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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorXiaorong Sun

About this trial

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

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Treatments tested in this trial

  • 225Ac-PSMA-XT

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Xiaorong Sun

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution