Safety and Preliminary Diagnostic Performance of [⁶⁴Cu]Cu-RAX301 in Prostate Cancer

Exclusion criteria

• . Known or suspected hypersensitivity to the active component(s) of \[⁶⁴Cu\]Cu-RAX301 Injection or any of its excipients.
• . Inability to complete \[⁶⁴Cu\]Cu-RAX301 Injection PET/CT imaging as required by the protocol.
• . Participation in another interventional clinical trial prior to signing the informed consent form, within 5 half-lives of the investigational product, or current participation in another interventional clinical trial; or prior participation in a radiopharmaceutical clinical trial with a washout period of less than 3 months prior to signing informed consent.
• . Receipt of any intravenous iodinated contrast agent within 24 hours prior to administration of the investigational product, or receipt of any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to dosing. Oral water-soluble contrast agents (e.g., compound diatrizoate meglumine oral solution) are permitted.
• . Prior treatment with androgen deprivation therapy (ADT) or any other neoadjuvant therapy.
• . Receipt of high-energy gamma radiation (\>300 keV) prior to dosing, within 5 half-lives of the investigational product.
• . QTcF interval ≥470 msec on 12-lead ECG (corrected using Fridericia's formula).
• . Any medical condition that, in the investigator's judgment, may compromise participant safety, protocol compliance, or interpretation of study results.