Effectiveness and safety of hormonal doublet therapy in metastatic hormone-sensitive prostate cancer: A multicenter...

Hormonal doublet therapy is currently a standard treatment strategy for metastatic hormone-sensitive prostate cancer (mHSPC). Evidence from clinical trials and real-world studies has consistently demonstrated survival benefits.

To describe the clinical characteristics, diagnostic and therapeutic approach, oncological outcomes, and treatment tolerability in a multicenter cohort of patients with mHSPC treated with hormonal doublet therapy.

This multicenter retrospective study included patients diagnosed with mHSPC who received hormonal doublet therapy between 2017 and 2025. A descriptive analysis of clinical variables and efficacy and safety outcomes was performed. Statistical analyses were conducted using SPSS version 25.

A total of 1062 patients were included, with a median age of 72 years (IQR, 66-77) and a median follow-up of 26 months (IQR, 15-39). At diagnosis, 56% of patients had metastatic disease, and 49% had high-volume disease. In 41% of patients, the diagnosis was made using next-generation imaging. PSA ≤ 0.02 ng/mL was observed in 38% of patients at 6 months, increasing to 58% during follow-up. Median progression-free survival and overall survival were reached only in patients with high-volume disease (54 and 62 months, respectively). Treatment dose adjustment or temporary interruption was required in 22% of patients.

Hormonal doublet therapy demonstrated meaningful efficacy and an acceptable safety profile in patients with mHSPC, with results consistent with those reported in contemporary cohorts.