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The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 225Ac-PSMA-XT treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 225Ac-PSMA-XT | Drug | Patients will receive 225Ac-PSMA-XT administration at an interval of 6 weeks between each dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, assessed up to 2 years |
| Dose-limiting toxicity（DLT） | Incidence and severity of dose-limiting toxicities. | Through study completion, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, assessed up to 2 years. |
| Radiographic Progression-free Survival (rPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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.
Known other malignancies.
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.
Patients with a history of Central Nervous System (CNS) metastases.
Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | 100023 | China |
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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. |
| Through study completion, assessed up to 2 years. |
| 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. | Through study completion, assessed up to 2 years. |
| 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 . | Through study completion, assessed up to 2 years. |
| Disease Control Rate (DCR) | Disease control rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1. | Through study completion, assessed up to 2 years. |