Morgans Alicia K, Chehrazi-Raffle Alex, Niazi Tamim, Shore Neal D, Ross Ashley E, Røder Andreas, Gomes Andrea Juliana, Supiot Stephane, Barthélémy Philippe, Hatano Koji, Ruiz Carmen Belen Congregado, Yoshida Soichiro, Herrera-Imbroda Bernardo, Gratton Matthieu, Gschwend Jürgen E, Hope Thomas A, Joensuu Heikki, Kuss Iris, Le Berre Marie-Aude, Dimova-Dobreva Miryana, Fizazi Karim
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
Future Oncol. 2025 Nov;21(27):3491-3498. doi: 10.1080/14796694.2025.2577633. Epub 2025 Nov 11.
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.
接受放射治疗（RT）或根治性前列腺切除术（RP）作为主要治疗手段的前列腺癌患者可能会出现生化复发（BCR），这需要有效的治疗来延缓疾病进展。ARASTEP研究（NCT05794906）旨在确定与安慰剂加雄激素剥夺疗法（ADT）相比，在高危BCR患者中，将达洛鲁胺添加到ADT中是否能使用前列腺特异性膜抗原正电子发射断层扫描/计算机断层扫描（PSMA PET/CT）改善无放射学进展生存期（rPFS）。全球243个地点的约970名患者将接受每日两次600毫克达洛鲁胺或安慰剂治疗，两者均联合ADT，持续24个月或直至疾病进展、出现不可接受的毒性或撤回同意书。符合条件的患者将接受过原发性RT或RP±辅助放疗（ART）或挽救性放疗（SRT），并呈现高危BCR（前列腺特异性抗原[PSA]倍增时间<12个月，RP[±ART/SRT]后PSA≥0.2 ng/mL或仅原发性RT后PSA高于最低点≥2 ng/mL）、≥1个PSMA PET/CT阳性病变（传统成像为阴性）、血清睾酮>150 ng/dL以及东部肿瘤协作组体能状态为0/1。主要终点是使用PSMA PET/CT的rPFS，次要终点包括无转移生存期、去势抵抗性前列腺癌发生时间、总生存期、生活质量和安全性。临床试验注册：www.clinicaltrials.gov标识符为NCT05794906。
