Randomized, Double-blind, Double-masked, Parallel-group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia.

The clinical trial to evaluate the fixed-dose combination (N0728), with the aim of providing the Brazilian market with an alternative, potentially effective, safe and convenient therapeutic approach for the treatment of Lower Urinary Tract Symptoms (LUTS) in men with Benign Prostatic Hyperplasia (BPH). The fixed-dose combination has synergistic action between drugs from different classes and offers significant potential advantages, such as better adherence to treatment. The trial will assess the non-inferiority in efficacy and safety of the proposed fixed-dose combination compared to alpha-adrenergic antagonists.

开始日期2026-11-30

申办/合作机构

Eurofarma Laboratórios SA

NCT04993508 / Not yet recruitingN/AIIT

Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer with Combination of PSA/DRE and Multi Parametric Magnetic Resonance Imaging

This randomized prospective multi center study is designed to confirm a new diagnostic pathway in primary diagnosis of clinically significant prostate cancer by combination of serum levels of prostate specific antigen (PSA), digitorectal examination (DRE), and multiparametric magnetic resonance imaging (mpMRI). Men at the age of 50 to 75 with an elevated PSA (>= 4 ng/ml) and /or suspicious DRE receive an upfront multi parametric MRI. Only men with MRI results suspicious of clinically significant prostate cancer will be biopsied. Those will be randomized into arm A and arm B. Arm A undergoes only targeted MRI/US fusion-guided biopsies (= TB with a maximum of 3 targets and 2 cores per target). Arm B receives systematic biopsies (= SB with 12 biopsy cores) and TB. Men with normal mpMRI will be observed in a structured manner but will not be biopsied (arms C and D). The primary objective comprises the demonstration of non-inferiority of the detection clinically significant prostate cancer (ISUP grade group 1) of TB (arm A) compared to TB+SB (arm B). Overall, our study aims to improve patient care by reducing the number of patients biopsied, by reducing the number of biopsy cores per patient, and by lowering the risk of overdiagnosis of indolent prostate cancer. The results of this study will directly influence clinical practice, will have a positive impact on patients' lives, and will lower the financial burden due to reduced overdiagnosis and over treatment.

开始日期2026-07-01

申办/合作机构

Heinrich-Heine-Universität Düsseldorf

[+6]

NCT06215508 / RecruitingN/AIIT

Prostate Cancer Geriatric Assessment and Technology Evaluation (ProsGATE) Study

By doing this study, doctors hope to learn more about factors that contribute to frailty (a condition where older adults feel weak, get tired easily, and struggle more with everyday activities) and serious side effects among men over the age of 65 who will receive androgen deprivation therapy (also called "hormone therapy") for prostate cancer that has spread to other parts of their body. Participation in this research will last about 5 years. For the first year, participants will have 5 study visits where they have give blood samples, answer survey questions, and use a wearable device. After study visits are complete, there is a 4-year follow-up period. Research team will check regular doctor visits and look at participants' medical records.

开始日期2026-04-01

申办/合作机构

The University of Chicago

100 项与前列腺疾病相关的临床结果

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100 项与前列腺疾病相关的转化医学

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0 项与前列腺疾病相关的专利（医药）

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187,719

项与前列腺疾病相关的文献（医药）

2025-12-01·Current Urology Reports

Recent Advancements in Prostate Catheters and Stents for Management of Benign Prostatic Hyperplasia

Review

作者: Chughtai, Bilal ; Bhojani, Naeem ; Codelia-Anjum, Alia ; Winograd, Joshua ; Elterman, Dean ; Lama, John ; Zorn, Kevin C

PURPOSE OF REVIEWThe prevalence of benign prostatic hyperplasia (BPH) is rising, however, current treatment options present severe complications and limit patient's quality of life. Accordingly, advancements in prostatic catheter and stent designs for use in treating lower urinary tract symptoms (LUTS) in BPH patients have largely expanded in the past five years and we aim to provide an exhaustive summary of recent outcomes.RECENT FINDINGSThe dual dilation and paxlitaxel eluting Optilume BPH Catheter System enhances promise in catheter-based treatments, providing the longest sustained increase in max urinary flow rate and decrease in post-void residual volume compared to alternative MISTs. Additionally, use of iTiND, along with recent advancements in temporary (EXIME, Prodeon Urocross) and permanent (Zenflow Spring, Butterfly, and ClearRing) stent designs, have demonstrated rapid, lasting, and low-cost LUTS relief with sustained sexual function. Minimally invasive solutions that offer in-office treatment, rapid symptom relief, shorter recovery times, and preservation of sexual function hold great promise in improving outcomes in managing BPH patients with LUTS.

2025-04-01·DEN Open

A diminutive perivascular epithelioid cell tumor in the colon

作者: Sano, Yasushi ; Sano, Wataru ; Iwatate, Mineo ; Fujimori, Takahiro ; Hirata, Daizen ; Fujita, Mikio ; Sugimura, Naoki ; Hattori, Santa

AbstractPerivascular epithelioid cell tumor (PEComa) is a rare mesenchymal tumor. Some papers have reported that colonoscopy could be used to treat PEComa with a predominantly pedunculated polyp, whereas surgical intervention is often required for cases with submucosal‐type tumors. These findings suggest that the morphology of PEComa changes dramatically with disease progression. Because of the rapid progression of PEComa, endoscopic treatment remains challenging, and early‐stage PEComa morphology is not well understood. A 64‐year‐old man presented to our hospital for a follow‐up colonoscopy after undergoing multiple polypectomies. He had a medical history of colorectal adenoma and prostate cancer. A 4‐mm pale blue elevated but not pedunculated lesion was observed in the transverse colon, an area where he had not had polyps previously. Since no epithelial change was observed, the presence of a submucosal tumor, such as a gastrointestinal stromal tumor, was suspected. Cold snare polypectomy was performed, and the lesion was completely resected. Histological evaluation using hematoxylin and eosin staining identified that the submucosal tumor included thickened vascular walls and adipose tissue. Although fragmented due to significant degeneration, spindle‐shaped cells staining positive for smooth muscle actin were observed within and surrounding the unstructured hyalinized tissue with calcifications. Based on these findings, the lesion was diagnosed as angiomyolipoma, a subtype of PEComa. Complete resection was confirmed by histopathology. To our knowledge, this PEComa is the smallest of any PEComa reported in the literature. Our finding provides valuable insights into the very early stage of colorectal PEComas.

2025-02-01·Archives of Medical Research

GNLY as a novel cis-eQTL and cis-pQTL mediated susceptibility gene in suppressing prostatitis. Mendelian randomization study

Article

作者: Chen, Guihua ; Wang, Xiang ; Zhang, Dongliang ; Zhou, Jianhua ; Wang, Yi ; Ji, Hao

BACKGROUNDProstatitis is characterized by high prevalence, low cure rates, and frequent recurrences, and remains one of the most clinically challenging problems. Hence, in this article, we first integrated Mendelian randomization (MR) with expression quantitative trait loci (eQTL) and protein quantitative trait loci (pQTL) data to identify novel therapeutic targets and their potential metabolic mechanisms for prostatitis.METHODSProstatitis-related genetic data, eQTLs, pQTLs, and 1400 metabolites were downloaded from online databases. MR, or summary data-based MR (SMR) analyses were applied to assess the potential causal relationships between exposures and predicted outcomes. Sensitivity analysis was conducted using pleiotropy, heterogeneity, and leave-one-out analysis to evaluate the robustness of our results.RESULTSBased on our results, we first identified and validated GNLY as a novel cis-eQTL and cis-pQTL-mediated susceptibility gene for reducing prostatitis risk in five independent datasets (one discovery dataset and four validation datasets) (all p <0.05). Meanwhile, we also found that the GNLY eQTL could increase the metabolite of sphingomyelin level (d18:0/20:0, d16:0/22:0) risks (p <0.05), and the metabolite of sphingomyelin level (d18:0/20:0, d16:0/22:0) could reduce the risk of prostatitis (p <0.05). According to the above-mentioned relationships, we finally revealed the potential metabolic mechanism of GNLY eQTL in suppressing prostatitis via regulating the metabolite of sphingomyelin level (d18:0/20:0, d16:0/22:0).CONCLUSIONSWe successfully identified GNLY as a novel cis-eQTL and cis-pQTL-mediated susceptibility gene in suppressing prostatitis and its potential metabolic mechanism via regulating sphingomyelin (d18:0/20:0, d16:0/22:0) levels, providing a novel therapeutic target and paving the way for future GNLY-related studies in prostatitis.

7,705

项与前列腺疾病相关的新闻（医药）

2024-10-31

·PipelineReview

Alterome Therapeutics Announces First Patient Dosed in Phase 1 Study of ALTA2618 in AKT1 E17K-mutant solid tumors (AKTive-001)

AKTive-001 is a Phase 1/1b study of ALTA2618 in adults with AKT1 E17K-mutant solid tumors ALTA2618 is the first clinical mutant-selective inhibitor of AKT SAN DIEGO, CA, USA I October 30, 2024 I Alterome Therapeutics, Inc. , a clinical stage biopharmaceutical company pioneering the development of next generation, small molecule targeted therapies for the treatment of cancer, today announced the dosing of the first patient in AKTive-001, a Phase 1/1b trial of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors. ALTA2618 is the first mutant-selective allosteric inhibitor of AKT1 E17K and is designed to avoid on-target toxicities associated with inhibition of AKT family kinases. AKT1 E17K is a clinically validated oncogene that drives ~5% of breast cancer, particularly hormone positive disease, and 1-2% of all cancer, including endometrial (~3%) and prostate (~2%) cancers. “Dosing the first patient in the AKTive-001 trial marks a significant milestone for Alterome as we advance the first program from our mutation-selective and isoform-selective discovery pipeline to the clinic,” said Eric Murphy, Ph.D., co-founder and CEO of Alterome Therapeutics. “ALTA2618 was designed to selectively target the AKT1 E17K mutation by pioneering a novel covalent approach to capture the lysine mutation. From concept to clinic, ALTA2618 illustrates the relentless execution of our team and dedication to developing novel mutation-selective therapies that will improve outcomes for patients with cancer.” AKTive-001 is a Phase 1/1b, open-label, dose escalation and multiple expansion cohort study evaluating ALTA2618 as an oral monotherapy. The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of ALTA2618 in patients aged 18 years or above with AKT1 E17K-mutated advanced unresectable or metastatic solid tumors (NCT06533059). Additional clinical sites across Europe, Asia and Australia will initiate enrollment over the next year. About Alterome Therapeutics, Inc. Alterome Therapeutics, Inc. is a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by an expert team of precision oncology R&D leaders with a history of developing marketed oncology small molecule drugs. For more information, visit www.alterome.com . Follow us on LinkedIn and Twitter . SOURCE: Alterome Therapeutic

临床1期

2024-10-31

·医药笔记

安进：第2款实体瘤CD3双抗，Xaluritamig将启动前列腺癌三期临床

▎Armstrong 2024年10月30日，安进发布三季度财报，介绍了研发管线的最新进展，肿瘤业务板块中重点提到STEAP1/CD3双抗Xaluritamig将在本季度启动紫杉醇后线的前列腺癌三期临床试验。 Xaluritamig采用Xencor的XmAb 2+1技术设计，目前处于一期临床阶段，意味着安进将直接推进到三期临床。 Xencor还有其他多款实体瘤CD3双抗在推进中，覆盖靶点包括ENPP3、Claudin6、B7H3等，均采用XmAb 2+1技术。今年AACR会议上，安进披露了Xaluritamig的一期临床数据，PSA和RECIST评估疗效数据如下，PSA50为49%，PSA90为28%。以RECIST评估，高剂量组ORR为41%，DCR为79%。总结作为最老牌的biotech，安进研发管线中还有多哥潜在爆款产品，除了前述两款实体瘤CD3双抗，还有自免领域的OX40抗体Rocatinlimab，代谢领域的GIPR抗体融合GLP-1分子MariTide等。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

