Trial reportCancer medicine2026
Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS.
Trial report in Cancer medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02200614 (A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide), which is not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
backgroundDarolutamide plus androgen-deprivation therapy (ADT) improved metastasis-free survival (MFS) by 2 years and reduced the risk of death by 31% in nonmetastatic castration-resistant prostate cancer (nmCRPC) in ARAMIS. Prior local therapy may influence the efficacy of subsequent systemic therapy. This post hoc analysis of ARAMIS evaluated the effect of prior local therapy on the efficacy and health-related quality of life (HRQoL) of darolutamide.
methodsPatients with nmCRPC were randomized to darolutamide (n = 955) or placebo (n = 554) while continuing ADT. MFS, overall survival (OS), time to prostate-specific antigen (PSA) progression, and HRQoL deterioration-free survival (DetFS) were estimated for patients with and without local therapy and by treatment using Kaplan-Meier methods.
resultsDarolutamide increased MFS versus placebo in patients with (HR, 0.36; 95% CI, 0.26-0.48) and without (HR, 0.46; 95% CI, 0.36-0.59) local therapy. Median OS was 48.6 months for placebo without local therapy and not reached in either the darolutamide group or placebo group with local therapy. Darolutamide 3-year OS rates were 86.9% (95% CI, 83.0-90.8) and 79.0% (95% CI, 66.2-78.1) in patients with and without local therapy, respectively. Darolutamide showed evidence of improved OS versus placebo in patients with prior local therapy (HR, 0.80; 95% CI, 0.50-1.30) and a greater effect in those without local therapy (HR, 0.67; 95% CI, 0.50-0.90). Darolutamide delayed time to PSA progression and HRQoL deterioration regardless of local therapy.
conclusionsDarolutamide versus placebo improved MFS, OS, time to PSA progression, and HRQoL DetFS independent of prior local therapy, consistent with the overall ARAMIS population.
trial registrationClinicalTrials.gov registration: NCT02200614.
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