Study Objectives
| Objective | Description |
|---|---|
| Primary | |
| Phase I | To establish maximum tolerated dose, DLTs, and recommended phase II dose of [161Tb]Tb-PSMA-I&T in patients with mCRPC |
| Phase II | To evaluate safety of [161Tb]Tb-PSMA-I&T in patients with mCRPC |
| Secondary | To establish absorbed radiation dose (Gy) in normal tissue and sites of metastatic disease after 1 cycle of [161Tb]Tb-PSMA-I&T |
| To evaluate antitumor activity of [161Tb]Tb-PSMA-I&T in patients with mCRPC by… | |
| PSA response rate | |
| Radiographic progression-free survival | |
| PSA progression-free survival | |
| Progression-free survival | |
| Overall survival | |
| Objective response rate | |
| To evaluate health-related quality of life within 12 mo of treatment commencement | |
| To evaluate pain within 12 mo of treatment commencement | |
| Exploratory | To evaluate associations among [68Ga]Ga-PSMA-11 or [18F]DCFPyL PET/CT, [18F]FDG PET/CT, posttherapy SPECT/CT, baseline characteristics, and outcomes |
| To evaluate dynamic changes in circulating tumor DNA fraction and utility of circulating tumor DNA genomic aberrations as predictive biomarker of response | |
| To evaluate molecular alterations in tissue and their correlation with clinical outcome | |
| To evaluate treatment-related quality of life using Functional Assessment of Cancer Therapy–Radionuclide Therapy questionnaire within 12 mo of treatment commencement |