Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

Inclusion Criteria12

• Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
• Male ≥ 18 years of age.
• Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
• Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:
• At least 6 weeks after radical prostatectomy (RP): PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL.; or
• Post-radiation therapy, after radical radiotherapy (or cryoablation therapy): Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir .
• Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;
• ECOG score 0 or 2.
• Subjects who meet the following conditions in hematology, renal function, and liver function:
• Platelet count\>50 \* 10\^9/L Urea/urea nitrogen and creatinine\<1.5 times upper limits of normal AST and ALT\<2.5 times upper limits of normal.
• Expected survival time ≥ 6 months.
• Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.