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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
121
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.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGTo evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with biochemical recurrence (BCR)
Correct Detection Rate (CDR) at the individual level of Flotufolastat F-18 Injection PET imaging in prostate cancer subjects with BCR
Time frame: 90 days
To evaluate other diagnostic performance parameters of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with BCR
Positive predictive value (PPV) of Flotufolastat F-18 Injection PET imaging at the individual level in prostate cancer subjects with BCR. PPV and CDR of Flotufolastat F-18 Injection PET imaging in the prostate bed, pelvic lymph nodes, and three other regions in Chinese prostate cancer subjects with BCR.
Time frame: 90 days
To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in different subgroups of Chinese prostate cancer subjects with BCR
Individual-level PPV and CDR of Flotufolastat F-18 Injection PET imaging in subjects whose baseline conventional imaging is negative. Individual-level PPV and CDR of Flotufolastat F-18 Injection PET imaging at different PSA levels.
Time frame: 90 days
To evaluate inter-reader and intra-reader interpretative consistency among independent blinded readers.
Kappa values for inter-reader and intra-reader agreement in the interpretation of the same Flotufolastat F-18 Injection PET imaging by different independent blinded readers and by the same reader at different times.
Time frame: 90 days
To evaluate the safety of Flotufolastat F-18 Injection .
The types, severity, frequency, and outcomes of adverse events/serious adverse events reported during the study period.
Time frame: 3 days
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