This study aims to evaluate the efficacy and safety of 177Lu-PSMA-617 as a systemic therapy in patients with PSMA-positive advanced clear cell renal cell carcinoma (ccRCC).
The name of the study drug involved in this research study is:
-177Lu-PSMA-617 (a type of radioligand therapy)

开始日期2025-11-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06783348

/ Not yet recruiting临床2期IIT

Phase II Trial Evaluating the Efficacy of 177Lutetium-PSMA-617 Treatment in Patients With Metastatic Clear Cell Renal Carcinoma Cell With Progressive Disease on First-line or Second-line Systemic Treatment

Background This study is for adults with advanced kidney cancer that has spread to other parts of the body and has continued to progress despite treatment with immunotherapy and targeted therapy. Unfortunately, treatment options at this stage of the disease are limited. The existing treatments' ability to work against cancer has not been fully looked into.
Rationale The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient 177Lutetium-PSMA and has been used as a standard treatment for advanced prostate cancer since December 2022, can also help treat advanced kidney cancer.
The drug 177Lu-PSMA-617 is being tested as an experimental treatment that targets a specific protein on cancer cells. This protein, known as prostate-specific membrane antigen (PSMA), is present on the surface of kidney cancer cells. Therefore, before the treatment begins, participants will undergo a PET (positron-emission tomography) scan to check if their kidney cancer cells express high levels of PSMA. This scan uses a small amount of radioactive material (in the form of 177Lutetium) to visualize the presence of PSMA on the cancer cells. Only participants who test positive for PSMA can take part in the study. In this approach, PSMA serves two purposes. First, it helps assess whether the cancer expresses this protein and allows 177Lu-PSMA-617 to specifically target and attach to the cancer cells. Second, 177Lu-PSMA-617 delivers a small amount of radiation directly to the tumour, which helps kill cancer cells while minimizing damage to normal cells. This type of treatment is known as a radiopharmaceutical.
Objective The primary aims are to find out if 177Lu-PSMA-617 is useful against kidney cancer and to assess its safety. Throughout the study, participants will undergo several imaging assessments to check their disease and response to treatment.
The study also includes the collection of tissue samples. Together with the information collected from the imaging assessments, this will allow further research into markers that may lead to earlier detection of tumour spread or help identify individuals who may benefit more from treatment with 177Lu-PSMA-617.
Treatment All participants will receive 177Lu-PSMA-617 through an intravenous injection at a standard dose of 7,400 MBq (megabecquerel: a measure of radioactivity). Treatments will be administered approximately every six weeks, for a maximum of six times.
Blood tests are done before and during treatment to check the participant's health and to detect any early side effects from the treatment. Different types of scans are performed before, during, and after 177Lu-PSMA-617 administration to check how well the treatment is working. After treatment ends, follow-up visits will be scheduled every six weeks during the first year. In the second year, your doctor will decide how often you need to come in for visits. These appointments are important for monitoring how the body continues to respond to the treatment. The entire study period will last approximately two years from the time of study entry.
Participants
The study will include approximately 56 participants who will be tested for PSMA expression, to obtain a minimum of 48 participants expressing PSMA entering the study. To qualify, participants must:
* Be diagnosed with advanced kidney cancer previously treated with immunotherapy and targeted therapy.
* Test positive for PSMA on a PET scan.
* Be generally healthy and able to perform daily activities.
* Be at least 18 years of age.
Benefit-risk analysis The drug 177Lu-PSMA-617 has proven to work well in treating advanced prostate cancer and could be a promising new treatment possibility for kidney cancer, although this has not yet been shown. By joining this study, participants will contribute to valuable research to better understand kidney cancer and improve treatment options for future patients. Participating in this study offers a chance to try a new treatment, which might help people with advanced kidney cancer live longer and prevent the disease from getting worse, especially for those who have limited treatment options left after immunotherapy and targeted therapy.
With all new treatments, there are possible risks and side effects associated with them. Side effects of the drug 177Lu-PSMA-617 may include feeling tired, nausea, dry mouth, loss of appetite, and changes in blood cells. While not all side effects are known yet, the study team will carefully follow participants for any side effects during and after treatment. It is important to understand that while the study is being done to provide new information, there are still some questions on the treatment's safety and how well it will work.

开始日期2025-10-30

申办/合作机构-

100 项与镥[177Lu] 特昔维匹肽相关的临床结果

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100 项与镥[177Lu] 特昔维匹肽相关的转化医学

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100 项与镥[177Lu] 特昔维匹肽相关的专利（医药）

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600

项与镥[177Lu] 特昔维匹肽相关的文献（医药）

2025-07-01·NUCLEAR MEDICINE AND BIOLOGY

Enhancing the therapeutic index of [211At]YF2 with iodo pseudo carrier: A simple strategy for reducing accumulation in kidneys, salivary and lacrimal glands

Article

作者: Feng, Yutian ; Vaidyanathan, Ganesan ; Banks, Rebecca L ; Huynh, Truc T ; Zalutsky, Michael R

INTRODUCTION:

Low-molecular-weight (LMW) PSMA-targeted agents have enjoyed success; however, their off-target toxicity in normal tissues such as kidneys, salivary gland and lacrimal gland can be dose limiting. Herein, we have evaluated the effect of co-administration of the non-radioactive iodo pseudo carrier, iodo YF2, on the normal tissue uptake of [²¹¹At]YF2 in xenografted mice. The potential implications for clinical translation of these studies were investigated by evaluating the binding of LMW PSMA-targeted agents to murine and human PSMA.

