Darolutamide is a next-generation androgen receptor inhibitor, used in the treatment of prostate cancer. There is currently limited real-world data available on its efficacy and safety. In our research, we collected real-world data to evaluate the effectiveness and safety of darolutamide in patients with non-metastatic and metastatic hormone-sensitive prostate cancer.

This study retrospectively collected baseline information from patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and metastatic hormone-sensitive prostate cancer (mHSPC) who received darolutamide treatment at Drum Tower Hospital between January 2022 and January 2024. We recorded the time at which patients reached their lowest PSA levels and documented information of treatment discontinuation, dosage reduction, and adverse events during the treatment.

A total of 188 patients were included: 71% (n=133) with nmHSPC and 29% (n=55) with mHSPC. Both groups reached the lowest PSA levels in a median of 5 months, with most patients achieving a PSA90 reduction. At 12 months, biochemical progression-free survival(bPFS) rates were 72.8% for nmHSPC and 91% for mHSPC. Discontinuation due to voluntary choice was 2.3% (n=3) for nmHSPC and 1.8% (n=1) for mHSPC; due to insufficient efficacy, 0.8% (n=1) for nmHSPC and 7% (n=4) for mHSPC. Adverse events led to dose reductions in 4.5% (n=6) of nmHSPC and 1.8% (n=1) of mHSPC patients. Surgical data for 51.1% (n=68) of nmHSPC patients showed 81% (n=55) with negative margins, and 28% (n=19) achieved pathological complete response (pCR) or minimal residual disease (MRD). Common side effects included rash, fatigue, hot flushes, and sweating, with 7.4% (n=14) experiencing grade 2 adverse events and 0.5% (n=1) with grade 3.

Our real-world data demonstrates the effectiveness and safety of darolutamide in patients with nmHSPC or mHSPC.