NCT06011304

Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer

A Phase III, Open-Label, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 267 (estimated)
• Sponsor: HTA Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging. This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	[18F]Florastamin Injection	The subjects who participate in phase 3 study will be intravenously injected with \[18F\]Florastamin Injection and undergo PET/CT scan at 110 min after the injection. Subjects who participate in pilot study will be intravenously injected with \[18F\]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection.

Timeline

• Start date: 2023-10-20
• Primary completion: 2024-11-01
• Completion: 2025-01-01
• First posted: 2023-08-25
• Last updated: 2023-10-23

Locations

1 site across 1 country: China