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
Recruiting now · Phase 1
Conditions studied: Metastatic Castration-Resistant Prostate Cancer Patients
In brief
The purpose of this study is to determine the safety and efficacy of 225Ac -labeled PSMA ligand(PSMA-XT) in the treatment of mCRPC
Key facts
- Study ID
- NCT07135102
- Run by
- Xiaorong Sun
- People needed
- 40
- Starts
- 2024-10-14
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-08-24
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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