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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
267
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.
Sun Yat-sen University Cancer Center
Guangzhou, China
RECRUITINGSpecificity
The specificity of 18F-Florastamin PET/CT in patients with negative pelvic lymph node metastasis compared with the histopathology. The subjects underwent RP (radical prostatectomy) with PLND (pelvic lymph node dissection) within 28 days after the administration of 18F-Florastamin Injection. The histopathology results of the pelvic lymph node tissue collected from the subjects will be used as the standard of truth for this study.
Time frame: Within 28 days following 18F-Florastamin PET/CT
Sensitivity
The sensitivity of 18F-Florastamin PET/CT in patients with positive pelvic lymph node metastasis compared with the histopathology.
Time frame: Within 28 days following 18F-Florastamin PET/CT
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