Real-World outcomes of Darolutamide + docetaxel + androgen deprivation therapy combination in patients with metastatIc castration sensitive prostate cancer within the Italian multicenter observational study (ECHOS trial)

Introduction: ARASENS study demonstrated that mCSPC patients treated with DAROLUTAMIDE+DOCETAXEL+ANDROGEN DEPRIVATION THERAPY triplet achieve a significant overall survival (OS) improvement compared to ADT+DOC. ECHOS is a multicenter observational study open since 2014 and collecting real-world data of mCSPC pts treated in Italy, where DARO became available from Feb 2023 to Mar 2024 within a compassionate use programme. Materials and methods: In the present analysis we evaluated outcomes of 178 mCSPC pts enrolled in ECHOS trial and treated with DARO+DOC+ADT, using as reference the consecutive series of 924 mCSPC patients previously enrolled in ECHOS trial and treated with DOC+ADT. Results: Median age of pts treated with DARO was 68 yrs (range 49-84 with 39.3% ≥ 70 yrs). Most of patients (73.3%) showed features of metastatic high volume de novo disease according to CHAARTED criteria. A Gleason score ≥ 8 was detected in 83.1% of the pts. Median baseline PSA level was 79.1 ng/mL (range 0.2-6,801). At the time of the present analysis, DOC is still ongoing in 36 pts, in the remaining 142 pts the planned number of six DOC courses were completed in 88% of the cases (compared to 89% of the DOC+ADT group). The rate of pts experiencing a disease progression within 7 mo from the treatment start was 4.5% (compared to 12.6% of the DOC+ADT pts, p=0.001). After a median follow-up of 6.6 mos the 1-year PFS and OS rates were 87.3% and 94.6%, respectively. Conclusions: The combination of DARO+DOC+ADT is well tolerated in real world mCSPC patients with lower rates of early progression compared to DOC+ADT. Mature results in terms of PFS and OS outcomes will be available with longer follow-up.