Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04266392 | Molecular Imaging of Prostate Cancer Using Radiofluorinated PSMA Ligand | EARLY_PHASE1 | COMPLETED | 20 | — | — | Dec 16, 2019 | Oct 15, 2021 | May 5, 2022 | 1 | United States |
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...