Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP)

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 REGISTRATION: www.clinicaltrials.gov identifier is NCT05794906.

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Publication Details

Journal
Future Oncology
Published
2025-11-11
DOI
https://doi.org/10.1080/14796694.2025.2577633
Primary Topic
Prostate Cancer Treatment and Research
Type
article
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article

Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP)

Karim S. Fizazi, Bernardo Herrera‐Imbroda, Tamim Niazi, Miryana Dimova-Dobreva et al.
Future Oncology
Prostate Cancer Treatment and Research
article

Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP)

Karim S. Fizazi, Bernardo Herrera‐Imbroda, Tamim Niazi, Miryana Dimova-Dobreva, Philippe Barthélémy, Koji Hatano, Matthieu Gratton, Andrea Juliana Gomes, Ashley E. Ross, Iris Kuss, Stéphane Supiot, Alex Chehrazi‐Raffle, Soichiro Yoshida, Martin Andreas Røder, Marie‐Aude Le Berre, Jürgen E. Gschwend, Alicia Katherine Morgans, Thomas A. Hope, Carmen Belen Congregado Ruiz, Neal D. Shore, Heikki Joensuu
article en

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 REGISTRATION: www.clinicaltrials.gov identifier is NCT05794906.

Future OncologyVol. 21(27)
Northwestern University (US), University of Copenhagen (DK), Bayer (United States) (US), Université Paris-Saclay (FR), McGill University Health Centre (CA), Institut Gustave Roussy (FR), TUM Klinikum (DE), Osaka City University (JP), Shanghai Institute for Science of Science (CN), Star Technology and Research (United States) (US), Liga Contra el Cancer (PE), Institut de Cancérologie de l'Ouest (FR), City of Hope (US), Dana-Farber Cancer Institute (US), Orion Corporation (Finland) (FI), Bayer (Switzerland) (CH), Hospital Universitario Virgen del Rocío (ES), Instituto de Biotecnología y Biología Molecular (AR), Hospital Clínico Universitario Virgen de la Victoria (ES), Instituto de Investigación Biomédica de Málaga (ES), Carolina Urologic Research Center (US), Bayer (France) (FR), Institute of Science Tokyo (JP), McGill University (CA), Bayer (Germany) (DE), Université de Strasbourg (FR), University of San Francisco (US), Orion Corporation (United Kingdom) (GB), The University of Osaka (JP)
Openalex Percentile: Top 51%
Prostate Cancer Treatment and Research
DOIOpen Access PDFOpenAlex
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