A Phase I Study to Assess the Safety, Tolerability, Radiation Dosimetry and Efficacy of [177Lu] Lu-PSMA-XT in Patients With Metastatic Prostate Cancer
This was a multicenter, open-label, phase I study to evaluate the safety, tolerability, radiation dosimetry and efficacy of \[177Lu\] Lu-PSMA-XT injection in patients with metastatic prostate cancer .
• Patients must have the ability to understand and sign an approved informed consent form (ICF).
• Patients must be \>= 18 and \<＝80 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must have a life expectancy \>6 months.
• Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
• Patients must be PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive。
• Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
• Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.
• Patients must have progressive mCRPC.
⁃ Patients must have adequate organ function。
⁃ Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.