Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 18F-DCFPyL Injection
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 to help visualize prostate cancer lesions during PET/CT or PET/MRI scans. It is studied in patients with suspected recurrence of prostate cancer and in staging of newly diagnosed disease. It is a small molecule that binds PSMA, a protein expressed on prostate cancer cells.
18F-DCFPyL targets PSMA, or prostate-specific membrane antigen, a protein expressed on the surface of prostate cancer cells. By binding PSMA, the agent concentrates in prostate cancer tissue and allows PET imaging to detect and localize lesions. This PSMA-targeted approach is the basis for its use as a diagnostic imaging agent.
18F-DCFPyL is developed by Lantheus Holdings, Inc., which trades under the ticker LNTH. The company is responsible for the clinical development of the agent in prostate cancer imaging.
18F-DCFPyL is in Phase 3 clinical development. It is an investigational imaging agent and is not described as approved. Its clinical program includes completed Phase 2 and Phase 3 trials as well as an active early Phase 1 study.
18F-DCFPyL has been studied in three clinical trials. NCT03739684 was a completed Phase 3 study of PET/CT imaging in patients with suspected recurrence of prostate cancer. NCT02981368 was a completed Phase 2 imaging study, and NCT03392181 is an active early Phase 1 PET/MRI staging study in newly diagnosed prostate cancer.
Yes, 18F-DCFPyL Injection is another name for 18F-DCFPyL. Both refer to the same PSMA-targeted imaging agent developed by Lantheus Holdings, Inc. for use in prostate cancer PET imaging.