METHODS:

[²¹¹At]YF2 was synthesized following established protocols. Groups of 5 mice bearing subcutaneous PSMA+ PC3 PIP xenografts received [²¹¹At]YF2 co-injected with varying i.v. doses of iodo YF2 (0-2 nmol), and the biodistribution was evaluated at 1 h post injection (p.i.). In another study, the biodistribution of [²¹¹At]YF2 alone and [²¹¹At]YF2 co-administered with 1.5 nmol iodo YF2 was evaluated at 1 and 8 h p.i. Bead-based radioligand binding assays were conducted for [¹³¹I]YF2 and several other LMW agents to compare their binding to human and murine PSMA.

RESULTS:

At 1 h, no significant difference was seen in kidney uptake of [²¹¹At]YF2 at iodo YF2 concentrations of 0, 0.05 and 0.1 nmol (p > 0.05), but renal accumulations significantly reduced by co-administering 2.0 nmol iodo YF2 (p < 0.0001). Decreases in salivary and lacrimal gland uptake also were observed at 1 h for [²¹¹At]YF2 co-injected with 0.1 nmol iodo YF2 (p < 0.05). A follow-up study revealed a kidney uptake of 1.8 ± 0.4 % ID/g for [²¹¹At]YF2 with 1.5 nmol iodo YF2, compared to 46.5 ± 7.7 % ID/g for [²¹¹At]YF2 alone at 8 h. Tumor uptake showed no significant difference (p > 0.05) between [²¹¹At]YF2 alone (17.1 ± 8.8 % ID/g at 1 h; 13.6 ± 5.3 % ID/g at 8 h) and [²¹¹At]YF2 plus 1.5 nmol iodo YF2 (12.8 ± 2.7 % ID/g at 1 h; 14.1 ± 3.2 % ID/g at 8 h). Bead-based radioligand binding assays showed that [¹³¹I]YF2 has the highest binding fractions to both human PSMA (94.1 ± 0.1 %) and murine PSMA (92.5 ± 0.2 %) with minimal differences between the two, while [¹⁷⁷Lu]PSMA-617 had the greatest species-dependent disparity with a binding fraction of 90.5 ± 0.3 % to human PSMA and 60.9 ± 1.4 % to murine PSMA.

CONCLUSIONS:

Co-administration of iodo YF2 reduced kidney uptake of [²¹¹At]YF2 and decreased accumulation in normal tissues with no significant change in tumor uptake. In some cases, there was a significant difference in binding to human and murine PSMA among LMW PSMA-targeted agents suggesting that particularly for some agents, applying mouse data to predict human dosimetry must be done with caution.

2025-06-23·Journal of Cancer Research and Clinical Oncology

Combinations of treatments based on radiotherapy or radionuclides to enhance immunotherapy efficacy in advanced prostate cancer: a systematic review.

Review

作者: Roberto, Rosenfeld ; Marco, Badalamenti ; Maria, Iannantuono Giovanni ; Michele, Ghidini ; Stefano, Sganga ; Elias, Chandran ; Marta, Scorsetti ; Sveva, Mortellaro ; Ciro, Franzese ; Ornella, Garrone

BACKGROUND:

Prostate cancer (PCa) has been considered an immunologically "cold tumor". Indeed, in advanced PCa, immune checkpoint inhibitors (ICIs) or anti-tumor vaccines have shown poor results in phase II and phase III trials with the exception of sipuleucel-T that showed a modest survival benefit. Radiotherapy and Targeted radioisotopes, such as ²²³Radium or ¹⁷⁷Lu-PSMA-617 monotherapy, contributed in prolonging the progression-free survival of PCa patients in second or third line. However, potential benefits of combination with immune therapies were inconstantly investigated and outcomes often were discordant.

OBJECTIVE:

Aim of this systematic review was to gather and analyze clinical evidence about benefits and risks of combining ionizing-radiation-based treatments with the main immunotherapies administed in clinical and experimental oncology for the setting of metastatic PCa.

METHODS:

We performed a systematic review according to the PRISMA-ScR criteria, investigating PubMed, Web of science, Embase and Medline databases from February 2000 to April 2024, searching for phase I to phase III clinical trials associating radiotherapy with immunotherapy (RT/IT) in metastatic PCa patients.

CONCLUSION:

We observed that combination of Ipilimumab with stereotactic beam radiotherapy (SBRT) at the dose of 8 Gy performed about 12 days (range 2-21) before immunotherapy was liked with trials with a significative gain in progression-free survival. Furtherly, we described better objective responses when immunotherapies, were associated with SBRT than radionuclides An exception was ¹⁷⁷Lu-PSMA-617, which showed promising synergic results after few cycles of standard doses, suggesting a possible enhancing of immune system, in particular when associated with anti-PD1 (pembrolizumab). Due to the few data reported in literature, both for radiotherapy and radionuclides, however, future randomized trials should confirm these data.

2025-06-19·RADIATION PROTECTION DOSIMETRY

Evaluation of external radiation exposure in patients treated with 177Lu-PSMA and radiation safety assessment of the patient caregivers

Article

作者: Abdolmaleki, Mohammadreza ; Koosha, Fereshteh ; Bayat, Zeinab ; Farzanehfar, Saeed ; Kasraie, Nima ; Abbasi, Mehrshad ; Sheikhzadeh, Peyman

Abstract:

This study evaluates dose rates at various distances and time intervals after 177Lu-PSMA treatment and assesses caregivers’ effective doses. Dose rates were measured in 47 patients at 0.5 and 1 m up to 168 h post-injection. Initial dose rates were 34.6 ± 9 μSv (0.5 m) and 24.6 ± 5 μSv (1 m) at 5 min, peaking at 48.5 ± 15 and 31.6 ± 8 μSv at 1 h, then declining significantly over time. Caregivers’ effective doses ranged from 20 to 1170 μSv, remaining below international safety limits. This study demonstrates that patient dose rates at a distance of 1-m decline to below 30 μSv/h within 2–3 h post-injection and fall further to under 20 μSv/h after 6 h. Patients may be considered radiologically safe approximately four days post-procedure, depending on individual factors. While 177Lu-PSMA is a safe and effective PRRT modality, strict safety measures are essential to minimize exposure risks.

813

项与镥[177Lu] 特昔维匹肽相关的新闻（医药）

2025-06-30

·PRNewswire

Alpha Fusion, Inc. and Curadh MTR, Inc. to Enter into Strategic Partnership to Advance Global Development of Astatine-211 Based Radiopharmaceuticals

TOKYO, June 30, 2025 /PRNewswire/ -- Alpha Fusion, Inc. ("Alpha Fusion") and Curadh MTR Inc. ("Curadh") announced plans to enter a strategic partnership, including a Joint Venture to broadly advance the global development of Astatine-211 (At-211) based radiopharmaceuticals. The collaboration combines Alpha Fusion's leading role in At-211 drug discovery and early clinical work in Japan, with Curadh's global expertise in radiopharmaceutical development. The Joint Venture will focus on clinical development of lead products in the US as well as broadly developing a pipeline of At-211 products. The partners announced their plans at the World Astatine Community Meeting. The therapeutic potential for At-211 by the Joint Venture was highlighted in talks given by the companies' scientific/clinical founders. Tadashi Watabe, M.D., Ph.D., FANMB, Department of Radiology, Graduate School of Medicine, University of Osaka presented "Progress Update on Astatine Clinical Trials in Osaka" as Principal Investigator of the studies. Alison Armour, MD., FRCP., FRCR, Founder and CMO of Curadh talked on "Why Astatine Will Be Important for The Future of Molecularly Targeted Radiopharmaceuticals" "Alpha Fusion is advancing its pipeline and building a highly efficient supply chain for At-211 using cyclotrons and GMP manufacturing in collaboration with partners across the globe" stated CEO Sunao Fujioka. "Our strategic partnership with Curadh, who has deep expertise in radiopharmaceuticals, will significantly accelerate expansion into the US and global market". "This strategic partnership with Alpha Fusion's foundational At-211 drug discovery platform and first-in-human studies strengthens our position in next-generation radiopharmaceuticals" added Glenn Kazo, CEO of Curadh. "Astatine's unique properties as a halogen emitter with a short half-life makes it one of the most promising alphas for molecularly targeted cancer therapy" About Alpha Fusion: Alpha Fusion Inc., established to commercialize Astatine drug discovery based on research from Osaka University and the Japan Science and Technology Agency, is dedicated to unleashing the therapeutic potential of Astatine therapy in the fast-emerging field of Targeted Alpha Therapy. Alpha Fusion Inquiries About Curadh. Curadh MTR, Inc., is dedicated to advancing second-generation radiopharmaceuticals through innovative drug design and strategic partnerships combining novel targets and new radioisotopes. Founded by Dr. Alison Armour, who led the clinical development of Pluvicto®, the world's leading radiopharmaceutical drug, Curadh is headed by an expert team in MTR development. Curadh Inquiries SOURCE Alpha Fusion Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025-06-28

