ArticleFuture oncology (London, England)2025
Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP).
Article in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05794906 (A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy), which is not on this map. Cited by 3 papers.
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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 Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer
Who cites it
3 citing papers in PubMed.
- Redefining the standard of care for high-risk biochemical recurrence of prostate cancer after definitive therapy: insights from the EMBARK final analysis.Translational andrology and urology · 2026Article
- Real-world clinical outcomes in patients with biochemical recurrence after local therapy for non-metastatic prostate cancer.Future oncology (London, England) · 2026Observational
- Article
Corrections and comments
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Patients with prostate cancer treated with radiotherapy (RT) or radical prostatectomy (RP) as primary therapy may develop biochemical recurrence (BCR), which requires effective treatment to delay disease progression. The ARASTEP study (NCT05794906) aims to determine whether the addition of darolutamide to androgen-deprivation therapy (ADT) improves radiologic progression-free survival (rPFS) using prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) compared with placebo plus ADT in patients with high-risk BCR.Approximately 970 patients from 243 sites globally will receive either darolutamide 600 mg or placebo twice daily, both with ADT, for 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent. Eligible patients will have been treated by primary RT or RP ± adjuvant RT (ART) or salvage RT (SRT), and present with high-risk BCR (prostate-specific antigen [PSA] doubling time <12 months and PSA ≥0.2 ng/mL after RP [± ART/SRT] or PSA ≥2 ng/mL above nadir after primary RT only), ≥1 PSMA PET/CT-positive lesion (negative on conventional imaging), serum testosterone >150 ng/dL, and Eastern Cooperative Oncology Group performance status 0/1. The primary endpoint is rPFS using PSMA PET/CT, with secondary endpoints including metastasis-free survival, time to castration-resistant prostate cancer, overall survival, quality of life, and safety.CLINICAL
trial registrationwww.clinicaltrials.gov identifier is NCT05794906.
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