This PubMed entry reports a phase III analysis titled "Clinically relevant endpoints and quality-of-life outcomes with darolutamide in patients with metastatic hormone-sensitive prostate cancer: Analyses of the phase III ARASENS trial." The article is indexed in Eur J Cancer, listed as a Clinical Trial and a free article. Publication details provided on the record include Epub 2026 Jun 12 and journal issue reference 2026 Aug 26:244:116888. The PubMed identifier is PMID 42378957 and the DOI is 10.1016/j.ejca.2026.116888. A link to Elsevier Science full-text options appears on the PubMed page.
The record lists Karim Fizazi as first author and includes a multi-author byline with investigators from academic cancer centers, urology departments, and industry. Notable institutional affiliations reported in the PubMed entry include Centre Oscar Lambret and Institute Gustave Roussy (France), Massachusetts General Hospital and Harvard Medical School (USA), Northwestern University Feinberg School of Medicine (USA), University of Montreal Hospital Center (Canada), Weill Cornell Medicine (USA), UC San Diego School of Medicine (USA), Dana-Farber Cancer Institute (USA), and additional clinical and industry-based affiliations such as Orion and Bayer. The full author list reflects collaboration between academic investigators and sponsor-affiliated contributors.
The PubMed record identifies the work as analyses from the phase III ARASENS trial examining clinically relevant endpoints and patient-reported quality-of-life outcomes associated with darolutamide treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The title explicitly frames the analysis around clinically relevant endpoints and QoL, indicating the manuscript addresses both traditional clinical measures and patient-centered outcomes. Beyond the title, the PubMed entry does not provide the trial protocol, eligibility criteria, dosing, comparator, follow-up duration, prespecified endpoints, or analytic populations in the visible content.
The PubMed page includes a link to Elsevier Science full-text options and is marked as free article in the metadata. The record shows the DOI and provides a route to access the journal copy where full methods, results, tables, figures, and supplementary material should be available. For clinicians who need to evaluate the study in detail (trial design, randomization, baseline demographics, QoL instruments used, statistical methods, primary and secondary endpoint results, subgroup analyses, and safety data), consulting the full-text article via the provided link or institutional access is necessary.
Reported in this PubMed record:
Not reported in this PubMed record (details not available in the provided source):
Because these important methodological and outcome details are not included in the PubMed abstract text available in the provided source, they cannot be inferred or summarized here.
Use the DOI (10.1016/j.ejca.2026.116888) or the Elsevier link on the PubMed page to retrieve the full text from the journal (Eur J Cancer). The PubMed record indicates a full-text link and lists the article as free; follow that route to read the complete report.
In the full text, locate the Methods section for trial design, randomization, eligibility, interventions (darolutamide dosing and background therapy), and specified primary and secondary endpoints. Confirm which endpoints the authors classify as "clinically relevant."
Review the Results for patient disposition, baseline characteristics, primary and secondary endpoint outcomes, patient-reported quality-of-life data (instruments used, timepoints, and statistical analyses), and safety/adverse-event reporting.
If the full-text article remains inaccessible, consider requesting the article through institutional library services or contacting the corresponding author (email provided in the PubMed record for the first author) for additional information or a copy.
For guideline or practice-impact considerations, cross-check any reported outcomes in the full text with existing clinical guidelines for management of mHSPC and with the original ARASENS trial primary publication(s) if available.
Note on source material: this clinical summary is strictly limited to bibliographic and descriptive information present in the PubMed record supplied. The PubMed entry identifies the study focus and metadata but does not include methods or outcome data in the visible snippet; therefore, specific trial results, statistical findings, and authors’ conclusions were not reported in the source and are not presented here.