NCT07115277

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (estimated)
• Sponsor: Sinotau Pharmaceutical Group · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Flotufolastat F-18 Injection	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.

Timeline

• Start date: 2025-03-14
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-08-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: China