Table 2.

Secondary and exploratory objectives.

Secondary objectives

• To evaluate the safety of 223Ra in combination with [177Lu]Lu-PSMA-I&T in patients with mCRPC through assessing the frequency and severity of AEs as per Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0). • Radiographic PFS (rPFS). • PSA-PFS. • PFS. • OS. • Objective Response Rate (ORR). • To evaluate changes in health-related quality of life (HR-QoL) using FACT-P and pain using BPI-SF within 12 months of treatment commencement.

Exploratory objectives

• Time to ALP response. • Time to ALP progression. • Associations between imaging (PSMA PET/CT, FDG PET/CT, bone scan SPECT/CT, and post therapy SPECT-CT) and baseline characteristics and outcomes. • Dynamic changes in circulating tumor DNA (ctDNA) fraction and utility of ctDNA genomic aberrations as a predictive biomarker of response. • Changes to circulating and tumor infiltrating immune cells post therapy and their association with clinical outcome.