Recruiting NCT07135102

A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer

Phase I Interventional Metastatic Castration-Resistant Prostate Cancer Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 225Ac-PSMA-XT.
Who it may be relevant to: Registry conditions: Metastatic Castration-Resistant Prostate Cancer Patients. Basic parameters: from 18 years · Male.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC

Drug 225Ac-PSMA-XT
Patients will receive 225Ac-PSMA-XT administration at an interval of 6 weeks between each dose.

Treatment emergent adverse events [Time frame: Through study completion, assessed up to 2 years]
Dose-limiting toxicity（DLT） [Time frame: Through study completion, assessed up to 2 years]

Secondary outcome measures (5)

Prostate-specific Antigen 50 (PSA50) Response [Time frame: Through study completion, assessed up to 2 years.]
Radiographic Progression-free Survival (rPFS) [Time frame: Through study completion, assessed up to 2 years.]
Overall Response Rate (ORR) [Time frame: Through study completion, assessed up to 2 years.]
Duration of Response (DOR) [Time frame: Through study completion, assessed up to 2 years.]
Disease Control Rate (DCR) [Time frame: Through study completion, assessed up to 2 years.]

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.
have histological, pathological, and/or cytological confirmation of prostate cancer.
PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive
have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
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.
progressive mCRPC.
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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT07135102 · SDZLEC2024-365-01