Apalutamide use in metastatic hormone-sensitive prostate cancer patients diagnosed by conventional and next-generation imaging. Real world data from 772 patients

Introduction: Apalutamide has shown significantly increases in radiographic progression-free survival (rPFS) and overall survival (OS) in metastatic hormone-sensitive prostate cancer (mHSPC) patients diagnosed by conventional imaging (CI). However, there is scarce knowledge on the use of apalutamide in mHSPC population diagnosed by NGI. Methods: Retrospective multicenter study of mHSPC patients treated with apalutamide from May 2018 to September 2023 registered in the Real-World Evidence APA (RWE-APA). CI and NGI group were defined, according to the diagnostic tool of metastatic disease. Primary objective was rPFS at 24 months in CI vs NGI group. Secondary objectives were OS in CI vs NGI group and rPFS in synchronic/metachronic, low volume (LV)/high volume (HV) in CI and NGI groups and risk of developing new metastasis according to the imaging technique, metastasis volume and location of the metastasis. Results: 772 mHSPC patients were included. 47% (359) of patients were diagnosed with CI and 53% (413) of patients with NGI. rPFS at 24 months was 80% in the CI group vs 84% in the NGI group (Hazard ratio (HR): 0.57 (0.35 – 0.92) 95% Confidence Interval [CI], p = 0.023). OS at 24 months was 89.5% in the CI group and 95.8% in the NGI group (HR 0.35; 95% CI, 0.16 – 0.75, p = 0.007). In the multivariable analysis, only HV was significantly associated with metastatic progression (HR 0.33 (0.18-0.59) 95% CI; p ‹ 0.001). Conclusion: mHSPC patients treated with apalutamide and NGI-diagnosed exhibited superior rPFS and OS in comparison with CI-diagnosed patients.