Status:
RECRUITING
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
Lead Sponsor:
Xiaorong Sun
Conditions:
Metastatic Castration-Resistant Prostate Cancer Patients
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07135102
Start Date
October 14 2024
End Date
June 1 2027
Last Update
August 24 2025
Active Locations (1)
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1
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 100023