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Participants will receive a single dose of 333 MBq (9 mCi) \[296 MBq-370 MBq (8 mCi - 10 mCi)\] PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours post-dosing

Piflufolastat F 18 Intravenous Solution [PYLARIFY]

Senior Clinical Trial Manager

Danett Reynolds

Gary Ulaner, MD

Shiblee Nomanee

Terry Williams

David Josephson, MD

Yana Skorobogatova

Lilja Solnes, MD

Michael Treacy

Ciprian Catana, MD

Yvette Walker

Andrei Purysko, MD

The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer.

Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan.

PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer

A Phase 4 Open-Label Multicenter Study of PYLARIFY® PET/CT or PET/MRI in Men With Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer

The proportion of participants with prostate cancer in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as assessed by pathology, or in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases, divided by the number of subjects who undergo a PYLARIFY PET scan

Intended medical management plan before and after PYLARIFY PET imaging

The percentage of participants with at least one true positive lesion identified on PYLARIFY PET imaging and confirmed by the truth standard. This measure includes patients in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as confirmed by pathology; or patients in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases as assessed by central readers and verified by the standard of truth.

The percentage of participants for whom there is a one-to-one correspondence on the same side between the location of at least one lesion outside of prostate capsule (extraprostatic extension, seminal vesicle invasion, pelvic lymph nodes, extrapelvic lymph nodes, extrapelvic bone or extrapelvic soft tissue lesion(s) identified on PYLARIFY PET/CT or PET/MR and the standard of truth.

The percentage of participants who undergo PYLARIFY PET imaging that identifies a lesion or lesions outside of the prostate capsule and have an established standard of truth. Positive predictive value does not require a one-to-one correspondence by lesion location but requires that the lesion and standard of truth be within the same anatomic region, including prostatic, pelvic, extra-pelvic or distant lesions.

Sensitivity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

Specificity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

Negative predictive value at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.

Lantheus Medical Imaging

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

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

PYLARIFY

Lorraine ODonnell

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.

Registry is specifically for prostate cancer patients (limited to biologically male).

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

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.

To understand the demographic and clinical characteristics of patients referred for PYLARIFY PET.

To understand the impact of PYLARIFY PET results on healthcare resource utilization.

To understand the role of PYLARIFY PET in treatment change management for newly diagnosed prostate cancer patients.

To understand the utilization of PYLARIFY PET at very low PSA levels in patients with oligometastatic prostate cancer.

To understand racial and ethnic disparities in prostate cancer care.

PPsanalytics

Androgens

Testosterone

2 MRIs and 2 Pylarify PSMA PET/CTs, occurring at mid-treatment and when testosterone level is 75% recovered or 12 months after androgen deprivation therapy (ADT), whichever comes first

Piflufolastat F18 will first be given intravenously over about 5 seconds.

Pylarify Piflufolastat Flourine-18 (18F-DCFPyL)

Sirisha Nandular, MD

Mary G Martin, RN

This is a voluntary research study to find out how using technology including advanced magnetic resonance imaging (MRI) and prostate-specific membrane antigen - positron emission tomography (PSMA-PET) scan imaging, in addition to combined prostate treatment using radiation therapy, brachytherapy (internal radiation treatment using small radioactive seeds placed inside the body) and androgen deprivation therapy (drug therapy to suppress hormones) can help doctors see, track and predict tumor response to treatment for prostate cancer patients. Participation in this study will consist of radiation planning and simulation, magnetic resonance imaging (MRI) and positron emission tomography and computed tomography scan (PET/CT). One MRI and PSMA PET/CT scan will be done prior to the start of first external beam radiation therapy (EBRT) fraction. At mid-treatment prior to the second brachytherapy fraction, an MRI and PSMA PET/CT will be done. A third scan will be performed after 75% testosterone recovery or 12 months post androgen deprivation therapy (ADT) \[whichever comes first\].

The goal of the study is to better understand how an individual tumor responds to radiation therapy and determine if advanced imaging can be used for prognostic purposes, especially to predict areas of local resistance and failure. The study population are patients with high risk prostate malignancy treated with a combination of external beam radiation therapy (EBRT)/brachytherapy (BT) and androgen deprivation therapy (ADT). Patients enrolled in this trial will undergo a pre-treatment MRI and PSMA PET/CT prior to the initiation of ADT and the first EBRT fraction, a mid-treatment MRI and PSMA PET/CT prior to second brachytherapy fraction, and a third MRI and PSMA PET/CT will be performed after 75% testosterone recovery or 12 months post-ADT (whichever comes first). The pre-treatment MRI and PSMA PET/CT is part of standard of care for prostate cancer workup, however all additional MRI and PSMA PET/CT mid-treatment or after treatment completion are additional research scans.

Non-randomized, prospective, single-institution

Prostate MRI and Pylarify PSMA PET/CT

Monitoring Prostate Cancer Tumor Response to Radiation Therapy Using Advanced Functional Magnetic Resonance Imaging (MRI) and Pylarify (18F-DCFPyL) PSMA Positron Emission Tomography (PET)

Difference in the MRI imaging parameter Amide Proton Transfer (APT) weighted relative signal intensity between pretreatment scan and mid-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.

Difference in the MRI imaging parameter Amide Proton Transfer (APT) weighted relative signal intensity between pretreatment scan and end-of-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.

Difference in tumor voxel standard uptake value (SUV) between pretreatment scan and mid-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.

Difference in tumor voxel standard uptake value (SUV) between pretreatment scan and end-of-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer	NCT06074510	Prostate Cancer	Piflufolastat F...	18 Years -	Lantheus Medical Imaging
An Observational Registry Assessing the Impact of PYLARIFY® (Piflufolastat F18) PET in Patients With Prostate Cancer	NCT05712473	Prostate Cancer	PYLARIFY	21 Years -	PPsanalytics
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer	NCT06074510	Prostate Cancer	Piflufolastat F...	18 Years -	Lantheus Medical Imaging
Prostate MRI and Pylarify PSMA PET/CT	NCT05568537	Prostate Cancer	Pylarify Pifluf...	18 Years -	William Beaumont Hospitals

Spots Global Cancer Trial Database for pylarify

Every month we try and update this database with for pylarify cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pylarify

Every month we try and update this database with for pylarify cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pylarify cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.