Darolutamide, in combination with androgen deprivation therapy (ADT) and docetaxel, has been proven effective in improving the overall survival of high-risk metastatic castration-sensitive prostate cancer (mCSPC). From May 1st, 2024, Darolutamide plus ADT and docetaxel therapy (Daro triplet therapy) has been reimbursed by Taiwan’s National Health Insurance (NHI) for high-risk mCSPC under a modified definition. This study aimed to present our experience with using Daro triplet therapy for the treatment of high-risk mCSPC in real-world clinical practice.

From February 2024 to February 2025, we enrolled patients who met the NHI’s modified definition of high-risk mCSPC: those who met 2 of the 3 criteria 1) Gleason score ≥ 8; 2) Bone scan reveals four or more lesions, with at least one lesion located outside the axial skeleton and pelvic region; 3) Presence of visceral metastasis. The patients received NHI-reimbursed Daro triplet therapy at our hospital (TPEVGH). The patients were regularly followed up with blood tests and imaging studies, including either computed tomography, sonography, and whole body bone scans every 3 months. The clinical responses and adverse events (AEs) were recorded.

A total of 20 patients were enrolled in our study since February 2024. The mean age was 68.1 ± 1.706 years (range 49-81) and 95% exhibited Eastern Cooperative Oncology Group (ECOG) performance status 0. Among them, 14 patients completed 6 cycles of docetaxel, 4 patients are currently undergoing docetaxel treatment, and 2 patients discontinued docetaxel due to adverse events. All patients met the high-risk criteria; 4 patients (20%) met all three high-risk criteria and 16 patients (80%) met 2 of the 3 criteria. The median follow-up period was 7.5 months (IQR: 4-12). Eighteen patients (90%) were still on treatment as of February 2025, with a median treatment duration of 7.5 months. The PSA response rate at 3 months, defined as decline of PSA ≥ 50%, was 100%; 13 patients (65%) achieved PSA < 0.2 ng/mL. The median time to achieve PSA < 0.2 ng/mL was 4 months (IQR: 3-5). The common AEs were anemia (N=8, 40%) and skin rash (N=2, 10%). Elevated liver function tests were noted in 1 patient (5%). There was only one AE of CTCAE grade 3 in anemia and one grade 4 in neutropenia with respiratory failure.

Our preliminary real-world experience demonstrated a high PSA response rate for darolutamide in combination with ADT and docetaxel in the treatment of high-risk mCSPC. However, 2 patients experienced treatment related AEs and discontinued the medication. Prolonged follow-up is needed to assess long-term survival outcomes.