drugset / Trial / NCT07115277

Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer

NCT07115277 ↗

Recruiting 121 enrolled Sinotau Pharmaceutical Group
NaSingle-groupOpen-labelDiagnostic

Summary

The goal of this clinical trial is to evaluate the diagnostic performance and safety of Flotufolastat F-18 injection PET imaging in prostate cancer subjects with biochemical recurrence following prior treatment. The main question it aims to answer is: • What is the correct detection rate of Flotufolastat F 18 injection PET visual reading results compared to the truth standard? Participants will: * Receive Flotufolastat F-18 injection * Undergo PET/CT scanning

Timeline

Start
2025-03-14
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Flotufolastat F-18 Injection Diagnostic / imaging agent 296 mbq Intravenous

Indications