Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 investigational small molecule being developed for prostate cancer imaging. It is a positron emission tomography (PET) radiotracer used to detect prostate cancer lesions, including suspected recurrence and metastatic disease. It is currently in Phase 3 clinical development and is not yet approved by the FDA.
18F-DCFPyL is being developed by Lantheus Holdings, Inc. (NASDAQ: LNTH). The company is conducting clinical trials to evaluate the imaging agent in patients with prostate cancer.
18F-DCFPyL is in Phase 3 clinical development for prostate cancer. It has completed a Phase 3 trial (NCT03739684) and a Phase 2 trial (NCT02981368), with an additional early Phase 1 trial (NCT03392181) that is active but not recruiting.
18F-DCFPyL has been studied in three clinical trials. NCT02981368 was a completed Phase 2 study in 385 patients with prostate cancer. NCT03392181 is an active early Phase 1 PET/MRI staging study in 48 patients. NCT03739684 was a completed Phase 3 study in 208 patients with suspected recurrence.
18F-DCFPyL is a small molecule PET imaging agent that binds to prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. After injection, it accumulates in PSMA-positive tumors, allowing PET/CT or PET/MRI imaging to visualize cancer lesions.
18F-DCFPyL is not FDA approved. It is an investigational agent currently in Phase 3 clinical development for prostate cancer imaging. The completed Phase 3 trial evaluated its use in patients with suspected recurrence of prostate cancer.