·抗体圈

后PD-1时代，千亿肿瘤帝国变局开启，制药巨头大比拼

日前，默沙东宣布PD-1抑制剂Keytruda（K药）获FDA批准新适应症，用于肿瘤表达PD-L1（CPS≥1）的可切除局部晚期头颈部鳞状细胞癌（HNSCC）的围手术期治疗。这是该领域6年来的首个新药批准，也是全球首个获批用于HNSCC围手术期治疗的免疫药物。在K药这款划时代的PD-1抑制剂K药继续扩大适应症版图的硬币背面，是核心专利将在2028年到期。同时随着双抗、ADC等新疗法在各个细分适应症和靶点上展开激烈角逐，不断改写治疗规则。一场深刻影响全球千亿美元肿瘤市场格局的变局已然拉开序幕。一直以来，肿瘤是新药研发集中发力点，也是跨国制药巨头的核心战场与业绩支柱。这片看似平静的红海，实则暗流汹涌。MNC们正厉兵秣马，或加速内部研发，或豪掷千金“买买买”，力求在新时代占据制高点。谁将成为后PD-1时代的“新王”？答案正浮出水面。01群雄逐鹿，制药巨头肿瘤战略图谱1、默沙东：捍卫宝座，押注未来K药无疑是默沙东的“定海神针”，在2024年以18%的销售额增速飙升至294.82亿美元，稳坐全球“药王”宝座。作为获批适应症最广的PD-1抑制剂，K药构筑了默沙东肿瘤帝国的基石。面对2028年的专利到期压力，默沙东采取“双管齐下”策略：一方面，默沙东聚焦管线扩充与迭代：通过大手笔BD，与Seagen、VelosBio、科伦博泰、第一三共等公司合作，大规模布局下一代肿瘤疗法，聚焦ADC药物（如靶向HER3、B7H3、CDH6、Trop2等），覆盖肺癌、乳腺癌、消化道肿瘤等关键领域，接力K药并巩固其在实体瘤的领导地位。另一方面，默沙东显著加大研发投入，2024年其III期临床管线规模相比2021年几乎翻了两倍，预计未来几年还将推出有20款潜在“重磅炸弹”药物，并把2030年肿瘤业务收入预期从200亿美元大幅上调至250亿美元，彰显对未来增长的信心。无论是大规模BD合作，还是激进的研发投入，都是为了填补K药专利到期后留下的空白，更是为了在精准靶向、联合治疗的新战场上抢占制高点。2、BMS：转型阵痛，寻求突破BMS一季度总营收为112亿美元，同比减少6%，整体营收承压，但在肿瘤领域的表现依然亮眼。肿瘤业务中，Opdivo（纳武利尤单抗）和Opdualag（纳武利尤单抗+瑞拉利单抗）贡献了主要业绩。Opdivo作为BMS的明星产品，在免疫肿瘤治疗领域占据重要地位。2025年第一季度，Opdivo的销售额达到了22.65亿美元，显示了其强大的市场吸金能力。继来那度胺在2023年专利到期后，O药将在2027年到期，带给BMS严峻的专利悬崖挑战。届时，仿制药会迅速入局，将直接导致原研药的市场垄断地位丧失，从而引发产品销售额急剧下滑。在承压之下，BMS正在加快自己的收购步伐，甚至计划斥巨资收购BioNTech。毕竟BioNTech的mRNA技术和一系列有前景的肿瘤管线，可极大地弥补BMS核心产品专利到期后的收入缺口。通过全面收购，BMS还可直接掌控BioNTech多个处于临床阶段的肿瘤候选药物，增强在肿瘤领域的领导地位。可以确认的是，如何有效弥补O药下滑带来的巨大缺口，并找到新的强劲增长点，是BMS转型的关键。3、罗氏：多领域齐头并进昔日的“肿瘤霸主”罗氏，已成功转型为覆盖肿瘤、神经科学、眼科、免疫及感染性疾病五大核心领域的多元化巨头。2024年，其肿瘤业务收入达237.44亿瑞士法郎（约270.40亿美元），实力依然雄厚。在实体瘤领域，罗氏拥有Tecentriq（阿替利珠单抗）、Perjeta（帕妥珠单抗）、Kadcyla（恩美曲妥珠单抗）等重要产品。其真正的核心竞争力在于血液肿瘤领域。凭借美罗华（Rituxan，利妥昔单抗）、优罗华（Gazyva/Gazyvaro，奥比妥珠单抗）、佳罗华（Polivy，泊洛妥珠单抗）等覆盖从淋巴瘤到多发性骨髓瘤的丰富管线，罗氏在全球及中国血液肿瘤市场长期占据“一哥”地位。同时，罗氏持续推进血液瘤产品迭代，并加强实体瘤领域新药研发（如双抗、ADC等），巩固多元化优势。4、阿斯利康：全面开花，增长强劲阿斯利康近年来肿瘤业务突飞猛进，呈现“全面开花”态势。财报显示，其全年营收540.73亿美元，同比增长21%；其中肿瘤业务贡献223.53亿美元，同比大增24%，占总营收高达41%，是其增长的核心引擎。凭借Tagrisso（奥希替尼）、Lynparza（奥拉帕利）、Imfinzi（度伐利尤单抗）、Enhertu（德曲妥珠单抗）等覆盖肺癌、乳腺癌、卵巢癌、前列腺癌等多瘤种的重磅产品组合，阿斯利康成功跻身肿瘤领域顶级玩家。目前阿斯利康持续深化现有产品适应症拓展，并积极布局下一代疗法（如ADC、细胞疗法、核药），利用其强大的商业化能力和BD策略巩固增长势头。5、强生：肿瘤业务达到新高度在多年布局之下，强生实现了肿瘤业务的重大里程碑。2024年，其肿瘤业务年度销售额首次突破200亿美元大关，创收207.81亿美元，一举超越免疫业务，跃升为强生创新药收入的第一大来源。其中，多发性骨髓瘤领域的“王者”Darzalex（达雷妥尤单抗）及其组合疗法的迅猛增长功不可没。强生在血液肿瘤（尤其是多发性骨髓瘤）领域构建了极其强大且层次分明的产品管线，涵盖小分子化药、单抗、双抗（如Tecvayli, Talvey）、CAR-T细胞疗法（Carvykti），实现了对患者从末线到一线治疗的全覆盖。另外，强生积极通过收购补充管线，如2024年斥资20亿美元收购ADC公司Ambrx，旨在将技术平台拓展至实体瘤领域，寻求新的增长点。02肿瘤千亿市场变局，谁将成为新王？K药和O药的专利到期是未来几年重塑市场格局的最大变量。仿制药（生物类似药）的涌入将导致这两款“现金奶牛”销售额大幅下滑，迫使默沙东和BMS加速转型，同时也为罗氏、强生等其他竞争者以及新兴生物技术公司，提供了抢占市场份额的窗口期。而在后PD-1时代，竞争焦点实际上转向更精准、更有效的下一代疗法。ADC 已成为当前最热门的领域，默沙东、阿斯利康、罗氏、辉瑞等巨头重金押注，针对不同靶点的ADC管线竞争白热化。比如，PD-L1靶向ADC的亮相。PD-L1 ADC原理上，沿袭了PD-L1靶点的广谱性特征，也实现了ADC载荷与免疫激活的协同效应，为解决传统免疫治疗的耐药性问题提供了创新性解决方案。在ADC之外，双抗/多抗技术凭借其能同时靶向多个抗原或免疫细胞的独特优势，在血液瘤领域展现出巨大潜力，包括滤泡性淋巴瘤、多发性骨髓瘤和弥漫性大 B 细胞淋巴瘤。如罗氏的 Lunsumio (mosunetuzumab)是靶向CD20/CD3的双抗药物，用于治疗复发或难治性滤泡性淋巴瘤。而以CAR-T为代表的细胞疗法已在血液系统恶性肿瘤治疗中取得革命性进展，显著改善了部分难治、复发患者的生存预后。如强生/传奇生物的Carvykti，BMS的Abecma等。而随着去年，美国Iovance 公司的Lifileucel（Amtagvi）获批上市，成为全球首款上市的TIL疗法，细胞疗法开始迈入实体瘤时代。但TIL疗法作为新疗法，价格高昂，治疗方案复杂，目前可及性较低。像Amtagvi定价为51.5万美金（约370万人民币），使用之前还需要深度清淋，繁琐且周期长。针对特定癌症类型，放射性药物提供了创新的治疗选择，尤其在精准递送辐射杀伤癌细胞方面优势显著。诺华重金布局了以放射配体疗法为代表的核药领域，拥有Pluvicto和Pluvicto两款获批上市的产品。像Pluvicto针对的是男性第二大癌种—前列腺癌。事实上，全球癌症发病率仍在持续上升，市场上有着巨大的、远未被满足的临床需求。技术进步带来更多治疗选择，驱动市场持续增长。据Evaluate Pharma预测，到2030年，全球肿瘤治疗市场总规模有望突破3700亿美元。未来肿瘤市场的“新王”，并非单指某一家公司，更可能是在不同细分领域占据领先地位的多家巨头。决定胜负的关键在于拥有的下一代管线的深度与广度，包括在ADC、双抗、细胞疗法等前沿领域拥有的竞争力、覆盖关键靶点和适应症的管线、并能高效推进上市。拥有强大管线是基础，能否在全球市场高效推广并实现产品价值最大化，同样考验药企的商业化功底。结语：K药、O药专利到期将如同一声发令枪，宣告肿瘤治疗领域一个旧时代的结束和一个新时代的开启。谁能在后PD-1时代脱颖而出，不仅取决于其现有产品的护城河，更取决于对未来趋势的前瞻布局、对创新技术的有效获取与整合能力，以及在激烈竞争中高效的执行落地。这场关乎未来“肿瘤之王”归属的竞赛，已经进入最关键的冲刺阶段。市场格局的重塑，就在眼前。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

抗体药物偶联物专利到期免疫疗法引进/卖出

2025-06-24

·ioncology

初心如磐，循新致远——2025版《CSCO前列腺癌诊疗指南》全新发布！

点击蓝字，关注我们泌尿外科领域目光聚焦，翘首以盼，2025版《CSCO前列腺癌诊疗指南》重磅发布时刻如约而至！回溯历程，CSCO前列腺癌专委会指南编写组于今年2月启动指南更新修订工作，全体编委和执笔专家立足中国国情、紧跟国际前沿，经过反复研讨，最终正式定稿。6月19日线上发布会的顺利召开，将持续为我国前列腺癌诊疗实践注入专业指引，守护前列腺癌患者健康福祉。接下来，就让我们一同深入探寻2025版指南的更新要点，解码前列腺癌诊疗领域的全新方向！大咖擎旗，破局拓新，锚定前列腺癌诊疗新航向会议开始，由CSCO前列腺癌专委会主任委员、CSCO前列腺癌诊疗指南编写组组长、复旦大学附属肿瘤医院叶定伟教授做了精彩致辞，指出：自CSCO前列腺癌诊疗指南首版发布以来，凭借其不可或缺的临床价值，已成为国内泌尿外科同仁日常工作的重要参考与依据。《CSCO前列腺癌诊疗指南》的年度更新工作，始终坚持立足中国患者特点，紧密追踪国际前沿进展，旨在为国内真实诊疗场景提供最科学、最实用的实践指引。本次更新历时数月，是全体编委经过反复讨论，多次修改的智慧结晶。2025年CSCO前列腺癌诊疗指南的发布，将进一步推动全国前列腺癌诊疗规范化，助力“健康中国2030”战略，最终惠及广大前列腺癌患者！循证为基，探新求进，开启前列腺癌诊疗新篇章在复旦大学附属肿瘤医院叶定伟教授、北京大学肿瘤医院郭军教授的主持引导下，首先由CSCO前列腺癌专家委员会秘书长、复旦大学附属肿瘤医院朱耀教授解读了2025 CSCO前列腺癌指南更新要点，指出本次指南更新围绕“诊断技术革新，精准判型升级；疾病策略优化，多元治疗并进；联合治疗创新，患者精细管理”这三个主题。朱耀教授指出：全球前列腺癌病例激增，中国前列腺癌近十年发病率与死亡率逐年增加，疾病负担较重，需开展早筛早诊。新型诊断技术的普及与穿刺策略的优化将带来更高的临床显著性前列腺癌（csPC）检出率、更准确的疾病分期。在疾病治疗策略方面，多种治疗模式齐头并进。在局限性和转移性激素敏感性前列腺癌中，局部治疗与全身治疗的加法极大地提升了患者获益。而对于激素抵抗性前列腺癌，PARP抑制剂联合NHA等联合治疗方案不断创新，未来依托基因分型/分子影像/转移部位等指导的更为精细化的患者个体化治疗将为前列腺癌治疗带来新的选择和希望。四川大学华西医院曾浩教授介绍了“前列腺癌的MDT诊疗模式”、“前列腺癌基因检测和液体活检”、“随访”三个章节的更新要点，具体如下：“前列腺癌基因检测和液体活检”章节：转移性前列腺癌Ⅱ级推荐基因类型新增“肿瘤突变负荷（TMB）或肿瘤微卫星不稳定（MSI）”，局限性或区域淋巴结转移性前列腺癌Ⅲ级推荐基因类型新增描述“如TP53、RB1、PTEN等”，同时新增检测方式的推荐。主要基于免疫检查点抑制剂和AKT抑制剂等的临床研究进展。“随访”章节：调整优化治愈后诊疗及综合治疗后随访检查内容与频率。在四川大学华西医院魏强教授、北京大学第一医院何志嵩教授的主持引导下，山东大学齐鲁医院的陈守臻教授、北京大学第一医院范宇教授、中山大学肿瘤防治中心李永红教授分别对“前列腺癌的筛查和诊断”、“局限性前列腺癌的风险分层和极低危、低危前列腺癌的治疗”“局限性和区域淋巴结转移前列腺癌”部分进行了更新解读，具体如下：“前列腺癌的筛查”章节：筛查对象Ⅰ级推荐中“年龄＞45岁且有前列腺癌家族史的男性”的描述调整为“年龄＞45岁且为家族性或遗传性前列腺癌家系中的男性”，并增加相应注释。“前列腺癌的诊断”章节：前列腺癌的检查方法：Ⅱ级推荐新增“前列腺癌抗原3（PCA3）”，在PSA升高的患者中，使用PCA3作为诊断标志物比使用tPSA、fPSA比值等更能提高前列腺癌的诊断准确率。前列腺穿刺：在前列腺初次穿刺指征中，增加了PCA3。PCA3基因表达检测可作为辅助诊断工具，用于评估总PSA水平在4～10ng/ml范围内的患者是否需要进行前列腺穿刺活检。“局限性前列腺癌的治疗”章节：极低危局限性前列腺癌的治疗：将“观察等待（1B类）”由Ⅱ级推荐提升为Ⅰ级推荐，并添加了适用人群的描述“预期寿命<10年”。低危局限性前列腺癌的治疗：根治术后辅助治疗Ⅰ级推荐“观察随访（术后，无淋巴结转移或无多种高危特征（1A类）”删除了“或无多种高危特征”的适用人群描述。中危局限性前列腺癌的治疗：Ⅰ级推荐“前列腺癌根治术±盆腔淋巴结清扫（1A类）”注释更新：目前盆腔淋巴结清扫术是否带来生存获益仍不明确，PSMA PET/CT较传统影像学诊断盆腔淋巴结转移敏感性更高，有研究认为可替代盆腔淋巴结清扫术，但扩大盆腔淋巴结清扫术仍为当前盆腔淋巴结分期的金标准。建议术前与患者讨论盆腔淋巴结清扫术与PSMA-PET/CT的风险和获益。高危和极高危局限性前列腺癌的治疗：更新了高危和极高危的定义。主要基于STAMPEDE研究对high-risk局限晚期前列腺癌的定义。区域淋巴结转移前列腺癌的治疗：初始治疗Ⅱ级推荐新增“ADT+阿比特龙（2年）（2A类）”，基于STAMPEDE研究，无论是否接受放疗，ADT联合阿比特龙均可降低患者治疗失败风险。在山东大学齐鲁医院史本康教授、中山大学肿瘤防治中心周芳坚教授的主持引导下，中山大学肿瘤防治中心何立儒教授、上海交通大学医学院附属新华医院刘海龙教授、北部战区总医院的郭放教授分别对“前列腺癌的放射治疗”、“前列腺癌治愈性治疗后复发的诊疗”、“转移性激素敏感性前列腺癌的诊疗”部分进行了更新解读。“前列腺癌的放射治疗”部分：基于最新证据对放疗联合ADT的证据等级进行了调整。局限性前列腺癌的治疗：对根治术后辅助治疗的Ⅱ级推荐“EBRT±ADT（淋巴结转移）（1B类）”由1B类证据调整为2A类。基于缺乏3期RCT的明确OS获益证据。区域淋巴结转移前列腺癌的治疗：将初始治疗的Ⅰ级推荐“EBRT+ADT（2～3年）（2A类）”由2A类证据提升为1B类。基于多项回顾性大样本研究显示放疗联合ADT疗效优于单纯ADT。STAMPEDE研究的亚组分析显示，放疗显著改善2年无失败生存率（89% vs. 64%）“前列腺癌治愈性治疗后复发的诊疗”章节：前列腺癌根治术后复发的治疗：生化复发/局部复发的Ⅱ级推荐新增“ADT+阿帕他胺（2B类）”，主要基于PRESTO研究：ADT+阿帕他胺较ADT显著降低疾病进展风险，中位PSA-PFS为24.9个月对比20.3个月（HR=0.52）。注释中添加了22基因GC评分有助于指导EBRT联合内分泌治疗决策，基于RTOG 9601研究事后分析。“转移性激素敏感性前列腺癌的诊疗”章节：低瘤负荷转移性激素敏感性前列腺癌：新增Ⅰ级推荐“ADT+达罗他胺（1A类）“和Ⅱ级推荐“ADT+瑞维鲁胺（2B类）”；高瘤负荷转移性激素敏感性前列腺癌：新增Ⅰ级推荐“ADT+达罗他胺（1B类）”。主要基于：ARANOTE研究显示达罗他胺联合ADT对比安慰剂联合ADT可显著改善mHSPC患者rPFS（HR 0.54）；国内一项真实世界研究表明瑞维鲁胺联合ADT可作为低瘤负荷转移性激素敏感性前列腺癌的治疗选择。并更新了注释。在北部战区总医院谢晓冬教授、上海交通大学医学院附属新华医院齐隽教授的主持引导下，北京大学肿瘤医院的盛锡楠教授解读了“去势抵抗性前列腺癌的诊疗”的更新要点，复旦大学附属肿瘤医院的卞晓洁教授对于“前列腺癌特定亚型的诊疗”章节进行了更新解读。“去势抵抗性前列腺癌的诊疗”章节：优化了“转移性去势抵抗性前列腺癌的诊疗”章节中治疗方案的推荐，并更新了注释。在既往未经新型内分泌治疗和化疗组别里，Ⅰ级推荐新增“镭-223+恩扎卢胺（骨转移）（1A类）”，Ⅱ级推荐新增“他拉唑帕利+恩扎卢胺（2A类）”，“氘代恩扎卢胺（2B类）”。既往新型内分泌治疗失败且未经化疗组别中，Ⅱ级推荐新增“177Lu-PSMA-617（1A类）”，“氘代恩扎卢胺（2B类）”，删除“卡巴他赛（1B类）”。既往多西他赛化疗失败且未经新型内分泌治疗组别中，Ⅲ级证据新增“他拉唑帕利（HRR突变）（2B类）”。既往新型内分泌治疗和多西他赛化疗失败组别中，Ⅰ级推荐新增“177Lu-PSMA-617+SOC（1A类）”，“氘代恩扎卢胺（1A类）”，Ⅱ级推荐新增“卡巴他赛（1B类）”，Ⅲ级证据新增“他拉唑帕利（HRR突变）（2B类）”并删除“镭-223+恩扎卢胺”。主要基于PEACE3、PSMAfore、HC-1119-04、TALAPRO-2等研究结果。预防及治疗骨相关事件的骨改良药物中新增推荐“纳鲁索拜单抗”，并在注释中增加相应证据。“前列腺癌特定亚型的诊疗”章节：更多高等级循证医学证据的产生将有助于指导前列腺癌特定亚型的诊疗。在发布会的最后，CSCO前列腺专委会主任委员，大会主席叶定伟教授对大会进行了精彩的总结：感谢各位编写组成员的辛劳付出和详细解读，2025版《CSCO 前列腺癌诊疗指南》的更新和修订，凝集了我国顶尖泌尿外科专家的智慧与经验，期待本指南能够最大化的在泌尿外科医生的临床工作中发挥作用，指南的落地将进一步引领我国前列腺癌临床诊疗的规范化，共创2030健康中国！（来源：CSCO PC）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

