At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging in Patients With Prostate Cancer With Rising PSA Levels [Biochemical Recurrence (BCR)]
In Brief
A Phase 3 clinical trial evaluating [18F]CTT1057 and [68Ga]Ga-PSMA-11 for Prostatic Neoplasms and 2 related conditions. Completed, enrolled 190 participants across 13 sites in 4 countries.
Detailed Summary
The current study aimed at evaluating the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of Prostate specific membrane antigen (PSMA) positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard. Approximately 190 participants were to be enrolled to ensure at least 152 participants were evaluable (i.e. have both an evaluable \[18F\]CTT1057 Positron emission tomography/Computed Tomography (PET/CT) scan imaging and at least one evaluable Composite Truth Standard (CTS) assessment and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures, which were required for the calculation of the co-primary endpoints.
Study Details
Timeline
Interventions
Single intravenous dose of approximately 370 Mega-Becquerel (MBq) and subsequent PET/CT scan
Single intravenous dose of approximately 150 MBq and subsequent PET/CT scan