DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.

开始日期2026-11-01

申办/合作机构

The University of Chicago

NCT07142551

/ Not yet recruiting临床2期IIT

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Via Modulation of ANdrogen Receptor (the SPIDERMAN Trial)

The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.

开始日期2026-02-20

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

NCT07344779

/ Not yet recruitingN/A

ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

This is an international, prospective, open-label, multicenter, multi-cohort, non-interventional observational study designed to describe the real-world effectiveness and safety of darolutamide in combination with androgen deprivation therapy (ADT), with or without docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study aims to enroll approximately 1,600 male patients (800 per cohort) from multiple countries, primarily in Europe, who have a diagnosis of mHSPC and for whom a decision to treat with darolutamide has been made by the treating physician prior to enrollment. The primary objective is to estimate the proportion of patients achieving undetectable prostate-specific antigen (PSA) levels (<0.2 ng/mL) at 1 year of treatment in each cohort. Secondary objectives include describing patient demographics, clinical characteristics, prior and concomitant treatments, adverse events, and clinical effectiveness measures such as overall survival, time to new treatment, time to castration resistance, and time to PSA progression. Further objectives involve assessing quality of life, reasons for not adding docetaxel, outcomes by patient subgroups (e.g., Gleason score, disease volume, ECOG status), genomic testing results, and hospitalization rates. Data will be collected using electronic case report forms (eCRF) during routine clinical practice, with no additional diagnostic or monitoring procedures required beyond standard care. All patients must provide informed consent prior to participation. The study will comply with applicable regulatory requirements, including IEC/IRB approval in all participating countries. Statistical analyses will be descriptive and exploratory, with interim analyses planned after 200, 400, and 600 patients per cohort have completed at least 12 months of treatment or discontinued therapy. The study is expected to provide valuable insights into the real-world use of darolutamide in mHSPC, supporting clinical decision-making and enhancing understanding of treatment patterns, effectiveness, and safety in diverse patient populations.

开始日期2026-02-17

申办/合作机构

Bayer AG

100 项与达罗他胺相关的临床结果

登录后查看更多信息

100 项与达罗他胺相关的转化医学

登录后查看更多信息

100 项与达罗他胺相关的专利（医药）

登录后查看更多信息

460

项与达罗他胺相关的文献（医药）

2026-02-01·ANTICANCER RESEARCH

Prolonged Castration Prior to Docetaxel Reduces Febrile Neutropenia in Patients With Metastatic Hormone-sensitive Prostate Cancer Receiving Triple Therapy

Article

作者: Kanesaka, Manato ; Higuchi, Kosuke ; Nakamura, Kazuyoshi ; Kurozumi, Akira ; Fukasawa, Satoshi ; Tamura, Takaaki ; Mikami, Kazuo ; Sazuka, Tomokazu ; Sakamoto, Shinichi ; Sato, Hiroaki ; Arai, Takayuki ; Azuma, Haruhito ; Suzuki, Noriyuki ; Takeshita, Nobushige ; Imamura, Yusuke ; Tsujino, Takuya ; Yamada, Yasutaka ; Shirafuji, Tomoki ; Yamamoto, Satoshi ; Sato, Kodai

BACKGROUND/AIM:

Triplet therapy, combining androgen deprivation therapy (ADT), darolutamide, and docetaxel has recently emerged as the standard first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC). Febrile neutropenia (FN) is a major clinical issue not only as a serious infection but also as a cause for early cessation or dose reduction of chemotherapy. However, little is known regarding the predictive factors for the development of FN in patients with mHSPC receiving triplet therapy.

PATIENTS AND METHODS:

This study enrolled 60 patients diagnosed with mHSPC across multiple institutions from 2023 to 2025. We examined clinical characteristics, treatment schedules, adverse events, and oncological outcomes. We focused particularly on the development of FN and used logistic regression analysis to investigate the predictive factors.

RESULTS:

The median age was 72 years old, and 43 patients (73.3%) had high-volume disease at diagnosis. Nine patients (15%) developed FN. Multivariate logistic regression analysis identified older age [≥75, p=0.0161; hazard ratio (HR)=7.49], high-volume disease (p=0.0335), and shorter interval from ADT to docetaxel (<40 days) (p=0.0389; HR=7.86) as independent predictive factors of the development of FN. Notably, prolonged castration period prior to docetaxel (≥40 days) significantly reduced the risk of FN from 23.5% to 3.8% (p=0.0001). Patients who developed FN tended to have shorter castration-resistant prostate cancer progression-free survival (CRPC-PFS) compared to those who did not (p=0.0812; HR=3.2).

CONCLUSION:

Older age and high-volume disease were independent risk factors for FN in patients with mHSPC receiving triplet therapy. A longer interval from ADT initiation to docetaxel (≥40 days) was associated with a significantly lower risk of FN, suggesting that extending the pre-docetaxel castration period is a practical, adjustable scheduling strategy to improve treatment safety. These findings may support treatment selection and proactive prevention of FN.

2026-02-01·INTERNATIONAL JOURNAL OF UROLOGY

Impact of Immunohistochemical PSA and Ki‐67 Expression on Prognosis in Metastatic Castration‐Sensitive Prostate Cancer

Article

作者: Urabe, Fumihiko ; Imai, Yu ; Umemori, Miyaka ; Takahashi, Hiroyuki ; Sato, Shun ; Iwamoto, Yuya ; Kimura, Takahiro ; Tashiro, Kojiro

ABSTRACT:

Background and Objective:

Treatment selection for metastatic castration‐sensitive prostate cancer (mCSPC) remains challenging, as reliable and practical biomarkers predicting response to androgen receptor pathway inhibitor (ARPI)‐based therapy are limited. We evaluated whether prostate‐specific antigen (PSA) and Ki‐67 expression in diagnostic biopsy specimens can predict oncologic outcomes in patients with mCSPC treated with ARPI–androgen deprivation therapy (ADT) doublet therapy, and whether these biomarkers can guide optimal treatment selection.

Methods:

This retrospective multicenter study included 58 patients with mCSPC who received ARPI–ADT doublet therapy between 2018 and 2024. Immunohistochemical staining for PSA and Ki‐67 was performed on diagnostic biopsy specimens. Receiver operating characteristic curve analyses were used to determine optimal cutoff values for predicting progression to castration‐resistant prostate cancer (CRPC). Survival outcomes were analyzed using the Kaplan–Meier method and Cox proportional hazards models. Exploratory analyses included patients treated with triplet therapy (ADT + docetaxel + darolutamide) or upfront docetaxel.

Results:

Low PSA expression, high Ki‐67 expression, and a bone metastasis extent of disease (EOD) score ≥ 3 were independently associated with shorter CRPC‐free survival (CRPC‐FS). Stratification by risk factors (0, 1, or 2) showed a stepwise decline in CRPC‐FS. In exploratory analyses, triplet therapy achieved the longest CRPC‐FS and progression‐free survival 2 among high‐risk patients, whereas no significant differences among treatment modalities were observed in the low‐risk group.

Conclusion:

Immunohistochemical PSA and Ki‐67 expression provide practical prognostic information for patients with metastatic castration‐sensitive prostate cancer. Combined assessment with EOD ≥ 3 identifies a high‐risk subgroup with unfavorable clinical outcomes.

2026-01-01·European Urology Open Science

Integration of Darolutamide in the Treatment Landscape for Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis of Efficacy and Safety

Article

作者: Bektic, Jasmin ; Kafka, Mona ; Horninger, Wolfgang ; Artamonova, Nastasiia ; Giannini, Giulia ; Ladurner, Michael ; Melchior, Felix ; Koett, Magdalena ; Heidegger, Isabel ; Keller, Felix ; Neuwirt, Hannes

Background and objective:

Recent advances have led to the introduction of multiple combination treatments for metastatic hormone-sensitive prostate cancer (mHSPC), but their comparative efficacy and toxicity remain uncertain owing to the absence of head-to-head comparisons. We evaluated the efficacy and safety profile of darolutamide plus androgen deprivation therapy (ADT) in comparison to other treatments.

Methods:

A systematic search was conducted in the Cochrane Library up to September 30, 2024 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Hazard ratios (HRs) and confidence intervals (CIs) for progression-free survival (PFS) and overall survival (OS) were extracted. Odds ratios (ORs) for treatment-emergent adverse events (TEAEs) were calculated from the events reported.

Key findings and limitations:

Eleven trials involving 11 389 patients were included. Darolutamide triplet therapy was associated with the highest overall PFS (HR 0.24, 95% CI 0.20-0.29) and OS (HR 0.54, 95% CI 0.44-0.66). The highest PFS in low-volume disease was observed with enzalutamide (HR 0.29, 95% CI 0.21-0.38) and darolutamide (HR 0.30, 95% CI 0.15-0.60). All androgen receptor pathway inhibitors (ARPIs) had higher toxicity than ADT, except for darolutamide (OR 0.99, 95% CI 0.71-1.39). In comparison to darolutamide, enzalutamide (OR 2.03, 95% CI 1.08-3.80) and abiraterone (OR 3.18, 95% CI 1.74-5.80) were associated with higher risk of hypertension. Enzalutamide was associated with a higher risk of fatigue (OR 3.22, 95% CI 1.28-8.07). Limited direct comparisons between treatments may affect our conclusions regarding relative efficacy.

Conclusions and clinical implications:

Our findings support the role of darolutamide as an effective and well-tolerated ARPI for mHSPC, particularly in low-volume metachronous disease and comorbidity-limited cases. These results may assist clinicians in planning personalized treatment strategies that balance efficacy and safety.

Patient summary:

We compared different medical treatment options for metastatic hormone-sensitive prostate cancer, with a special focus on a drug called darolutamide. Darolutamide is well tolerated and is effective, particularly in patients with a low volume of metastasis and patients with other health conditions that may limit their treatment options.

491

项与达罗他胺相关的新闻（医药）

2026-02-04

·GBIHealth

拜耳、阿斯利康/第一三共、艾伯维新药获批

药械追踪 No.1 / 拜耳达罗他胺在中国获批晚期前列腺癌新适应证 2026年2月3日，拜耳（OTCMKTS：BAYRY）宣布，旗下诺倍戈（达罗他胺）获国家药监局批准新适应证，联合雄激素剥夺疗法（ADT）用于治疗转移性激素敏感性前列腺癌（mHSPC）患者。此次获批基于关键性Ⅲ期 ARANOTE 试验的积极结果。研究显示，在 mHSPC 患者中，达罗他胺联合 ADT 与安慰剂联合 ADT 相比，显著降低了 46% 的影像学进展或死亡风险（HR 0.54；P<0.0001）。此外，达罗他胺联合 ADT 的耐受性良好，因不良事件导致的停药率低于对照组。达罗他胺是一款口服雄激素受体抑制剂，其分子结构独特，具有高AR亲和力，从而抑制受体功能和前列腺癌细胞的生长。2021年2月3日，达罗他胺首次在中国获批用于治疗有高危转移风险的非转移性去势抵抗性前列腺癌（nmCRPC），2023年3月获批联合多西他赛治疗转移性激素敏感性前列腺癌（mHSPC）成年患者。 ->点击文末阅读原文，解锁完整双语新闻 No.2 / 阿斯利康/第一三共德达博妥单抗获美国FDA优先审评 2026年2月3日，阿斯利康（LSE/STO: AZN）和第一三共（TSE: 4568）宣布，美国FDA已受理Datroway (德达博妥单抗) 的补充生物制品许可申请（sBLA）并授予其优先审评（Priority Review）资格。该申请用于治疗不适合接受 PD-1/PD-L1 抑制剂疗法的不堪切除或转移性三阴性乳腺癌（TNBC）成人患者。 Datroway是一种靶向TROP2的抗体偶联药物（ADC），由第一三共发现，并由阿斯利康与第一三共联合开发和商业化。截至目前，Datroway已获批两项适应证：用于治疗既往接受过靶向疗法和含铂化疗的EGFR突变局部晚期或转移性NSCLC成人患者（基于ORR和DoR的加速获批）；治疗既往接受过内分泌疗法和化疗的HR阳性、HER2阴性（包括IHC0，1+或2+/ISH-）转移性乳腺癌成人患者。 ->点击文末阅读原文，解锁完整双语新闻 No.3 / 艾伯维在美欧提交乌帕替尼新适应证，用于治疗白癜风 2026年2月3日，艾伯维（NYSE：ABBV）宣布，已向美国FDA和欧洲EMA提交了乌帕替尼（upadacitinib，商品名：RINVOQ；15 mg，每日一次）的新适应证上市申请，用于治疗患有非节段型白癜风（NSV）的成人及青少年患者。乌帕替尼是艾伯维开发的JAK抑制剂，最早于2019年在美国获批，2022年进入中国市场。乌帕替尼已在中国获批多项免疫炎性疾病适应证，涵盖特应性皮炎、类风湿关节炎、银屑病关节炎、溃疡性结肠炎、克罗恩病、强直性脊柱炎、放射学阴性中轴型脊柱关节炎、巨细胞动脉炎。目前，乌帕替尼正在进行多项免疫介导性炎症疾病的Ⅲ期临床研究，包括：斑秃、化脓性汗腺炎、大动脉炎、系统性红斑狼疮以及白癜风。 ->点击文末阅读原文，解锁完整双语新闻企业动态 No.1 /济川药业9000万元获康方生物伊喜宁中国大陆商业化权益 2026年2月4日，康方生物（9926.HK）宣布与济川药业签署《独占性商业化权益协议》。根据协议，在合作期限内，康方生物将旗下已获批上市产品伊喜宁（伊努西单抗注射液）的中国大陆独家商业化权益授予济川药业。康方生物将获得由济川药业支付的人民币8000万元（含税）授权费，以及最高不超过1000万元（含税）的里程碑付款；济川药业将负责伊喜宁在中国大陆的商业化推广和销售。伊喜宁是康方生物自主开发创新PCSK9单克隆抗体，通过特异性结合PCSK9并阻断其与LDL-R的相互作用，恢复LDL-R的表达水平以提升对血浆中LDL-C的清除能力。伊喜宁于2024年9月在中国获批上市，用于治疗原发型高胆固醇血症和混合型高脂血症，包括杂合子家族性高胆固醇血症(HeFH)及同时患有动脉粥样硬化性心血管疾病的高胆固醇血症。目前，伊喜宁已被纳入最新版国家医保目录。 ->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

2026-02-04

·T1医药咨询

药讯2.4｜4000万美元！先声药业获艾伯维里程碑付款；1.4亿美元！阿诺医药完成私募融资

T1药讯 | 前沿新闻，一触即达 NEWS 新闻早知道小报速递 4000万美元！先声药业收到艾伯维里程碑付款 1.4亿美元！阿诺医药完成私募融资 9000万元！济川药业获康方生物PCSK9单抗商业化权益 4000万美元！拓胜医药完成天使轮融资药明生物与Vertex达成合作中晟全肽与礼来达成多肽药物全球研发合作拜耳达罗他胺在华获批新适应症诺华司库奇尤单抗在华获批新适应症和铂医药发布正面盈利预告诺和诺德发布2026年业绩预警印度宣布投资11亿美元发展生物制药 4000万美元！先声药业收到艾伯维里程碑付款 2月3日，先声药业宣布收到艾伯维支付的4000万美元里程碑付款，双方就GPRC5D/BCMA/CD3三特异性抗体SIM0500达成的合作总额最高可达10.55亿美元。该药由先声药业自有T细胞衔接器平台开发，通过低亲和力CD3抗体与双肿瘤靶向机制增强抗肿瘤活性。 1.4亿美元！阿诺医药完成私募融资 2月3日，纳斯达克上市临床阶段生物技术公司阿诺医药宣布完成1.4亿美元私募融资，由Cormorant Asset Management和Columbia Threadneedle Investments共同领投。融资将用于推进其RAS靶向管线，包括pan-RAS抑制剂AN9025（2026年一季度首例患者入组）及CEACAM5靶向ADC药物AN4035（2026年中申报IND）。公司创始人路杨称此次融资印证了投资者对其RAS平台价值的认可。 9000万元！济川药业获康方生物PCSK9单抗商业化权益 2月3日，济川药业宣布获得康方生物PCSK9单抗伊努西单抗注射液中国大陆独家商业化权益，首付款8000万元，里程碑款不超过1000万元。该药于2024年9月获批用于高胆固醇血症，已纳入2025年国家医保目录。济川药业将依托渠道优势推动产品市场覆盖。 4000万美元！拓胜医药完成天使轮融资 2月3日，由前赛诺菲全球研发负责人刘勇军教授创立的拓胜医药宣布完成4000万美元天使轮融资，由齐济投资与嘉道资本领投。融资将用于推进多靶点布局的第三代抗体偶联药物研发，聚焦肿瘤领域创新疗法。药明生物与Vertex达成合作 2月3日，药明生物宣布与Vertex Pharmaceuticals签署授权协议，后者获得一款针对B细胞介导自身免疫疾病的三特异性T细胞衔接器全球权益。药明生物将获得首付款、里程碑款及销售分成，并为其提供一体化研发服务。药明生物CEO陈智胜表示，此次合作彰显了其CRDMO模式与技术平台价值。中晟全肽与礼来达成多肽药物全球研发合作 2月3日，湖南中晟全肽宣布与礼来制药达成全球研发合作与许可协议，双方将基于中晟全肽的多肽库及发现技术平台共同开发新型多肽候选药物。中晟全肽负责筛选活性分子，礼来负责后续临床开发与商业化。中晟全肽将获得首付款及里程碑付款，并有资格获得销售分层特许权使用费。拜耳达罗他胺在华获批新适应症 2月3日，拜耳宣布其口服雄激素受体抑制剂达罗他胺（商品名：Nubeqa）获中国国家药监局批准新适应症，联合雄激素剥夺疗法用于治疗转移性激素敏感性前列腺癌（mHSPC）。这是该药在华获批的第三项适应症。达罗他胺由拜耳与芬兰Orion公司联合开发，2024年全球销售额达16.41亿美元。诺华司库奇尤单抗在华获批新适应症 2月3日，诺华宣布其IL-17A抑制剂司库奇尤单抗（商品名：可善挺）获NMPA批准新适应症，用于治疗对NSAIDs应答不佳的活动性放射学阴性中轴型脊柱关节炎成人患者。III期PREVENT研究显示，治疗组16周ASAS40应答率达40%，显著优于安慰剂组。此为该药在华获批的第六项适应症。和铂医药发布正面盈利预告，2025年利润最高达9500万美元 2月4日，和铂医药发布公告称，预计2025年盈利介于8800万至9500万美元，较2024年270万美元大幅增长。利润增长主要源于与阿斯利康、百时美施贵宝等企业的平台合作收入，以及诺纳生物技术授权与里程碑付款。诺和诺德发布2026年业绩预警，股价单日跌幅创十年之最 2月3日，诺和诺德发布2026年销售与利润增长预警，预计营收增速将放缓至中个位数百分比，营业利润增幅可能降至低个位数。受此影响，公司股价当日暴跌18%，市值单日蒸发约450亿美元，创2014年以来最大单日跌幅。公司解释称，业绩压力主要来自美国市场GLP-1药物定价竞争加剧、医保政策调整以及仿制药对旧款胰岛素的冲击。印度宣布投资11亿美元发展生物制药，目标夺取全球5%市场份额 2月3日，印度政府宣布未来五年投入1000亿卢比（约11亿美元）推动生物制药发展，计划新建3所国家级研究所并升级7所现有机构，同时建立超1000个临床试验基地。该战略旨在将印度从传统仿制药生产转向生物药、基因治疗等前沿领域，减少进口依赖并提升全球供应链竞争力。信息来源：网络 — END — 关于仕揽 Talent One 仕揽（Talent One）是一家专注于生命科学领域中高端人才招聘及一站式人力资源整体解决方案服务商，致力于成为创业者、科学家和高管们值得信赖的伙伴。我们的团队成员充满激情和经验丰富，曾成功为国内多家知名药企寻聘C-level高管和搭建创始管理团队，擅长为制药公司输入药物早期发现、临床前研究、临床开发、药政事务、CMC开发、生产质量、BD/投资、市场销售等方向的高品质、高价值人才。未来，仕揽（T1）将坚定以客户为中心，持续为客户创造价值，为医疗大健康行业贡献一份力量招聘

引进/卖出抗体药物偶联物申请上市

2026-02-04

·adalvo.com

Innovating to fight cancer

On World Cancer Day, we are proud to renew our commitment to the people behind every cancer diagnosis – individuals with unique circumstances, treatment needs, and hopes for the future. The current World Cancer Day theme, United by Unique, reminds us that effective cancer care begins with listening. Adalvo’s approach is about responding to real patient needs: identifying where access gaps exist and working to bring differentiated therapies to the people who need them, quickly and reliably. Our oncology portfolio includes 34 therapies, with six new treatments added in the past year alone: Osimertinib for EGFR-mutated lung cancer Alectinib for ALK-positive lung cancer Abemaciclib for HR-positive breast cancer Acalabrutinib for blood cancers including chronic lymphocytic leukaemia Darolutamide for advanced prostate cancer Trifluridine/Tipiracil for metastatic colorectal cancer. Each patient's journey is different, which is why we're developing value-added medicines, like our Lenvatinib oral solution. It’s designed to improve treatment adherence and offer flexible dosing for patients who struggle to swallow capsules. Our ‘asset-light’ model means we can move with agility, focusing our resources where they matter most: getting high-quality treatments to patients faster. World Cancer Day reminds us that behind every therapy launch, every regulatory milestone, every partnership, there are people waiting – and that sense of urgency drives everything we do. For more information about Adalvo's oncology portfolio, please contact one of the team today.

ASCO会议

100 项与达罗他胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11045	达罗他胺	L02BB06	DB12941

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
激素依赖性前列腺癌	欧盟	Bayer AG	2023-03-20
激素依赖性前列腺癌	冰岛	Bayer AG	2023-03-20
激素依赖性前列腺癌	列支敦士登	Bayer AG	2023-03-20
激素依赖性前列腺癌	挪威	Bayer AG	2023-03-20
去势敏感前列腺癌	中国	Bayer HealthCare Pharmaceuticals, Inc.	2023-03-16
转移性前列腺癌	日本	Bayer AG	2023-02-24
转移性去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2022-08-05
前列腺癌	巴西	Bayer AG	2020-01-01
去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2019-07-30

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
局限性前列腺癌	临床3期	法国	Bayer AG	2025-04-10
局限性前列腺癌	临床3期	马提尼克	Bayer AG	2025-04-10
复发性前列腺癌	临床3期	美国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	中国	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	日本	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	澳大利亚	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	奥地利	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	比利时	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	巴西	Bayer AG	2023-04-03
复发性前列腺癌	临床3期	加拿大	Bayer AG	2023-04-03

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02200614 (ARAMIS, Pubmed \| Cancer Med)	临床3期	去势抵抗性前列腺癌	1,509	Darolutamide + ADT	廠願網鹹艱獵遞糧衊淵(襯積窪鏇網餘糧範網膚): HR = 0.36 (95.0% CI, 0.26 ~ 0.48) 更多	积极	2026-01-01
				Placebo + ADT
ChiCTR2500096436 (DAPLOM, ESMO_ASIA2025)	临床2期	去势敏感前列腺癌	60	Darolutamide + ADT + prostate arterial docetaxel infusion	衊積觸餘顧蓋夢鏇選鏇(齋獵淵廠鑰鏇鏇鑰築憲) = 夢夢範餘膚觸餘糧網鑰鬱鹹顧艱範遞膚築鹹願 (願憲鬱鏇壓衊顧選鏇齋 )	积极	2025-12-05
ESMO_ASIA2025	N/A	激素依赖性前列腺癌	25	Darolutamide + Docetaxel + ADT	繭鏇齋壓窪鏇壓選糧廠(範夢憲構壓艱範顧積鏇) = 壓鏇襯蓋鬱鹹糧襯築鏇鹽範顧淵範餘憲艱簾淵 (選襯構積鹹遞簾壓觸製 ) 更多	积极	2025-12-05
ESMO_ASIA2025	N/A	激素依赖性前列腺癌	8	Darolutamide + Trans-arterial chemoperfusion by Docetaxel + ADT	糧範構簾鑰淵製繭膚夢(願製鬱艱淵網憲製壓襯) = 蓋醖範鏇夢窪積願餘淵鏇鑰願衊餘夢繭鏇憲襯 (構積衊築醖製憲鬱願餘 ) 更多	积极	2025-12-05
ARAMIS (ESMO_ASIA2025)	临床3期	去势抵抗性前列腺癌	76	Darolutamide + androgen-deprivation therapy	築糧膚願膚壓鏇範淵觸(觸鹹壓鏇淵憲簾艱齋鑰) = 艱簾鏇鑰淵艱鏇艱鏇壓醖簾網鬱製選鏇鹽鹽膚 (繭積鬱襯顧淵選選憲願 ) 更多	积极	2025-12-05
NCT05794906 (ARASTEP, Pubmed \| Future Oncol)	临床3期	非转移性前列腺癌	970	Darolutamide + ADT	鬱獵遞窪網築壓糧遞範(製壓餘願廠醖蓋鹹餘簾) = 觸窪願夢淵獵鑰鹹鏇夢鑰鏇膚鏇獵鬱繭齋膚壓 (窪壓夢壓繭遞餘蓋繭願 ) 更多	积极	2025-11-14
				Placebo + ADT	鬱獵遞窪網築壓糧遞範(製壓餘願廠醖蓋鹹餘簾) = 範憲醖衊糧製憲糧膚簾鑰鏇膚鏇獵鬱繭齋膚壓 (窪壓夢壓繭遞餘蓋繭願 ) 更多
ESMO2025	N/A	激素依赖性前列腺癌	242	Darolutamide+ADT+DOC (DAR)	範夢網繭壓憲繭積窪鏇(齋蓋鏇觸網顧選選顧醖) = 觸齋鬱襯鏇醖簾願顧憲築鹹鑰憲願願膚廠簾窪 (糧糧網襯襯選鏇壓鑰選, 51.0 ~ 72.9) 更多	积极	2025-10-17
				Abiraterone+ADT+DOC (ABI)	範夢網繭壓憲繭積窪鏇(齋蓋鏇觸網顧選選顧醖) = 範餘網繭鏇憲獵範醖壓築鹹鑰憲願願膚廠簾窪 (糧糧網襯襯選鏇壓鑰選, 32.0 ~ 63.0) 更多
ESMO2025	N/A	去势敏感前列腺癌	455	Darolutamide + Docetaxel	餘鑰蓋製觸鏇獵齋鏇獵(餘艱鬱選積簾鬱襯顧構) = 簾壓鏇鹹繭簾壓廠築齋鹽顧觸觸憲遞構顧蓋壓 (艱網鬱鹽齋窪鹹膚構觸 )	积极	2025-10-17
				Apalutamide	餘鑰蓋製觸鏇獵齋鏇獵(餘艱鬱選積簾鬱襯顧構) = 醖選夢網獵憲獵獵鑰築鹽顧觸觸憲遞構顧蓋壓 (艱網鬱鹽齋窪鹹膚構觸 )
ESMO2025	N/A	激素依赖性前列腺癌	1,189	ADT + Docetaxel + Darolutamide	遞蓋簾鑰鹹壓蓋獵構願(夢廠鬱壓鹽構憲鹹憲願): HR = 0.42 (95.0% CI, 0.21 ~ 0.82)	积极	2025-10-17
				ADT + Docetaxel
ARAMIS (ESMO2025)	临床3期	去势抵抗性前列腺癌	4,117	Darolutamide + ADT	鏇製糧鹹憲蓋廠構積製(膚簾觸繭願夢願壓壓齋) = 窪繭範夢糧醖鏇鏇繭鹽廠鏇鏇遞蓋鬱製鑰積餘 (鏇製壓膚鏇簾窪簾夢壓 )	积极	2025-10-17
				Apalutamide + ADT	鏇製糧鹹憲蓋廠構積製(膚簾觸繭願夢願壓壓齋) = 膚願窪鬱築糧膚獵廠範廠鏇鏇遞蓋鬱製鑰積餘 (鏇製壓膚鏇簾窪簾夢壓 )