[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer

Prior treatment

• Subjects who have the following disease within 6 months prior to screening:
  • Heart failure that falls into Class III or IV heart failure classified by New York Heart Association;
  • Embolism pulmonary, acute coronary syndrome (unstable angina or myocardial infarction);
  • Acute severe respiratory syndrome;
  • Cerebrovascular disease such as stroke;
  • Uncontrollable hypertension (SBP \> 160 mmHg or DBP \> 90 mmHg);
  • Uncontrollable heart arrhythmia;
  • Blood clotting disorder.
• Patients who are receiving radiation therapy or ablative therapy on the prostate bed within 12 weeks prior to screening
• Patients whose method of systemic treatment for prostate cancer (e.g., hormone therapy, biological therapy, radiation therapy, or chemotherapy) has changed within 3 months prior to screening, or who have to change orstart systemic treatment for prostate cancer while the study is being conducted (until before a biopsy or PLND) However, when systemic treatment has changed into watchful waiting, the patient can participate in the study.
• Subjects with solid tumors other than prostate cancer or hematologic malignancies including lymphoma within 3 years prior to screening (however, they can be enrolled in the case of properly treated non-melanoma skin cancer)
• Subjects who received gamma-emitting radioactive isotopes of high energy (\> 300 keV) within the period 5 times longer than the half-life of this investigational product (about 10 hours) prior to screening

Other illness

• Subjects who are suffering from active infectious disease at screening and determined unfit to participate in this study;
• Subjects with hypersensitivity to radioisotopes
• Subjects who cannot undergo necessary imaging examinations due to medical conditions or other conditions (serious claustrophobia, radiophobia, etc.) that undermine the subject safety or compliance status for generating reliable data or completing the study in the principal investigator's judgment

Lab values

• According to the laboratory test results, patients who meet the following criteria:
  • Platelet counts (PLT) \< 50,000/μL;
  • Serum creatinine \> 1.8 mg/dL or eGFR (or GFR) \< 30 mL/min/1.7 m2;
  • AST and ALT \> 2.5 x upper limit of normal (ULN) (however, for a patient whose hepatic metastasis has been confirmed, AST and ALT \> 5 x ULN).

Other

• Subjects who participate in other clinical studies that may affect image obtainment from \[18F\]Florastamin-PET/CT or safety evaluation following IV injection of \[18F\]Florastamin from the time of enrollment for this study until the end (however, they can be enrolled if participating in a cohort clinical study conducted mainly through simple follow-up without administration of IP from the time of enrollment for the study until the end)

• Male aged 19 and older
• Patients histopathologically diagnosed with prostate cancer
• Patients who can undergo a percutaneous biopsy or PLND for more than one lesion locations with locally recurrent, new or advanced metastasis as confirmed by MRI or whole-body bone scan performed within 6 weeks prior to screening
• Patients whose survival is expected to be at least 6 months with ECOG Performance Status ≤ 2
• Those whose ICF was signed by themselves or their legal guardian or representative after sufficient explanation was given by the investigator about the study objectives, details, characteristics of the investigational device, etc. before enrolled for the study.