Patient selection for triplet therapy with darolutamide in metastatic castration-sensitive prostate cancer and patterns of administration: a Spanish multicenter study.

BACKGROUND

Triplet therapy with androgen deprivation therapy (ADT), docetaxel, and darolutamide is approved for treating patients with metastatic castration-sensitive prostate cancer (mCSPC) based on the results of the ARASENS trial. However, no guideline exists for patient selection beyond patient fitness for chemotherapy, personal preferences, disease volume, and metastases presentation. Evidence on patient selection and treatment administration in clinical practice is scarce.

PATIENTS AND

METHODS

Prospective, multicenter study conducted in Spain between November 2023 and June, 2024 in mCSPC patients selected for triplet therapy. Sociodemographic and clinical characteristics of patients at primary diagnosis, disease-related characteristics and symptoms at mCSPC diagnosis, and information on triplet therapy administration were collected. Descriptive statistics were used.

RESULTS

During the study period, 105 patients from 15 Spanish hospitals were included in the study. The median age was 66 years (range 44-85). Ninety-three patients (88.6%) had synchronous disease. Most patients had ECOG-PS 0/1 (90.4%). Ninety-two (87.6%) patients had high-volume disease and 96 (91.4%) high-risk disease. Five (4.5%), 70 (67.3%), and 29 (27.8%) patients had M1a, M1b, and M1c disease, respectively. Bone (77.1%) and pelvic lymph node (70.5%) were the most frequent metastatic locations. Docetaxel and darolutamide were simultaneously initiated in 39 (37.1%) patients.

CONCLUSION

As in the ARASENS trial, most patients offered triplet therapy in this representation of Spanish clinical practice were young and had synchronous disease. However, poorer disease characteristics, such as high-volume, high-risk disease, and involvement of visceral metastases, were more frequent. The rate of simultaneous initiation of darolutamide and docetaxel was low.