SESAUA 2024: Darolutamide in Combination with ADT and Docetaxel: Efficacy and Safety by Disease Volume and Risk in the Phase 3 ARASENS Trial

( The 2024 Southeastern Section of the AUA (SESAUA) annual meeting featured a prostate cancer session and a presentation by Dr. Evan Goldfischer discussing efficacy and safety by disease volume and risk in the phase 3 ARASENS trial. In patients with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic disease burden is a prognostic factor. Darolutamide + ADT + docetaxel was shown to significantly reduce the risk of death by 32.5% (HR 0.68; 95% CI: 0.57–0.80; p < 0.0001) versus placebo + ADT + docetaxel in patients with mHSPC in the ARASENS trial.1 Outcomes based on disease volume and risk provides additional information to clinicians when making decisions about treatment intensification for patients with mHSPC. At the 2024 SESAUA annual meeting, Dr. Goldfischer and colleagues compared the outcomes of patients stratified into high/low disease volume and high/low risk subgroups.

Patients with mHSPC were randomized 1:1 to darolutamide 600 mg twice daily or placebo, with ADT + docetaxel:


High-volume disease was defined as patients with visceral metastases and/or ≥4 bone metastases with ≥1 beyond the vertebral column/pelvis (CHAARTED criteria). High-risk disease was defined as patients with ≥2 risk factors: Gleason score ≥8, ≥3 bone lesions, and the presence of measurable visceral metastasis (LATITUDE criteria). Overall survival for these subgroups was assessed using an unstratified Cox regression model.

Of 1,305 patients, 1,005 (77%) had high-volume disease, 912 (70%) had high-risk disease, 300 (23%) had low-volume disease, and 393 (30%) had low-risk disease. Darolutamide + ADT + docetaxel prolonged overall survival regardless of high- or low-volume disease with HRs of 0.69 and 0.68 versus placebo + docetaxel + ADT, respectively. A similar overall survival benefit for darolutamide + ADT + docetaxel versus placebo was observed for patients with high- or low-risk disease:


Darolutamide improved clinically relevant secondary endpoints versus placebo in high-/low-volume and risk subgroups, including time to CRPC, with HRs generally in the range of those observed in the overall population:


The incidence of treatment emergent adverse events was consistent with the overall ARASENS population across subgroups by high/low volume and high/low risk.

Dr. Goldfischer concluded his presentation by discussing efficacy and safety by disease volume and risk in the phase 3 ARASENS trial with the following conclusions:

  • The combination of darolutamide + ADT and docetaxel improved overall survival, with the risk of death reduced by ~30% across disease volume and risk subgroups
  • Median overall survival was not reached in the darolutamide group regardless of disease volume or risk
  • The favorable safety profile of darolutamide was confirmed in all volume and risk subgroup populations, consistent with the overall survival in the ARASENS population

Presented by: Evan Goldfischer, MD, MBA, FACS, Premier Medical Group, Poughkeepsie, NY

Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2024 Southeastern Section of the American Urological Association (SESAUA) Annual Meeting, Austin, TX, Wed, Mar 20 – Sat, Mar 23, 2024. 


  1. Smith MR, Hussain M, Saad F, et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142.