Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer
A Single-arm, Multicenter, Phase III Clinical Trial , Evaluate the Diagnostic Performance and Safety of Flotufolastat F-18 Injection PET Imaging in Prostate Cancer Subjects With Biochemical Recurrence Following Prior Treatment
Sinotau Pharmaceutical Group
121 participants
Mar 14, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
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Interventions
All patients will receive one injection of Flotufolastat F-18 Injection, a PET radiopharmaceutical selective for PSMA. For the injection, subjects will receive a target dose of 8 mCi (296 MBq) ± 20% IV as a bolus injection. Flotufolastat F-18 Injection will be followed by a 10 ml saline flush.
Locations(1)
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NCT07115277