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COMPLETED
NCT06011304
PHASE3

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

Sponsor: HTA Co., Ltd.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

287

Start Date

2023-10-20

Completion Date

2026-04-16

Last Updated

2026-09-29

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, China