Background/Objectives: Treatment intensification with novel hormonal therapies is now standard in metastatic hormone-sensitive prostate cancer (mHSPC), but real-world patients are often more heterogeneous than those included in pivotal trials. This study aimed to describe clinical characteristics, safety, treatment discontinuation, disease progression, polypharmacy, and clinically documented drug–drug interactions in a real-world mHSPC cohort. Methods: We conducted a retrospective observational study including 109 patients with mHSPC who initiated abiraterone, enzalutamide, apalutamide, or docetaxel-based triplet regimens between January 2015 and November 2025. Outcomes included adverse events, discontinuation, PSA50 response at 3 months, time to progression and overall survival. Descriptive analyses and Kaplan–Meier estimates were performed. Results: Apalutamide was the most frequent first-line treatment (56.9%), followed by abiraterone (23.9%), enzalutamide (11.9%), darolutamide-based triplet therapy (3.7%), and abiraterone-based triplet therapy (3.7%). Median age was 73 years, and median baseline PSA was 16.1 ng/mL. De novo metastatic disease was present in 69.7% of patients, ISUP grade 4–5 disease in 58.7%, high-risk disease according to LATITUDE criteria in 45.9%, and high-volume disease according to CHAARTED criteria in 38.5%. The median Charlson Comorbidity Index was 4, and polypharmacy was observed in 68.8%. Adverse events occurred in 56.0%, and non-death treatment discontinuation occurred in 22.0%. No documented drug–drug interactions requiring treatment modification were recorded. PSA50 response was achieved by 97.2%. Thirteen patients (11.9%) progressed and 18 (16.5%) died. Median time to progression was not reached, and median overall survival was 53.2 months. Conclusions: Novel hormonal therapies were used in a clinically heterogeneous real-world mHSPC cohort. The findings support individualized treatment assessment and should be interpreted as descriptive and exploratory.
Millan-Ramos et al. (Fri,) studied this question.