Abstract
PURPOSE: To evaluate the efficacy and safety of triplet therapy in patients with metastatic hormone-sensitive prostate cancer (mHSPC), focusing on older adults, in a real-world clinical setting. METHODS: In this retrospective, single-center study, we analyzed data from 21 patients with mHSPC (median age: 71 years) treated with androgen deprivation therapy (ADT), docetaxel, and darolutamide. Relative (≥ 90% reduction from baseline) and absolute (PSA < 0.2 ng/mL) prostate-specific antigen (PSA) response rates over 6 months were assessed, along with adverse event (AE) profiles. RESULTS: At 6 months, the absolute PSA response rate was 71.4%, while the relative PSA response rate reached 100% by 3 months. Treatment-related toxicity was notable, with AEs observed in 95.2% of the patients, predominantly neutropenia. Patients aged ≥ 80 years had significantly higher treatment interruption rates for both docetaxel and darolutamide compared with those aged ≤ 79 years. Nonetheless, PSA response rates were comparable between the age groups. Neutrophil recovery time was significantly prolonged in patients aged ≥ 80 years compared to those aged ≤ 79 years. CONCLUSION: Triplet therapy effectively reduces PSA in patients with mHSPC, including older adults. However, the high incidence of severe AEs, particularly in older adults, underscores the need for individualized treatment strategies. Despite these challenges, careful management of toxicities makes this regimen viable in clinical practice. These findings emphasize the importance of real-world data in optimizing therapy for aging populations and may serve as a basis for future prospective studies comparing triplet and doublet therapies across diverse patient cohorts.