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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03762759 | Fluciclovine F18 or Ga68-PSMA PET/CT to Enhance Prostate Cancer Outcomes | PHASE2 | ACTIVE NOT_RECRUITING | 140 | — | — | May 10, 2019 | Dec 31, 2025 | May 17, 2024 | 3 | United States |
A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.
| Arm | Type | Description |
|---|---|---|
| Arm I (fluciclovine F18, PET/CT) | EXPERIMENTAL | Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. |
| Arm II (68Ga-PSMA, PET/CT) | ACTIVE_COMPARATOR | Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes. |
| Name | Type | Description |
|---|---|---|
| Computed Tomography | PROCEDURE | Undergo PET/CT |
| Fluciclovine F18 | DRUG | Given IV |
| Gallium Ga68-labeled PSMA-11 | RADIATION | Given IV |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
Inclusion Criteria: * Adenocarcinoma of the prostate, post radical-prostatectomy * Detectable prostate-specific antigen (PSA) * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2 * No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) o...