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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04838613 | Study of Diagnostic Performance of [18F]CTT1057 in BCR | PHASE3 | COMPLETED | 190 | — | — | Sep 30, 2021 | Nov 23, 2023 | Oct 20, 2025 | 13 | United States, France +2 |
| NCT04838626 | Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection | PHASE2 | COMPLETED | 195 | — | — | Sep 7, 2021 | Nov 24, 2023 | Oct 7, 2025 | 16 | United States, France +3 |
Region-level correct localization rate (CLR) is defined as the percentage of regions containing at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding.
Patient-level positive predictive value (PPV) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are PET/CT scan positive.
Sensitivity of vidoflufolastat (18F) Positron Emission Tomography (PET) imaging, considering Prostate Specific Membrane Antigen (PSMA) positive patients as those who show at least one pathological vidoflufolastat (18F) uptake either in the primary tumor and/or metastatic Pelvic Lymph Node (PLN) regions, with anatomically localized correspondence with the Standard of Truth (SoT).
Specificity of vidoflufolastat (18F) PET imaging, defined as proportion of PLN regions that test negative for lymph nodes on vidoflufolastat (18F) among those that are lymph node negative on the SoT.
| Arm | Type | Description |
|---|---|---|
| PET/CT imaging with [18F]CTT1057 followed by [68Ga]Ga-PSMA-11 or vice versa | EXPERIMENTAL | All eligible participants were assigned to one of the following two PET/CT scan sequences at random in a 1:1 ratio: * Sequence 1: \[18F\]CTT1057 on Day 1 (investigational imaging agent of interest) followed by \[68Ga\]Ga-PSMA-11 at least 14 days apart (as part of CTS if required, and for secondary endpoint) * Sequence 2: \[68Ga\]Ga-PSMA-11 (as part of CTS if required, and for secondary endpoint) on Day 1 followed by \[18F\]CTT1057 (investigational imaging agent of interest) at least 14 days apart |
| PET/CT imaging with [18F]CTT1057 | EXPERIMENTAL | All eligible participants will be enrolled to receive \[18F\]CTT1057 imaging agent on Day 1 and have PET/CT scan |
| Name | Type | Description |
|---|---|---|
| [18F]CTT1057 | DRUG | Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan |
| [68Ga]Ga-PSMA-11 | DRUG | Single intravenous dose of approximately 150 MBq and subsequent PET/CT scan |
Inclusion Criteria * Signed informed consent must be obtained prior to participation in the study * Biopsy proven prostate adenocarcinoma. * Biochemical recurrence following initial definitive therapy (with either RP or curative intent radiation therapy) as defined: by AUA criteria (Cookson et al ...