Tests a radioactive drug in men with advanced prostate cancer
Tests 225Ac-PSMA-XT, a radioactive drug, in adults with metastatic castration-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Jinan, ChinaSee the site
- Phase
- Phase 1
Where in China
- Cancer Hospital of Shandong First Medical UniversityJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xiaorong Sun
- Trial code
- NCT07135102
- Record updated
- 24 August 2025
- Original description
The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPCRead full original descriptionShow less
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
The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC
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; 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; A superscan as seen in the baseline bone scan.