None listed
Conditions
Interventions
Drug : 1) General name of main ingredient: [F-18]Florastamin
2) Appearance: Injection
3) Usage·Dosage and Administration Method: [F-18]Florastamin is administered at a dose of 370 ± 37 MBq (10 ±1 mCi
Sponsors
FutureChem
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Prostate cancer patient group 1. Prostate cancer patient diagnosed histologically - Patient diagnosed with prostate cancer by planning surgery and performing biopsy - Patients with elevated PSA after prostatectomy or radiation therapy - Patients found with clinical progression of prostate cancer 2. Subjects who have been fully informed of the purpose and contents of the trial and characteristics of the investigational product before enrolling in the clinical trial by subinvestigators and signed the consent form by themselves, their guardian or a legal representative. 3. Male patient aged 19 or older 4. ECOG _ Performance scale =2 5. Expect at least 12 months of survival 6. Those who meet the following conditions in blood tests, renal and liver function tests - Platelet count (PLT)> 50,000/µL - BUN and serum creatinine <1.5 x upper limit of normal (ULN) - AST and ALT <2.5 x upper limit of normal (ULN) - Left ventricle ejection fraction > 60% if there is a history of heart disease
Exclusion criteria
Exclusion criteria: 1. Those who were judged as difficult to conduct the clinical trial due to serious medical conditions by the investigator 2. Those who were judged to have a mental illness that makes it difficult to obtain positron emission tomography (PET) by the investigator 3. Participant in another clinical trial that may affect [F-18]Florastamin PET image acquisition from enrolling in the clinical trial to the end of the clinical trial or may affect the safety assessment following intravenous injection of [F-18]Florastamin (e.g., a subject from a cohort clinical trial that is conducted with only a follow-up observation without receiving the investigational product from enrollment until the end of the clinical trial can participate.) 4. Those who were judged as inappropriate to participate in the clinical trial by the investigator 5. Vulnerable subjects (investigator self or one’s family who participated in the trial, investigator or students of investigator who participated in the study, or families of the subjects)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of [F-18]Florastamin in Patients with Prostate Cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoint: Physical examination, vital signs, EKG, chest x-ray, laboratory tests (biochemistry, hematology, urinalysis), adverse events assessed by NCI-CTCAE ver 5.0, systemically absorbed dose | — |
Countries
Korea, Republic of
Contacts
Public ContactHyo Jung Park
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed