短期达罗鲁胺(ODM-201)与放疗同时用于中危前列腺癌患者:Darius(AFU-GETUG P15)2期试验方案。

IF 8.3 1区 医学 Q1 ONCOLOGY European urology oncology Pub Date : 2024-05-15 DOI:10.1016/j.euo.2024.04.023
Paul Sargos, Carine Bellera, Rita Bentahila, Marie Guerni, Nicolas Benziane-Ouaritini, Diego Teyssonneau, Nam-Son Vuong, Guillaume Ploussard, Morgan Roupret, Guilhem Roubaud
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引用次数: 0

摘要

背景:雄激素剥夺疗法(ADT)与体外放射治疗(EBRT)相结合是中危前列腺癌(PCa)患者的标准治疗方法。然而,6 个月的 ADT 会产生多种副作用,影响生活质量(QoL)。达罗他胺(雄激素受体靶向药[ARTA])的血脑屏障穿透性低,药物间相互作用少:目的:评估6个月达罗鲁胺联合EBRT治疗不利中危PCa患者的疗效:DARIUS试验是一项多中心随机非比较性2期试验,在不利中危PCa患者中随机分组6个月达罗鲁胺+EBRT与6个月ADT+EBRT:主要终点是生物反应,即服用达罗鲁胺或ADT第6个月时前列腺特异性抗原≤0.1 ng/ml。主要次要终点是无生化复发生存期、无疾病生存期、安全性和 QoL。计划使用放射组学和基因组分类器进行辅助研究。将纳入 62 名患者:在需要ADT联合EBRT的患者中,单独使用ARTA(如达洛他胺)可能会显示出抗肿瘤疗效,同时将毒性降至最低并保持QoL。本研究的局限性主要在于其开放标签设计:患者摘要:正在进行的 DARIUS 临床试验评估了达罗鲁胺短期(6 个月)治疗与局部前列腺癌男性患者体外放射治疗的结合情况。该试验研究单药达罗鲁胺是否能改善生物反应,同时保持良好的耐受性。
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Short-term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients with Unfavorable Intermediate-risk Prostate Cancer: The Darius (AFU-GETUG P15) Phase 2 Trial Protocol.

Background: Combination of androgen deprivation therapy (ADT) with external beam radiation therapy (EBRT) is a standard of care for patients with intermediate-risk prostate cancer (PCa). However, 6 months of ADT generates multiple side effects impacting quality of life (QoL). Darolutamide (an androgen receptor targeting agent [ARTA]) is associated with low blood-brain barrier penetrance and less drug-drug interaction.

Objective: To assess the efficacy of a combination of 6 months of darolutamide with EBRT to treat patients with unfavorable intermediate-risk PCa.

Design, setting, and participants: The DARIUS trial is a multicenter randomized non comparative phase 2 trial, randomizing the 6-months darolutamide + EBRT arm versus 6-months ADT + EBRT in patients with unfavorable intermediate-risk PCa.

Outcome measurements and statistical analysis: The primary endpoint is a biological response defined as prostate-specific antigen ≤0.1 ng/ml at month six of darolutamide or ADT. The key secondary endpoints are biochemical recurrence-free survival, disease-free survival, safety, and QoL. Ancillary studies using radiomics and genomic classifier are planned. Sixty-two patients will be included.

Results and limitations: In this population of patients requiring ADT combined with EBRT, the use of an ARTA alone, such as darolutamide, may demonstrate antitumoral efficacy while minimizing toxicity and maintaining QoL. Limitations are mainly inherent to the open-label design of this study.

Conclusions: Six months of darolutamide + EBRT compared with 6 months of ADT + EBRT may be efficient in terms of a biological response, avoiding toxicity and altered QoL attributable to ADT in patients with unfavorable intermediate-risk PCa.

Patient summary: The ongoing DARIUS clinical trial assesses short-term (6 months) darolutamide treatment in association with external beam radiation therapy in men with localized prostate cancer. The trial investigates whether single-agent darolutamide can improve the biological response while maintaining a favorable tolerability profile.

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来源期刊
CiteScore
15.50
自引率
2.40%
发文量
128
审稿时长
20 days
期刊介绍: Journal Name: European Urology Oncology Affiliation: Official Journal of the European Association of Urology Focus: First official publication of the EAU fully devoted to the study of genitourinary malignancies Aims to deliver high-quality research Content: Includes original articles, opinion piece editorials, and invited reviews Covers clinical, basic, and translational research Publication Frequency: Six times a year in electronic format
期刊最新文献
Value of Whole-body Magnetic Resonance Imaging Using the MET-RADS-P Criteria for Assessing the Response to Intensified Androgen Deprivation Therapy in Metastatic Hormone-naïve and Castration-resistant Prostate Cancer. Management of Small Testicular Masses: A Delphi Consensus Study. Reply to Alireza Ghoreifi and Hooman Djaladat's Letter to the Editor re: Yiling Chen, Chenyang Xu, Zezhong Mou, et al. Endoscopic Cryoablation Versus Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma. Eur Urol Oncol. In press. https://doi.org/10.1016/j.euo.2024.04.012. Oncological Outcomes of Active Surveillance versus Surgery or Ablation for Patients with Small Renal Masses: A Systematic Review and Quantitative Analysis. Re: Yiling Chen, Chenyang Xu, Zezhong Mou, et al. Endoscopic Cryoablation Versus Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma. Eur Urol Oncol. In press. https://doi.org/10.1016/j.euo.2024.04.012.
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