Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Darolutamide Plus Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer by Disease Volume and Risk Subgroups in the Phase III ARASENS Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 111 papers, 7 of them syntheses that pooled it.
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The trial behind it
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Who cites it
111 citing papers in PubMed, 7 syntheses or guidelines pooled it, 200 citations in OpenAlex.
- The efficacy and safety of darolutamide combination therapy in advanced prostate cancer: a systematic review and meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2026Pooled it
- Comparative Survival in Metastatic Hormone-sensitive Prostate Cancer by Volume of Disease and Timing of Metastasis: A Living Network Meta-analysis.European urology · 2026Pooled it
- Cabazitaxel versus abiraterone or enzalutamide for metastatic castration-resistant prostate cancer following docetaxel failure: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Pooled it
- Cardiovascular events among men with prostate cancer treated with androgen receptor signaling inhibitors: a systematic review, meta-analysis, and network meta-analysis.Prostate cancer and prostatic diseases · 2025Pooled it
- Efficacy and safety evaluation of androgen deprivation therapy-based combinations for metastatic castration-sensitive prostate cancer: a systematic review and network meta-analysis.British journal of cancer · 2024Pooled it
- Impact of disease volume on survival efficacy of triplet therapy for metastatic hormone-sensitive prostate cancer: a systematic review, meta-analysis, and network meta-analysis.International journal of clinical oncology · 2024Pooled it
- Pooled it
- A phase I/II trial of concurrent chemo-hormonal enzalutamide and cabazitaxel in patients with metastatic castration-resistant prostate cancer.The oncologist · 2026Trial
- Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS.Cancer medicine · 2026Trial
- Tumor burden and heterogenous treatment effect of apalutamide in metastatic castration-sensitive prostate cancer.Cancer · 2025Trial
- Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Darolutamide in Japanese patients with metastatic hormone-sensitive prostate cancer: Phase 3 ARASENS subgroup analysis.Cancer medicine · 2024Trial
- Within-trial hospitalization resource utilization and budget impact analysis for darolutamide in metastatic hormone-sensitive prostate cancer using ARASENS.Journal of managed care & specialty pharmacy · 2024Trial
- Triplet therapy with darolutamide and docetaxel for metastatic castration-sensitive prostate cancer: a multicenter real-world study.Japanese journal of clinical oncology · 2026Article
- Genomic and transcriptomic correlates of deep prostate-specific antigen response in patients with metastatic androgen pathway modulation-sensitive prostate cancer.The oncologist · 2026Article
- Real-world evaluation of primary prophylactic use of granulocyte colony-stimulating factor in patients with metastatic castration-sensitive prostate cancer treated with triplet therapy.International journal of clinical oncology · 2026Article
- Androgen receptor pathway inhibitor intensification in non-metastatic hormone-sensitive prostate cancer: current evidence and clinical implications.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Clinical and genomic determinants of extraordinary response and resistance to androgen receptor pathway inhibitors in men with metastatic androgen pathway modulator sensitive (APMS) prostate cancer.Prostate cancer and prostatic diseases · 2026Article
- APUC-6 Genes as a Potential Prognostic and Predictive Biomarker in the CHAARTED Prostate Cancer Trial.JCO precision oncology · 2026Article
- Complete Response to Concurrent Triplet Therapy in Low-Volume Metastatic Hormone-Sensitive Prostate Cancer: A Case Report.IJU case reports · 2026Article
51 more citing papers are in PubMed but not listed here.
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Authors and funding
19 authors at 17 institutions in 11 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeFor patients with metastatic hormone-sensitive prostate cancer, metastatic burden affects outcome. We examined efficacy and safety from the ARASENS trial for subgroups by disease volume and risk.
methodsPatients with metastatic hormone-sensitive prostate cancer were randomly assigned to darolutamide or placebo plus androgen-deprivation therapy and docetaxel. High-volume disease was defined as visceral metastases and/or ≥ 4 bone metastases with ≥ 1 beyond the vertebral column/pelvis. High-risk disease was defined as ≥ 2 risk factors: Gleason score ≥ 8, ≥ 3 bone lesions, and presence of measurable visceral metastases.
resultsOf 1,305 patients, 1,005 (77%) had high-volume disease and 912 (70%) had high-risk disease. Darolutamide increased overall survival (OS) versus placebo in patients with high-volume (hazard ratio [HR], 0.69; 95% CI, 0.57 to 0.82), high-risk (HR, 0.71; 95% CI, 0.58 to 0.86), and low-risk disease (HR, 0.62; 95% CI, 0.42 to 0.90), and in the smaller low-volume subgroup, the results were also suggestive of survival benefit (HR, 0.68; 95% CI, 0.41 to 1.13). Darolutamide improved clinically relevant secondary end points of time to castration-resistant prostate cancer and subsequent systemic antineoplastic therapy versus placebo in all disease volume and risk subgroups. Adverse events (AEs) were similar between treatment groups across subgroups. Grade 3 or 4 AEs occurred in 64.9% of darolutamide patients versus 64.2% of placebo patients in the high-volume subgroup and 70.1% versus 61.1% in the low-volume subgroup. Among the most common AEs, many were known toxicities related to docetaxel.
conclusionIn patients with high-volume and high-risk/low-risk metastatic hormone-sensitive prostate cancer, treatment intensification with darolutamide, androgen-deprivation therapy, and docetaxel increased OS with a similar AE profile in the subgroups, consistent with the overall population.[Media: see text].
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.