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
Radical prostatectomy (RP);
RP with adjuvant radiotherapy (RT);
RP with adjuvant androgen deprivation therapy (ADT);
Radical RT or focal gland therapy (e.g., brachytherapy, high-intensity focused ultrasound [HIFU]).
Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.
Participation in an interventional clinical trial involving a new drug or treatment within 30 days or 5 biological half-lives of the drug prior to XTR020 PET imaging (whichever is longer).
Known allergy to the active ingredient or any excipient of XTR020.
Claustrophobia or inability to tolerate imaging examinations for any other reason.
Single group
Flotufolastat F-18 Injection
DrugAll 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.
To 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
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.
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.
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.
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.
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