A single-arm pilot study to investigate tumor absorbed dose dynamics and feasibility of pre-treatment dosimetry with [177Lu]-PSMA-I&T in male participants aged ≥ 18 years with metastatic castration-resistant prostate cancer

Condition studied

Metastatic castration-resistant prostate cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Tumor dose per treatment cycle (post-therapeutic dosimetry)

Endpoint detail

Tumor dose per treatment cycle (pre-therapeutic dosimetry), Absolute and percentage changes from baseline in tumor volume and SUV, Incidence, severity, seriousness, and relationship to study intervention of adverse events and serious adverse events; clinically significant changes in laboratory parameters, vital signs, and physical examination findings, Exploratory: Association between tumor absorbed dose and changes from baseline in tumor volume and SUV, Exploratory: Changes from baseline in PET kinetic parameters and blood-based biomarkers