prostate cancer
Conditions
Interventions
Gold Standard:pathology
Index test:[68Ga]Ga-GS24-B2-250-T[68Ga]Ga-GS24-B2-268-T[68Ga]Ga-GS24-B2-237-T [68Ga]Ga-PSMA-11 PET/CT imaging
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects are fully informed about the trial content, process, and potential risks, and voluntarily sign the informed consent form; 2. Male subjects aged 18 years or older; 3. Clinically or radiologically assessed as having metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC); 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 5. 68Ga-PSMA-11 PET/CT scan shows positive lesions; 6. Blood routine, renal function, and liver function tests meet the following criteria: (1) Platelet count >90×10^9/L; (2) Urea/urea nitrogen and serum creatinine <1.5 times the upper limit of normal (ULN); (3) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 times ULN; 7. Expected survival time =6 months; 8. From the date of signing the informed consent to 3 months after drug administration, the subject and their partner must use effective contraception, and the subject must avoid sperm donation.
Exclusion criteria
Exclusion criteria: 1. Participated in other interventional clinical trials before signing the informed consent and within 5 half-lives of the trial drug in that study, or currently participating in other interventional clinical trials, or participated in a clinical trial involving radiopharmaceuticals before signing the informed consent and less than 3 months have passed since discontinuation of the drug on the date of signing the informed consent; 2. Received any intravenous iodinated contrast agent within 24 hours before administration, or received any high-density oral contrast agent (such as barium sulfate) within 5 days before administration (oral water-soluble contrast agents, such as compound meglumine ioxitalamate oral solution, are acceptable); 3. Received high-energy ?-rays (>300 KeV, e.g., drugs labeled with radionuclides such as [131I]I, [18F]F, [68Ga]Ga, [64Cu]Cu) before administration and within 5 half-lives or 2 days (whichever is longer) of such exposure; 4. Plan to adjust anti-tumor drug treatment during the study period; 5. Subjects unable to complete PET/CT imaging as required; 6. Any medical condition or other situations judged by the investigator to potentially affect safety or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| standard uptake value, SUV;Tumor-to-Non-tumor Uptake Ratio;rate of lesion detection;number of detected lesion ; laboratory tests;electrocardiogram ;physical examination ; | — |
Secondary
| Measure | Time frame |
|---|---|
| absorbed dose;residence time;vital signs; | — |
Countries
China
Contacts
Public ContactShi Hongcheng
Department of nuclear medicine, Zhongshan Hospital, Fudan University
Outcome results
None listed