None listed
Conditions
Interventions
Others : Examination Method:
Administer a dose of [18-F]Florastamin at a dosage of 10 ± 1 mCi intravenously, followed by [18F]Florastamin PET/CT imaging from the head to the thighs 105 ± 15 minutes p
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male patients aged 19 to 80 years Patients diagnosed with histopathologically confirmed prostate cancer Intermediate or high-risk prostate cancer according to the D'Amico classification Adequate functional status to carry out normal daily activities (Eastern Cooperative Oncology Group performance status of 0 or 1) Patients capable of understanding and voluntarily consenting to the contents of the informed consent form
Exclusion criteria
Exclusion criteria: Patients suspected of pelvic distant metastases based on imaging or tissue examination Patients with prior pelvic radiotherapy Patients who have received hormone therapy, neoadjuvant chemotherapy, or radiotherapy for prostate cancer Patients with reported allergies to substances used in previous PET/CT or MRI scans or research Life expectancy of less than 5 years Uncontrolled infectious diseases (persistent sepsis with fever despite treatment) Mental disorders (schizophrenia, bipolar disorder, intellectual disability) Patients with moderate to severe cardiovascular, cerebrovascular, respiratory, or hepatic diseases or other comorbidities that render them unsuitable for clinical trial participation Patients diagnosed with another type of cancer within 2 years (excluding non-metastatic skin basal cell or cutaneous superficial squamous cell carcinoma (T1-3N0M0) or superficial bladder cancer) Patients with pelvic metal implants affecting the quality of PET/CT images Other patients deemed unsuitable for participation in the clinical trial according to investigator discretion Claustrophobia Patients who have undergone Ga-68 PSMA-11 PET-CT before treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate (progression defined as biochemical recurrence, radiographic recurrence, castration-resistant prostate cancer progression, or death) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the progression-free survival rate and diagnostic and clinical evaluations post-prostate cancer treatment between the [F-18] Florastamin PSMA PET/CT group and a prospective cohort-matched control group (SUPER-PC-RP). | — |
Countries
Korea, Republic of
Contacts
Public ContactJang Hee Han
Seoul National University Hospital
Outcome results
None listed