Methods
death, Prostate Cancer
SECONDARY, PROSTATE CANCER
This is a secondary analysis of a multicenter randomized, open-label, phase 3 study in which patients with mCSPC, enrolled between March 1, 2013, and July 15, 2017, were randomly assigned in a 1:1 ratio to receive either androgen deprivation therapy (ADT) with orteronel 300 mg orally twice daily (experimental group) or ADT with bicalutamide 50 mg orally daily (control group). This secondary analysis only included patients who identified themselves as either Black or White. The NCI’s central institutional review board approved the study. The study was conducted in accordance with the International Conference on Harmonization of Good Clinical Practice guidelines and the principles of the Declaration of Helsinki.The categorization of race was based on patient self-report. The primary end point was OS, defined as the time from randomization to death from any cause. Secondary end points included progression-free survival (PFS) and prostate-specific antigen (PSA) response rate at 7 months. PFS was defined as the time from randomization to biochemical, radiographic, or clinical progression (per Prostate Cancer Working Group 2 criteria) or death from any cause. PSA responses were categorized as complete response (CR; PSA below 0.2 ng/mL), partial response (PR; PSA between 0.2 and 4.0 ng/mL), and no response (NR; PSA above 4.0 ng/mL [to convert PSA to micrograms per liter, multiply by 1]). A detailed methodology and the primary results of the trial have been previously published (