 or Cohort 2:
- 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
Key exclusion criteria (4 listed)
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PYLARIFYPYLARIFY PET | Diagnostic test | Cohort 1, Cohort 2: |
Primary outcome
Primary Objective
Time frame: 5 years
The objective of this registry 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 and for whom PYLARIFY imaging is incorporated into treatment recommendations and management plans.
5 secondary outcomes
Secondary Objective 1
Time frame: 5 years
Secondary Objective 2
Time frame: 5 years
Secondary Objective 3
Time frame: 5 years
Secondary Objective 4
Time frame: 5 years
Secondary Objective 5
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Lantheus Medical Imaging at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.