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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
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 studied as a PET/CT and PET/MRI imaging agent in men with suspected recurrence of prostate cancer, in staging of newly diagnosed prostate cancer, and in patients with prostate cancer generally. It is a small molecule developed by Lantheus Holdings, Inc.
18F-DCFPyL targets PSMA, or prostate-specific membrane antigen. PSMA is a protein expressed on prostate cancer cells, and binding to it allows the agent to be detected during PET imaging. This makes 18F-DCFPyL a PSMA-targeted small molecule imaging agent for prostate cancer.
18F-DCFPyL is developed by Lantheus Holdings, Inc., which trades on the Nasdaq under the ticker LNTH. The company is the sponsor of the clinical trials studying the agent in prostate cancer imaging.
18F-DCFPyL is in Phase 3 clinical development and is investigational. Its trial program includes a completed Phase 3 study, a completed Phase 2 study, and an early Phase 1 study that is active but not recruiting. It has not been established as approved.
18F-DCFPyL has been studied in three trials. NCT03739684 was a completed Phase 3 study of PET/CT imaging in suspected recurrent prostate cancer with 208 patients. NCT02981368 was a completed Phase 2 study in prostate cancer with 385 patients. NCT03392181 is an active early Phase 1 PET/MRI staging study with 48 patients.
Yes. 18F-DCFPyL Injection is an alternative name for 18F-DCFPyL. Both names refer to the same PSMA-targeted small molecule imaging agent developed by Lantheus Holdings, Inc. for use in prostate cancer PET imaging.