Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer

Prior treatment

• 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).

Other illness

• Known allergy to the active ingredient or any excipient of XTR020.
• Any condition that, in the opinion of the investigator, may interfere with data collection or prevent the study requirements.

Other

• Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.
• Claustrophobia or inability to tolerate imaging examinations for any other reason.
• Poor compliance or deemed unsuitable for participation in this study by the investigator.

• 1\. Fully understand the study and voluntarily sign the informed consent form. 2. Male, aged ≥18 years. 3. Has previously received one or more of the following treatments:
• 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 \[HIFU\]).
  • 4\. Clinically suspected BCR, serum PSA levels should meet at least one of the followings:
  • After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng/mL, and subsequent confirmation that PSA ≥ 0.2 ng/mL.
  • After RT as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
  • After focal gland therapy as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
  • 5\. If positive lesions are detected on the XTR020 PET imaging or conventional imaging, the subject is willing to receive histopathological confirmation or the sequqnce of conventional imaging confirmation.
  • 6\. Male subjects with reproductive potential must use effective contraception during the study period and 6 months after the study completed; their partners should agree to use contraception during the study period and 6 months after the study completed , too.