eligibility_summary
Eligible: progressive metastatic CRPC (castrate T) with PSA, soft-tissue, bone, or PSMA-PET progression, M1 on CT/MRI/bone scan or on PSMA-PET, PSMA-PET positive only, prior ADT and >=1 ARSI, antiresorptives if bone mets, well-controlled HIV OK. Part 3: prior Lu-177-PSMA and <=1 taxane allowed. Exclude: superscan, other active malignancy <3 y, prior platinum, PARPi, radiopharms, anticoagulants/antiplatelets that can’t be held. Part 2: no CRPC chemo/radiopharm/PSMA therapy, HSPC taxane OK if >=1 y prior. Part 3: no PSMA therapy except Lu-177.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Rosopatamab tetraxetan, an anti-PSMA IgG monoclonal antibody (radioimmunotherapy) chelated with tetraxetan and radiolabeled with either In-111 (diagnostic) or Ac-225 (therapeutic). In-111-rosopatamab tetraxetan is a SPECT imaging/dosimetry agent to characterize biodistribution. Ac-225-rosopatamab tetraxetan is targeted alpha therapy, antibody binding to PSMA delivers actinium-225 alpha emissions to tumor sites, causing high-LET DNA double-strand breaks and tumor cell death. Targets: PSMA (glutamate carboxypeptidase II) on PSMA PET-positive metastatic CRPC cells. Pathway/cellular effect: antigen-specific delivery of alpha radiation leading to direct cytotoxicity of PSMA-positive prostate cancer cells and nearby microenvironment. Study optimizes fractionated dosing (45–60 kBq/kg) and escalates doses, including post-Lu-177-PSMA patients.