Brief Summary

This clinical trial will evaluate the safety and efficacy of \[161Tb\]Tb -PSMA-I\&T in men with metastatic castration-resistant prostate cancer (mCRPC).

Conditions

• Prostate Cancer
• Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment

• Drug: [ 161 Tb]Tb PSMA I&T

Primary Outcome Measures

• Maximum Tolerated dose (MTD) (Dose escalation phase is expected to be completed 6 months from the time the first patient is recruited.)
  The MTD is defined as the highest dose level at which the incidence of DLT was less than 1/3 or 2/6.
• Adverse Events (AEs) and Serious Adverse Events (SAEs) measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 (Through study completion, up until 12 months after the last patient commences treatment)
  Safety of the combination will be measured by AEs and SAEs.
• Dose Limiting toxicities (DLTs) (Dose escalation phase is expected to be completed 6 months from the time the first patient is recruited.)
  A DLT is defined as a toxicity that prevents further administration of the trial treatment at that dose level. Each cohort of 3 patients will be assessed for DLTs after 6 weeks from administration of cycle 1.
• Recommended Phase 2 Dose (RP2D) (Up to 30 months from the time the first patient is recruited.)
  After the MTD is established, additional patients will be treated at the MTD. Safety and efficacy data from the study will be used to define the RP2D.

Countries

Australia

Locations and Investigators

• Peter MacCallum Cancer Centre, Melbourne, Australia (Recruiting)
  • James Buteau, MD