The treatment regimen will consist of 4 doses of 225Ac-PSMA-I&T, administered at 8 ± 1 week intervals, with an initial activity of 100 kBq/kg (±10%).~Additional doses will be administered at 100 kBq/kg (±10%) with the following exceptions:~Patients who experience dose-modifying events should be managed as outlined in Table 6.~Patients with a confirmed decline in PSA ≥ 50% (2 consecutive measurements at least 3 weeks apart) should have their dose of 225Ac-PSMA-I&T de-escalated to 87 kBq/kg(±10%).~Additional de-escalations to 75 kBq/kg (±10%) then 50 kBq/kg (±10%) will be taken if PSA continues to decline > 85%.~225Ac-PSMA-I&T will be administered as an intravenous (I.V.) infusion over approximately 1-3 minutes.
The treatment regimen will consist of 4 doses of 225Ac-PSMA-I&T