EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T
Trial Parameters
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).
Eligibility Criteria
Inclusion Criteria: 1. Patient has provided written informed consent. 2. Male patients must be 18 years of age or older at the time of written informed consent. 3. Histologically or cytologically confirmed adenocarcinoma of the prostate, OR unequivocal diagnosis of metastatic prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) with an elevated serum prostate specific antigen (PSA). 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 5. Patients must have had prior treatment with at least one line of taxane chemotherapy, unless medically unsuitable. 6. Patients must have had prior treatment with at least one second-generation androgen receptor (AR)-targeted agent (e.g., enzalutamide, abiraterone, apalutamide or darolutamide). 7. Patients must have progressive disease defined according to The Prostate Cancer Clinical Trials Working Group 3 (PCWG3) as any one of the following: 1. PSA progression - minimum of 2 rising PSA values from a b