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Label indication PYLARIFY is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. FDA label
Also known as 18F-DCFPyL Injection, PyL, Piflufolastat F 18 Intravenous Solution [PYLARIFY], PYLARIFY, Piflufolastat, Piflufolastat F-18, Fluorine F 18 DCFPyL
18F-DCFPyL · 3 trials · 4 indications
The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
To determine if PSMA-Targeted PET/MRI improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
| Arm | Type | Description |
|---|---|---|
| 18F-DCFPyL Injection | EXPERIMENTAL | 9 mCi (333 MBq) IV injection of 18F-DCFPyL |
| 18F-DCFPyL | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 18F-DCFPyL | DRUG | A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL |
| PET/CT Imaging | DIAGNOSTIC_TEST | PET/CT imaging will be acquired 1-2 hours post-PyL injection |
| 18F-DCFPyL Injection | DRUG | A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL |
Inclusion Criteria: * Male \>/= 18 years of age * Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy * Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of: 1. Post-radical prostatectomy...
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18F-DCFPyL is an imaging agent used in prostate cancer. It is administered before PET/CT or PET/MRI scans to help visualize prostate cancer lesions, including suspected recurrence and metastatic disease. It is being developed by Lantheus Holdings, Inc. as 18F-DCFPyL Injection.
18F-DCFPyL targets PSMA, or prostate-specific membrane antigen, a protein expressed on prostate cancer cells. By binding PSMA, the radiolabeled agent accumulates in prostate cancer tissue and is detected during PET imaging, allowing clinicians to localize and characterize prostate cancer lesions.
18F-DCFPyL is developed by Lantheus Holdings, Inc., which trades on the Nasdaq under the ticker LNTH. The company is advancing the agent as 18F-DCFPyL Injection for prostate cancer imaging.
18F-DCFPyL is in Phase 3 clinical development for prostate cancer. It is an investigational imaging agent and is not approved. Its clinical program includes three trials, of which two are completed and one is active but not recruiting.
18F-DCFPyL has been studied in three trials. NCT03739684 was a Phase 3 study of 18F-DCFPyL PET/CT imaging in suspected recurrent prostate cancer, completed with 208 patients. NCT02981368 was a Phase 2 PET/CT imaging study completed with 385 patients. NCT03392181 is an early Phase 1 PET/MRI staging study that is active but not recruiting.
Yes. 18F-DCFPyL Injection is the same agent as 18F-DCFPyL. The full name is used to describe the formulated product administered to patients before PET imaging in prostate cancer studies.