AACR会议临床3期财报抗体药物偶联物

2024-10-31

·药明康德

2024诺奖得主联合创建，新锐开发全新治疗模式；1.15亿美元助力潜在“first-in-class”小分子疗法获得概念验证……

▎药明康德内容团队编辑 David Baker博士联合创建，新锐完成2000万美元种子轮融资 Archon Biosciences今日宣布走出隐匿模式，并完成2000万美元种子轮融资。该公司的技术平台利用了人工智能（AI）驱动的计算蛋白设计方面的进展。此项技术因在创建具有特定功能的新蛋白方面的能力而被授予2024年诺贝尔化学奖。诺奖得主，华盛顿大学的David Baker博士是该公司的联合创始人之一。 Archon Biosciences致力于设计一种称为抗体笼（antibody cage，AbC）的全新生物制品类型。它由抗体和一组在大自然中不存在的AI生成蛋白结构域组合而成。对AbC结构的精准控制可以调节其在体内的分布方式以及与细胞靶点的高特异性和高效性相互作用。 Archon将生成式蛋白设计直接应用于药物开发，不仅设计，而且迅速制造出新分子实体以供临床前研究。AbC的设计结合了现成的抗体和计算设计的结合蛋白，这些蛋白通过自组装，构成精确的几何纳米结构。由于其独特的几何形状，AbC在体内的行为和与靶点的相互作用不同于传统的生物制品，能够更好地控制如靶点结合和生物分布等功能特性。 1.15亿美元助力潜在“first-in-class”小分子疗法获得临床概念验证 Axonis Therapeutics今日宣布成功完成超额认购的1.15亿美元A轮融资。获得资金将用于推进其主要候选药物AXN-027的临床概念验证。AXN-027是一种潜在“first-in-class”的口服小分子药物，旨在增强KCC2的功能。KCC2是中枢神经系统中的主要氯离子转运蛋白，对抑制性神经信号传递至关重要，AXN-027的适应症包括癫痫和疼痛。本轮融资还将支持新一代靶向KCC2化合物的开发，覆盖癫痫、疼痛及包括精神类和神经发育类疾病在内的其他适应症。开发下一代核药，新锐完成7650万美元A轮融资 Blue Earth Therapeutics今日宣布完成7650万美元A轮融资。获得的资金将帮助该公司进一步推进其处于临床阶段的前列腺特异性膜抗原（PSMA）靶向放射性配体疗法的开发。该公司的放射性配体分子由四个不同的结构域组成。第一个结构域是靶向PSMA的配体，连接有两个可标记的结构域，这些结构域可以用治疗性同位素如177Lu或225Ac标记成为放射性配体疗法。所有这些成分通过可调节的连接子相连，用于调控疗法的重要药代动力学特性。目前该公司基于177Lu的放射性配体疗法已经进入1期临床试验，用于治疗前列腺癌患者。针对中枢神经系统疾病，新锐完成4500万美元融资 Leal Therapeutics今日宣布完成4500万美元融资。获得资金将用于推进该公司针对中枢神经系统疾病患者的反义寡核苷酸（ASO）和小分子疗法产品管线。Leal的主要在研项目包括LTX-002，一款治疗遗传性或散发性肌萎缩侧索硬化（ALS）患者的ASO疗法，以及LTX-001，一款针对精神分裂症患者的小分子药物。该公司计划在2024年底前提交LTX-002和LTX-001的IND申请，并在2025年初启动首次人体临床试验。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Archon Biosciences Emerges from Stealth to Advance a New Class of Biologic Invented in Nobel Prize-Winning Computational Protein Design Lab. Retrieved October 30, 2024, from https://www.archon.bio/news/archon-biosciences-emerges-from-stealth-to-advance-a-new-class-of-biologic-invented-in-nobel-prize-winning-computational-protein-design-lab [2] Leal Therapeutics Announces $45 Million Financing to Progress Novel Therapies for Patients with Major Neurodegenerative and Neuropsychiatric Disorders. Retrieved October 30, 2024, from https://www.prnewswire.com/news-releases/leal-therapeutics-announces-45-million-financing-to-progress-novel-therapies-for-patients-with-major-neurodegenerative-and-neuropsychiatric-disorders-302290936.html [3] Blue Earth Therapeutics Ltd announces completion of $76.5M Series A financing to accelerate development of next generation targeted radioligand therapies. Retrieved October 30, 2024, from https://www.prnewswire.com/news-releases/blue-earth-therapeutics-ltd-announces-completion-of-76-5m-series-a-financing-to-accelerate-development-of-next-generation-targeted-radioligand-therapies-302290606.html [4] Axonis Therapeutics Announces $115 Million Series A Financing. Retrieved October 30, 2024, from https://www.prnewswire.com/news-releases/axonis-therapeutics-announces-115-million-series-a-financing-302290888.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床1期寡核苷酸临床2期