At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 195 enrolled
Drug / intervention
[18F]CTT1057drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth
In Brief
A Phase 3 clinical trial evaluating [18F]CTT1057 for Prostatic Neoplasms and Prostate Cancer. Completed, enrolled 195 participants across 16 sites in 5 countries.
Detailed Summary
The purpose of this study was to evaluate the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) were used for the histopathology assessments.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms, Prostate Cancer
CountriesFrance, Italy, Spain, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartSep 2021
Primary CompletionNov 2023
TodayJul 2026
First PostedApr 9, 2021
Enrollment StartSep 7, 2021
Primary CompletionNov 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.2 years ago
Interventions
[18F]CTT1057drug
PET/CT imaging with \[18F\]CTT1057