Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTT1057 · 2 trials · 3 indications
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 ...
CTT1057 is an investigational small molecule being studied for use in prostatic neoplasms, specifically prostate cancer. It is a diagnostic imaging agent, as it is being evaluated in clinical trials for its diagnostic performance in detecting prostate cancer recurrence and PSMA-positive tumors. It is not approved and remains in clinical development.
CTT1057 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the diagnostic performance of this investigational imaging agent in prostate cancer patients.
CTT1057 is in Phase 3 clinical development. One completed Phase 3 trial evaluated its diagnostic performance in biochemical recurrence of prostate cancer, and a completed Phase 2 trial assessed its ability to detect PSMA-positive tumors. It remains investigational and is not FDA approved.
CTT1057 has been studied in two completed clinical trials. NCT04838613 was a Phase 3 study of its diagnostic performance in biochemical recurrence of prostate cancer with 190 participants. NCT04838626 was a Phase 2 study for PSMA-positive tumor detection with 195 participants. Both enrolled adult males.
CTT1057 is a small molecule diagnostic imaging agent that targets prostate-specific membrane antigen, or PSMA, which is overexpressed on prostate cancer cells. By binding to PSMA, it enables detection of prostate cancer lesions through imaging. It is being studied for its diagnostic performance in prostate cancer.