Study of 177Lu-PSMA-0057 in Metastatic Prostate Cancer

The purpose of this study is to evaluate the effectiveness and safety of 177Lu-PSMA-0057 in metastatic prostate cancer.

This study is a prospective, single arm, open exploratory clinical study. Ten patients with metastatic prostate cancer confirmed by histopathology will be included in the group. Before conducting any research specific screening evaluation, participants must sign an Informed Consent Form (ICF). All screening procedures must be completed within 28 days before the first day of administration (D1). During the screening period, patients will be scanned using 68Ga-PSMA-0057 to determine the PSMA expression status. It is recommended to perform a 68Ga-PSMA-0057 scan after confirming all other qualification requirements. The successfully screened subjects underwent baseline examination 1 day before administration (D-1) (The laboratory examination and ECG are limited to the examination data within 7 days of our hospital, while imaging is limited to the data within 28 days of our hospital), and were confirmed to meet the enrollment requirements before enrollment. The enrolled subjects will be administrated with 177Lu-PSMA-0057, and then enter the post administration observation phase while completing safety checks. After the safety evaluation, the subjects may temporarily leave the research institution. At the end of the second treatment cycle, the improved RECIST version 1.1/PCWG3 criterion was used to rate the tumor remission. Perform CT/MRI and other imaging examinations at the screening period, the end of the second treatment cycle, and at the end of treatment/early termination of the visit (those who have undergone CT/MRI and other imaging examinations within 28 days before the end of treatment/early termination of the visit may be exempted). Perform prostatic specific antigen(PSA) assessment at the end of the second treatment cycle to determine and confirm PSA response. Conduct comprehensive safety checks at baseline, end of treatment visit/early termination visit, including vital signs, physical examination, laboratory examination (including blood routine, blood biochemistry, coagulation function, urine routine), total serum PSA level, serum testosterone measurement, ECG examination, and echocardiography. Safety check after administration: ① ECG examination: Weekly blood routine check after administration in cycles 1 and 2; ② Blood routine examination: After the first and second cycles of administration, weekly blood routine examination is conducted; ③ Blood biochemistry, coagulation function, and urine routine examination: After administration in the first cycle, blood biochemistry, coagulation function, and urine routine examination should be rechecked every week, and once at the end of the second cycle; ④ Echocardiography: Recheck once at the end of the second cycle.