Phase 1 Dose-Escalation Study of 225 AcAc-PSMA I&T in Patients with Metastatic Castration-Resistant Prostate Cancer: An Analysis of Safety, Tolerability, and Dosimetry

Key Points

• This research aims to evaluate the safety, tolerability, and dosimetry of 225Ac-PSMA I&T in patients with metastatic castration-resistant prostate cancer.
• Nine patients received escalating doses of 225Ac-PSMA I&T across two treatment cycles.
• Adverse events were monitored closely, and tumor responses evaluated through PET/MRI imaging.
• Dosimetry included blood and urine sampling at various time points and planar imaging.
• Adverse events occurred in 8 out of 9 patients, with xerostomia, anemia, and malaise being the most common.
• A recommended phase 2 dose of 10 MBq was established after observing dose-limiting toxicities.
• 44% of patients showed a prostate-specific antigen response of 50% or greater.

Abstract