Outcomes
toxicities, death, fracture
EVENT, SPINAL CORD COMPRESSION
The primary endpoint in part A was to determine the recommended phase 2 dose schedule of the treatment combination, based on the occurrence of dose-limiting toxicities, aggregate safety data, and feasibility of administration. The primary endpoint in part B was objective response rate (ORR) per investigator assessment by RECIST (version 1.1) criteria using cross-sectional imaging of the chest, abdomen and pelvis obtained at 9-week intervals, confirmed by repeat measurement. Secondary endpoints evaluated in the overall cohort were safety and dose-limiting toxicities (as defined above), median duration of response, the proportion of patients who had a decrease in prostate-specific antigen (PSA) of 50% or more (PSA50) from baseline, median PSA progression-free survival, median radiographic progression-free survival, 6-month radiographic progression-free survival, median time to symptomatic skeletal related event (SSRE), and median overall survival. Progression-free survival was defined as the time from the start of protocol therapy to radiographical progression as per PCWG3 criteria, clinical progression, or death, whichever occurred first; PSA progression was defined as time to date of first PSA measurement meeting criteria for progression by PCWG3; time to SSRE was defined as the time to first occurrence of symptomatic fracture, surgery or radiation to the bone, or spinal cord compression. Duration of response was defined as time from date of first objective response on imaging until the date of progression. Overall survival was defined as time from date of first treatment on study to death from any cause.Prespecified exploratory endpoints were lesion-specific response by uptake on screening 