Piflufolastat F 18

Generic Name: Piflufolastat F 18

Brand Names: Pylarify, Pylclari

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₃FN_₄O_₈

CAS Number: 1207181-29-0

Unique Ingredient Identifier: 3934EF02T7

Background: Prostate cancer is the most common non-cutaneous malignancy affecting men in North America - despite this, an ongoing challenge in prostate cancer therapy is the difficulty in imaging the extent and location of tumor metastases and recurrences. The images generated by positron emission tomography (PET) are less detailed than those obtained via MRI or CT, but...

Indication: Piflufolastat F18 is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer who have suspected metastases and are candidates for initial definitive therapy and for men with a suspected recurrence of prostate cancer based on elevated prostate-specific antigen (PSA) levels by t...

Associated Conditions: Prostate Cancer, Recurrent Prostate Cancer

Associated Therapies: -

Clinical Trials

18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer

Phase 2

Conditions: Prostate Cancer

Interventions: Drug: 18F-DCFPyL

First Posted Date: 2020-05-18

Last Posted Date: 2021-04-08

Lead Sponsor: VA Greater Los Angeles Healthcare System

Target Recruit Count: 400

Registration Number: NCT04390880

Locations: 🇺🇸
VA Greater Los Angeles Healthcare System, Los Angeles, California, United States

Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: 18F-DCFPyL

First Posted Date: 2019-06-06

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 175

Registration Number: NCT03976843

Locations: 🇺🇸
Tulane University, New Orleans, Louisiana, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

and more 3 locations

Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Castrate Sensitive Prostate Cancer

Interventions: Drug: goserelin
Drug: Enzalutamide
Drug: Abiraterone
Drug: 18F-DCFPyL
Drug: Prednisone
Procedure: Radical Prostatectomy

First Posted Date: 2019-03-04

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 11

Registration Number: NCT03860987

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Image-guided Focal Brachytherapy Utilizing Combined 18F-DCFPyl PET/CT

Early Phase 1

Recruiting

Conditions: Prostate Cancer

Interventions: Radiation: Focal brachytherapy with PSMA PET imaging
Drug: (18F)DCFPyL

First Posted Date: 2019-03-04

Last Posted Date: 2023-12-26

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 20

Registration Number: NCT03861676

Locations: 🇺🇸
SKCCC at Johns Hopkins, Baltimore, Maryland, United States

18F-DCFPyL PET-CT Scan and Prostate Cancer

Phase 2

Conditions: Prostate Cancer Adenocarcinoma

Interventions: Drug: 18F-DCFPyL

First Posted Date: 2019-02-25

Last Posted Date: 2019-02-25

Lead Sponsor: Lida Jafari

Target Recruit Count: 170

Registration Number: NCT03852654

Locations: 🇺🇸
VA Greater Los Angeles, Los Angeles, California, United States

Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

Phase 3

Completed

Conditions: Prostate Cancer Metastatic
Prostate Cancer Recurrent
Prostate Cancer
Prostate Adenocarcinoma

Interventions: Drug: 18F-DCFPyL
Diagnostic Test: PET/CT Imaging

First Posted Date: 2018-11-14

Last Posted Date: 2021-06-14

Lead Sponsor: Progenics Pharmaceuticals, Inc.

Target Recruit Count: 208

Registration Number: NCT03739684

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸
University of California San Francisco - Helen Diller Cancer Center, San Francisco, California, United States

and more 11 locations

PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Early Phase 1

Conditions: Prostate Cancer

Interventions: Drug: 18F-DCFPyL

First Posted Date: 2018-01-05

Last Posted Date: 2020-02-27

Lead Sponsor: Northwestern University

Target Recruit Count: 48

Registration Number: NCT03392181

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy

Phase 1

Active, not recruiting

Conditions: Prostate Cancer
Prostatic Neoplasm

Interventions: Drug: 18F-DCFPyL
Radiation: Tumor Irradiation
Radiation: Prostate + tumor irradiation

First Posted Date: 2017-08-18

Last Posted Date: 2024-11-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT03253744

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer

Phase 2

Conditions: Prostatic Cancer
Prostate Cancer
Prostate Neoplasms
Cancer Of Prostate
Metastatic Prostate Cancer

Interventions: Drug: 18F-DCFPyL
Drug: PSMA-11
Drug: 18F-FDG

First Posted Date: 2017-06-09

Last Posted Date: 2024-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 330

Registration Number: NCT03181867

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Prostate Cancer
Prostatic Cancer
Prostate Neoplasms
Prostatic Neoplasms
Prostate Cancer

Interventions: Drug: 18F-NaF
Drug: 18F-DCFPyL
Drug: 18F-FDG

First Posted Date: 2017-06-02

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 96

Registration Number: NCT03173924

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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