The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC
have the ability to understand and sign an approved informed consent form (ICF).
>= 18 years old.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
have a life expectancy >6 months.
Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.
Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
Known hypersensitivity to the components of the study therapy or its analogs.
A superscan as seen in the baseline bone scan.
Sequential
225Ac-PSMA-XT
DrugPatients will receive 225Ac-PSMA-XT administration at an interval of 6 weeks between each dose.
Treatment emergent adverse events
To evaluate the safety and tolerability of \[177Lu\]Lu-PSMA-XT Injection assessed from the number and incidence of patients with adverse events using CTCAE v5.0 and physical examination, electrocardiogram and laboratory abnormality, etc.
Dose-limiting toxicity（DLT）
Incidence and severity of dose-limiting toxicities.
Prostate-specific Antigen 50 (PSA50) Response
PSA50 response was defined as the proportion of participants who had a \>= 50% decrease in PSA from baseline confirmed by a PSA measurement \>= 4 weeks later.
Radiographic Progression-free Survival (rPFS)
Radiographic progression-free survival (rPFS) was defined as the time (in months) from the date of enrollment to the date of radiographic disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death due to any cause.
Overall Response Rate (ORR)
Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR was based on RECIST 1.1 response for patients with measurable disease at baseline.
Duration of Response (DOR)
Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause .
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Xiaorong Sun
Lead sponsor
Shandong Cancer Hospital and Institute
Sponsor institution
