A Clinical Study of [68Ga]Ga-ELI421 Injection PET Imaging in Patients With Prostate Cancer

Inclusion criteria

• Has been fully informed about the study and voluntarily provided written informed consent prior to initiation of any study-related procedures;
• Aged ≥ 18 years;
• In generally good condition with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Patients with histopathologically and/or cytologically confirmed prostate cancer;
• Has an indication for PSMA PET imaging;
• No clinically significant abnormal findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or other examinations that may compromise subject safety or imaging results.
• Subjects of reproductive potential agree to refrain from pregnancy, sperm donation, and voluntarily use highly effective contraceptive methods (including by their partner) for 6 months after study drug administration, such as condoms, oral or injectable contraceptives, intrauterine devices (IUDs), etc.

Exclusion criteria

• Presence of comorbidities that may compromise subject safety or interfere with imaging results;
• Concomitant medications that may compromise subject safety or interfere with imaging results;
• Insufficient washout period following prior anti-tumor therapies (including cytotoxic chemotherapy, immunotherapy, radiotherapy, etc.), which may compromise subject safety or interfere with imaging results;
• Known hypersensitivity to ionizing radiation or alcohol, or hypersensitivity to [⁶⁸Ga]Ga-ELI421 injection or its excipients, or other history of severe allergic reactions;
• Inability to complete PET imaging as required;
• Any other conditions deemed inappropriate by the investigator for participation in this study.