CSCO会议

100 项与镥[177Lu] 特昔维匹肽相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	加拿大	Advanced Accelerator Applications USA, Inc.	2022-08-25
PSMA阳性去势抵抗性前列腺癌	美国	Novartis Pharmaceuticals Corp.	2022-03-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
转移性前列腺癌	临床3期	法国	Novartis AG	2024-09-12
寡转移性前列腺癌	临床3期	美国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	中国	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	日本	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	阿根廷	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	奥地利	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	比利时	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	巴西	Novartis Pharmaceuticals Corp.	2024-03-12
寡转移性前列腺癌	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2024-03-12

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04443062 (BULLSEYE trial, ASCO2025)	临床2期	去势敏感前列腺癌 PSMA-expressing	58	Lutetium-177-PSMA-617	淵艱選齋廠積壓淵壓遞(衊窪顧糧壓夢獵憲艱鹽) = 淵鏇夢窪糧製餘衊襯夢鑰艱願鏇艱糧鑰鹽顧製 (選壓鹽鑰願顧網獵廠醖 ) 更多	积极	2025-05-30
				Lutetium-177-PSMA-617 (Standard of Care (SoC) - Deferred ADT)	淵艱選齋廠積壓淵壓遞(衊窪顧糧壓夢獵憲艱鹽) = 鏇繭壓憲構顧範觸憲鏇鑰艱願鏇艱糧鑰鹽顧製 (選壓鹽鑰願顧網獵廠醖 ) 更多
ASCO2025	N/A	转移性去势抵抗性前列腺癌 PSMA expression	214	Enzalutamide	鏇選遞築製醖顧衊範鹹(網鏇蓋鑰憲顧築範觸憲) = 築齋積鹹鏇膚廠餘顧顧築廠願蓋襯繭構觸鬱範 (獵構鏇衊範憲鹽顧網鏇 ) 更多	积极	2025-05-30
				Abiraterone Acetate	鏇選遞築製醖顧衊範鹹(網鏇蓋鑰憲顧築範觸憲) = 積膚壓顧鑰淵壓遞壓選築廠願蓋襯繭構觸鬱範 (獵構鏇衊範憲鹽顧網鏇 ) 更多
PRECISION (ASCO2025)	N/A	转移性去势抵抗性前列腺癌 prostate-specific antigen	431	Prompt initiation of 177Lu-PSMA-617	壓鹹簾選築憲艱襯窪窪(簾壓膚膚夢壓艱顧獵糧) = 選製製鹽觸夢觸製醖齋憲糧築夢選製觸壓鑰鏇 (襯願鑰網網蓋襯積齋糧 ) 更多	积极	2025-05-30
				Deferred initiation of 177Lu-PSMA-617	壓鹹簾選築憲艱襯窪窪(簾壓膚膚夢壓艱顧獵糧) = 遞遞範齋鬱廠憲鏇製餘憲糧築夢選製觸壓鑰鏇 (襯願鑰網網蓋襯積齋糧 ) 更多
ASCO2025	N/A	转移性去势抵抗性前列腺癌 RB1 \| PTEN \| HRR genes	117	177Lu-PSMA-617 (Luminal A-like (LumA))	築壓鑰衊鑰範繭鏇製觸(淵鏇繭蓋鬱廠製鏇壓鬱) = 積範夢顧鏇夢鑰製積糧憲鹹繭鹹夢鑰選膚壓構 (衊窪糧簾糧獵觸獵膚繭 )	积极	2025-05-30
				177Lu-PSMA-617 (Luminal B-like (LumB))	築壓鑰衊鑰範繭鏇製觸(淵鏇繭蓋鬱廠製鏇壓鬱) = 醖齋醖鏇膚壓網壓窪網憲鹹繭鹹夢鑰選膚壓構 (衊窪糧簾糧獵觸獵膚繭, 9.1[3.8 ~ 21.8])
TriNetX database (ASCO2025)	N/A	转移性去势抵抗性前列腺癌三线 PSA50	-	177Lu-vipivotide tetraxetan PSMA	遞繭餘衊築壓齋廠糧願(壓齋夢鏇繭襯範艱繭憲) = significantly lower rates with 177Lu-PSMA 鹹鬱廠餘鏇鑰衊願襯艱 (憲壓鏇觸簾醖衊憲醖艱 ) 更多	积极	2025-05-30
				Cabazitaxel
PRECISION (ASCO2025)	N/A	转移性去势抵抗性前列腺癌 prostate-specific antigen	152	Abiraterone	構選築齋觸願簾窪簾壓(遞顧壓鑰鬱簾襯夢鹽簾) = 遞襯糧窪襯築壓衊襯網膚積製糧窪壓構網顧糧 (構範憲淵糧蓋範膚鹹餘 ) 更多	积极	2025-05-30
				Enzalutamide	構選築齋觸願簾窪簾壓(遞顧壓鑰鬱簾襯夢鹽簾) = 艱鏇淵鏇網繭遞獵齋構膚積製糧窪壓構網顧糧 (構範憲淵糧蓋範膚鹹餘 ) 更多
VISION and EAP (ASCO2025)	N/A	转移性去势抵抗性前列腺癌 prostate specific membrane antigen	51	Lutetium-177 vipivotide tetraxetan	範鬱簾網蓋醖鏇鑰淵壓(網醖淵壓壓窪築簾鑰醖) = 顧齋衊鑰夢製廠窪鏇淵築夢壓繭蓋餘鬱顧構遞 (蓋衊廠願窪窪網鑰鏇鬱, 9.4 ~ 25)	不佳	2025-05-30
NCT06216249 (FLEX-MRT, ASCO2025)	临床2期	转移性去势抵抗性前列腺癌 PSMA positron emission tomography (PET)	90	Flexible dosing schedule of 177Lu-PSMA-617 RPT up to 12 cycles	蓋襯製鑰憲艱鹹積範糧(鹹顧觸築築構壓齋艱糧) = 夢淵繭襯遞蓋構獵繭顧製窪醖鹹鑰鹽鏇製觸夢 (鹽鏇鏇遞衊簾艱鏇齋廠 )	积极	2025-05-30
				Fixed dosing schedule of 177Lu-PSMA-617 RPT 6 cycles	蓋襯製鑰憲艱鹹積範糧(鹹顧觸築築構壓齋艱糧) = 簾艱鹽淵夢夢繭壓餘蓋製窪醖鹹鑰鹽鏇製觸夢 (鹽鏇鏇遞衊簾艱鏇齋廠 )
NCT05150236 (EVOLUTION; ANZUP2001, ASCO2025)	临床2期	转移性去势抵抗性前列腺癌 PSMA-positive	93	LuPSMA alone	鏇範獵襯蓋憲襯憲顧壓(鏇簾壓獵糧襯鏇鹹鹽鏇) = There were 2 deaths during LuPSMA+ICI treatment: myocarditis (treatment related) and sepsis (not treatment related) 鬱願醖膚襯糧窪憲鏇衊 (窪壓餘獵鹽壓網顧糧構 ) 更多	积极	2025-05-30
				LuPSMA+ICI (ipilimumab and nivolumab)
AACR2025	N/A	前列腺癌	117	177Lutetium-PSMA-617 (Luminal A-like (LumA))	齋顧鑰遞鹹範構餘蓋齋(遞顧窪蓋構鏇壓壓製餘) = 壓顧鬱顧餘糧醖鑰鹽網餘襯遞襯壓窪糧壓窪淵 (醖膚艱願憲廠觸憲蓋鬱 )	积极	2025-04-28
				177Lutetium-PSMA-617 (Luminal B-like (LumB))	齋顧鑰遞鹹範構餘蓋齋(遞顧窪蓋構鏇壓壓製餘) = 顧願鬱構觸蓋艱齋艱醖餘襯遞襯壓窪糧壓窪淵 (醖膚艱願憲廠觸憲蓋鬱 )