Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DCFPyl Ligand · 1 trial · 1 indication
Compare \[18F\]DCFPyL PET imaging combined with whole body magnetic resonance imaging (MRI) and multiparametric pelvic/prostate MRI to conventional imaging modalities (CIM)--such as 99mTc-methylene diphosphonate bone scan (BS) and contrast-enhanced CT (CECT) of the abdomen and pelvis, or a newly approved PET imaging agent F-18 Fluciclovine, for the localization and determination of extent of recurrent/metastatic disease in patients with biochemical recurrence of prostate cancer or evidence of recurrence on CIM.
Determine the sensitivity and specificity of \[18F\]-DCFPyL PET/MRI for extent of recurrent/metastatic disease in patients with biochemical recurrence.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [18F]-DCFPyl Ligand | DRUG | To assess the performance of \[18F\]-DCFPyl PET with whole-body MRI and multiparametric pelvic/prostate MRI for PCa detection in men with recurrence as determined by biochemical PSA level or evidence on CIM. Results of tracer uptake and MRI image features on whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on CIM that usually includes bone scan (BS) and CT scan of the abdomen and pelvis, or PET imaging with F-18 Fluciclovine.In addition, in patients who undergo biopsy when performed as standard of care, we will correlate image features directly with histopathological findings on lesion biopsy to directly demonstrate that 'radiotracer and/or MRI positive' lesions contain tumor cells. |
Inclusion Criteria: * subject has prostate cancer treated with surgery, radiation therapy and/or chemotherapy for localized disease * subject has biochemical recurrence defined in postsurgical patients as a PSA value = \> 0.2 ng/mL followed by a subsequent confirmatory PSA value = \>0.2 ng/mL accor...
Top 20 of 53 competitors
DCFPyl Ligand is an investigational small molecule being studied for use in prostate cancer. It is a radiofluorinated PSMA ligand intended for molecular imaging of prostate cancer. The drug is currently in early Phase 1 clinical development and is not yet approved by the FDA.
DCFPyl Ligand targets prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. As a radiofluorinated PSMA ligand, it is designed to bind to PSMA for molecular imaging purposes, potentially enabling visualization of prostate cancer lesions.
DCFPyl Ligand is being developed by Lantheus Holdings, Inc., a company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting clinical research on this investigational imaging agent for prostate cancer.
DCFPyl Ligand is in early Phase 1 clinical development. A single early Phase 1 trial has been completed, involving 20 participants with prostate cancer. The drug remains investigational and has not received FDA approval.
DCFPyl Ligand has one completed clinical trial, NCT04266392, titled 'Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand.' This early Phase 1 study enrolled 20 participants with prostate cancer in the United States and was an uncontrolled, non-randomized trial.