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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03495427 | PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores | PHASE2 | RECRUITING | 60 | — | — | Dec 18, 2019 | May 1, 2029 | Mar 2, 2026 | 1 | United States |
To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
| Arm | Type | Description |
|---|---|---|
| Radioactive Diagnostic Imaging | EXPERIMENTAL | Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access. |
| Name | Type | Description |
|---|---|---|
| F-DCFPyL Injection | DRUG | F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer. |
| PSMA PET | DIAGNOSTIC_TEST | PSMA PET imaging (for men with high GC \>0.45) will be done after 2 years post-treatment, then yearly up to 5 years. |
Inclusion Criteria: * This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (...