This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng/mL and who have undergone complete prostatectomy and/or will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET/CT only with bicalutamide standard of care) or Group B (baseline PSMA PET/CT and an additional PSMA PET/CT after 2 weeks of bicalutamide).

开始日期2026-10-31

申办/合作机构

Washington University School of Medicine

[+1]

NCT06881823

/ Withdrawn临床1/2期

NeoPSMA: A Phase I/II, Open-label, Multi-center Study of Neoadjuvant Treatment With [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Adults With Prostate-specific Membrane Antigen (PSMA) Positive High-risk Localized Prostate Cancer (HRLPC) Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection

The purpose of this trial is to learn more about the effects of AAA602 and AAA802 in men with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) before surgery to remove the prostate and lymph nodes present in the pelvis area. Lymph nodes are small structures near the prostate that help fight infections. These lymph nodes are removed during surgery because they are a site the disease can spread to.

开始日期2026-06-29

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

NCT07285057

/ Recruiting临床2期IIT

Diagnostic Utility of rhPSMA-7.3 (18F) PET /CT Imaging in Patients With Prostate Cancer on Active Surveillance

This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET/CT (flotufolastat F18, marketed as POSLUMA®) in men with biopsy-proven, low-risk or favorable intermediate-risk prostate cancer managed with active surveillance. The study aims to determine whether the addition of PSMA-based PET/CT to standard multiparametric MRI (mpMRI) improves detection of clinically significant prostate cancer compared to MRI alone. Eligible participants will undergo rhPSMA-7.3 (¹⁸F) PET/CT and mpMRI prior to confirmatory prostate biopsy. Biopsies will target areas identified on MRI, PET/CT, or both, and histopathologic outcomes will serve as the reference standard. The study will assess lesion-level concordance between PET/CT, MRI, and pathology, and evaluate the predictive value of PET/CT for disease upgrading. Approximately 120 participants will be enrolled at Mount Sinai Hospital over 12 months. Study participation will involve one imaging visit, one confirmatory biopsy, and follow-up through review of clinical results. There is minimal risk to participants beyond standard diagnostic procedures. The study is funded jointly by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics, which provides the imaging agent flotufolastat F18 and technical support.

开始日期2026-02-10

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+1]

100 项与氟[18F]妥司特相关的临床结果

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100 项与氟[18F]妥司特相关的转化医学

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100 项与氟[18F]妥司特相关的专利（医药）

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项与氟[18F]妥司特相关的文献（医药）

2026-05-01·European Journal of Nuclear Medicine and Molecular Imaging

An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy

Article

作者: Purysko, Andrei S ; Sykes, James ; Pathak, Ram A ; Shore, Neal ; Andrews, Jack R ; Josephson, David ; Gartrell, Benjamin A ; Saltzstein, Daniel R ; Nordquist, Luke T ; Kuo, Phillip H ; Penny, Ross ; Davis, Phillip ; Helfand, Brian T

Abstract:

Purpose:

This prospective, multicentre, intra-patient comparator study assessed urinary radioactivity, and patient-level and region-level detection rates (DR) with PSMA-PET radiopharmaceuticals, 18 F-piflufolastat ( 18 F-DCFPyL) and 18 F-flotufolastat ( 18 F-rhPSMA-7.3) in patients with biochemical recurrence (BCR) of prostate cancer to evaluate the hypothesis that lower urinary radioactivity is observed with 18 F-flotufolastat.

Methods:

Patients with low PSA (≤0.5 ng/mL) BCR ≥6 months post-prostatectomy with undetectable PSA post-surgery, scheduled for standard-of-care 18 F-piflufolastat PSMA-PET were enrolled. Patients underwent PET/CT 60 minutes post- 18 F-piflufolastat (9 mCi) administration, and a second PET/CT on the same scanner 1–10 days later, 60 minutes post- 18 F-flotufolastat (8 mCi) administration. The primary endpoint was the difference in urinary radioactivity (SUV mean ) between the radiopharmaceuticals. Secondary endpoints included patient-level and region-level DR for each radiopharmaceutical, assessed by two blinded readers (a third resolved disagreements, allowing majority reads).

Results:

Fifty-five evaluable patients (mean PSA, 0.28 ng/mL) were enrolled. Median bladder SUV mean was significantly higher with 18 F-piflufolastat (29.0; interquartile range, 18.9–40.8) than 18 F-flotufolastat (10.9; interquartile range, 6.0–18.5; p < 0.001 [Wilcoxon signed-rank test]). Majority read patient-level DR were 27.3% (15/55) for 18 F-piflufolastat and 45.5% (25/55) for 18 F-flotufolastat. Region-level DR for 18 F-piflufolastat and 18 F-flotufolastat, were 10.9% (6/55) and 18.2% (10/55) in the prostate bed, 14.5% (8/55) and 16.4% (9/55) in pelvic lymph nodes, and 7.3% (4/55) and 21.8% (12/55) in extra-pelvic sites. Among patients with PSA ≤0.2 ng/mL, 38.1% (8/21) and 52.4% (11/21) had positive 18 F-piflufolastat and 18 F-flotufolastat scans, respectively.

Conclusions:

This intra-patient comparator shows 18 F-flotufolastat has significantly lower urinary radioactivity than 18 F-piflufolastat, which may help to optimise image assessment in regions close to the urinary tract.

Clinical trial registration:

Trial registration, clinicaltrials.gov: NCT06604442. Registered September 2024.

2026-05-01·Urology Practice

Utility of ¹⁸ F-Flotufolastat Positron Emission Tomography/Computed Tomography Imaging in High-Risk Prostate Cancer in a Real-World Setting

Article

作者: Zinar, Cheryl ; Stollman, Nachum ; Meyer, Kayla ; Belkoff, Laurence ; Taylor, Zachariah ; Zeltser, Ilia

INTRODUCTION:

This investigator-initiated, prospective, low-intervention, phase 3 study evaluated the clinical utility of prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/CT imaging with ¹⁸F-flotufolastat (formerly ¹⁸F-rhPSMA-7.3) in men with newly diagnosed high-risk prostate cancer (PCa) and negative conventional imaging. The primary end point was the rate of clinical upstaging and its effect on subsequent management.

METHODS:

A total of 113 treatment-naïve men meeting National Comprehensive Cancer Network high-risk criteria were enrolled; 110 underwent PSMA PET/CT with ¹⁸F-flotufolastat. Before imaging, all patients had negative conventional staging, as determined by bone scan and CT or MRI. Imaging was performed 50 to 70 minutes post injection of 8 mCi ± 20% ¹⁸F-flotufolastat. The results were interpreted by board-certified nuclear medicine physicians trained in PSMA imaging.

RESULTS:

¹⁸F-flotufolastat identified extraprostatic disease in 36 of 110 patients (32.7%). Among them, 15 of 36 (41.7%) had isolated regional lymph node (N1) involvement, while 21 of 36 (58.3%) demonstrated distant metastatic (M1) disease. Of the patients who were upstaged, 34 of 36 patients (94.4%) had a change in their treatment plan. The most common treatment intensification included the addition of an androgen receptor inhibitor and expanded radiotherapy fields (50.0%). Furthermore, 34.3% received up-front chemotherapy alongside an androgen receptor inhibitor and radiation. A minority (8.6%) proceeded with radical prostatectomy as a first step of a multimodality approach.

CONCLUSIONS:

PSMA PET/CT with ¹⁸F-flotufolastat led to clinical upstaging in nearly one-third of men with high-risk PCa and negative conventional imaging, resulting in significant treatment change in most patients. These findings support the integration of PSMA-targeted imaging into initial staging pathways for men with high-risk PCa.

2025-12-01·Journal of Nuclear Medicine Technology

Prostate Cancer Imaging with ¹⁸ F-Flotufolastat

Review

作者: Tempesta, Daniel ; Gilmore, David

Medical imaging is often used to determine the staging of the cancer and if it is localized or if it has spread. Metastatic prostate cancer is the concern and the lower survival rate, if not detected. Nuclear medicine has played a pivotal role in prostate metastasis detection and treatment for many decades. The emergence of prostate-specific membrane antigen (PSMA)-targeted PET radiopharmaceuticals has significantly advanced the imaging of prostate cancer. Among these, ¹⁸F-flotufolastat, commercially known as Posluma, represents a pivotal development in the detection and management of PSMA-positive lesions. Its favorable pharmacokinetics-including low urinary excretion and minimal bladder activity-enhance lesion detectability in the pelvic region, a common challenge in prostate imaging. Clinical trials such as LIGHTHOUSE and SPOTLIGHT demonstrated ¹⁸F-flotufolastat's high specificity, diagnostic accuracy, and safety profile across diverse patient populations. With a cyclotron-produced ¹⁸F isotope and a 110-min half-life, ¹⁸F-flotufolastat offers logistical advantages for imaging centers and flexibility in scan timing. As a PSMA-based agent, ¹⁸F-flotufolastat enables precise visualization of prostate cancer cells and metastatic sites, positioning it as a valuable tool in the evolving landscape of nuclear medicine and prostate cancer care.

136

项与氟[18F]妥司特相关的新闻（医药）

2026-11-03

·行业的同行者-

12年、12条管线、3个基地：先通医药的官网自述，和它没说出口的部分

👇 点击下方关注　｜　核药产业观察行业同行者　·　核药公司档案 12年、12条管线、3个基地先通医药的官网自述，和它没说出口的部分 ──── 2026.11.03 导语：这一篇不做评价，只做整理。所有信息取自先通医药官网（sinotau.com）的「关于我们」「研发创新」「新闻动态」三个栏目，检索日期2026年11月3日；官网没有写的内容，一律标注「官网未披露」，不用外部资料补充。文末的「观察」部分基于官网事实推断，已单独标出，与事实分开看。核心观点： ·定位　中国创新放射性药物领域的领先企业，专注放射性药物的研发创新及落地应用 ·规模　600余名员工、120项注册专利、2020年4月以来募资近30亿元 ·管线　12条在研管线覆盖三大领域，肿瘤占9条，其中前列腺癌独占4条 01｜定位与时间起点官网「关于我们」的表述是：先通医药是中国创新放射性药物领域的领先企业，专注于放射性药物的研发创新及落地应用以改善患者的健康水平。时间起点写得很明确：2014年正式开展新一代放射性药物的研发。总部位于北京，在上海设有研发中心，在江苏、广东、四川建设有现代化放射性药物生产基地；同时在美国设有分支机构。资本侧，官网给出的口径是：2020年4月至今，已成功募资近30亿元人民币。更早的融资轮次、股东结构、估值与持股比例，官网未披露。把这三个事实按顺序读，能读出一条很典型的路径：先有研发起点（2014），再有资本加速（2020年起），然后才是产能铺开（江苏、广东、四川三地）。核药公司的扩张顺序几乎都是这个次序——先有分子，再有钱，最后才有靠近医院的工厂。 02｜八个数字，和一处口径差异官网「关于我们」页面用八个数字概括公司：12年放射性药物研发经验、3大疾病领域、12条在研管线、1款已上市创新核药、2个研发中心、3个生产基地、600余名员工、120项注册专利。需要说明一处口径差异：官网首页展示的是「8年研发经验、2大疾病领域、8条在研管线、1个研发中心、2个生产基地、473余名员工、81余项注册专利」，与「关于我们」页的版本不一致。本文采用「关于我们」页的数据，首页数字或为未同步更新——这一点官网未作说明。口径不一致本身值得记录。对求职者，看官网数字时最好对一下两个页面，取更保守的一侧；对合作方，说明这家公司的对外信息更新还没形成统一机制，尽调时要多问一句时点。财务数据（营收、净利润、亏损额）、产品销售收入结构、各基地设计产能与投产时间，官网均未披露。 03｜管线：12 条，三个领域的分布很不平均官网「研发创新」页把管线按疾病领域分成三块，并区分诊断与治疗两个方向。心血管是XTR003、XTR004；神经退行性疾病是XTR006；其余9条全部落在肿瘤。把肿瘤那一块单拎出来看，其中4条（XTR010、XTR020、XTR021、XTR022）指向前列腺癌，且覆盖从诊断到不同治疗阶段的完整序列。这是典型的「单病种纵深」打法——不追管线数量，追在同一个适应症里把诊断、治疗、后线全都占住。这种打法的好处是复用：同一套核素供应、同一批核医学科关系、同一条注册路径，可以在四款产品上反复使用。代价是集中度——前列腺癌的竞争一旦恶化，四条线会同时承压。已上市的那一款是欧韦宁®（氟[18F]贝他苯注射液），2023年9月15日获国家药监局批准，官网称其为「国内首个」Aβ-PET显像剂。一款诊断药先落地，符合核药公司「诊断开路」的常规顺序。官网列出的 12 条管线（按疾病领域归并）代号适应症 / 领域 XTR003 心肌活力 / 代谢检测 XTR004 心肌缺血检测 XTR006 阿尔茨海默病 XTR008 G1/G2 胃肠胰神经内分泌肿瘤 XTR015 神经内分泌肿瘤 XTR024 SSTR 治疗失败的 GEP-NETs、G3 NET/NEC、广泛期小细胞肺癌、乳腺癌 XTR010 / 020 / 021 / 022 去势抵抗性前列腺癌等前列腺癌序列 XTR012 前列腺癌骨转移 XTR025 胶质母细胞瘤官网按诊断 / 治疗两个方向分列，但未逐条标注每款归属，故此处不填方向列；研发阶段以官网图形进度条呈现，未给出期别文字说明。 04｜技术栈、人才，与一段标注清楚的观察12年、12条管线、3个基地：先通医药的官网自述，和它没说出口的部分顺着四个要素往下推（以下为本文观察，非官网表述）：螯合物决定核素能不能稳定偶联，连接子决定体内稳定性与药代，核素决定杀伤半径与半衰期，靶向分子决定特异性。四者缺一，分子就成不了药。这也解释了为什么核药团队里放射化学与药学的位置不可替代——它们分别管住了第一、二项。 2026年官网记录的节点很密集：6月1日XTR022（[225Ac]Ac-XT381）的临床数据在ASCO亮相；7月1日XTR008启动新适应症III期；7月2日XTR021的临床试验申请获药监局批准；8月14日天津基地环评第二次公示；8月18日合作方Lantheus的Tau PET示踪剂获FDA批准。产品、临床、产能三条线在同一年推进，说明这家公司正处在「从研发型转向生产型」的过渡段。岗位编制、团队结构、招聘方向与薪酬体系，官网未披露。港股上市进程（10月28日通过港交所聆讯）不在官网信息范围内，以港交所披露为准。最后提醒一句读法：官网是一家公司自己写的自我介绍，它天然会突出强项、略过短板。本文只做整理与对照，不替它回答「好不好」。下一篇档案换一家公司，同样的读法。需要跟踪的节点： ①　下一期档案：晶核生物（bivisionpharma.com），同样只取官网信息 ②　官网口径差异（首页 vs「关于我们」）待公司更新后复核 ③　天津基地环评公示后的建设进度，官网「新闻动态」未见后续披露风险提示：本文全部信息取自先通医药官网公开页面（检索日期2026年11月3日），不含外部资料与推测；官网未披露的内容已逐条标注；文中「观察」段落为基于官网事实的推断，已单独标明。本文不构成投资建议，也不构成任何产品推荐。数据来源 1.先通医药官网：《关于我们》（定位、时间起点、八个数字、募资口径），sinotau.com/about/，检索2026-11-03 2.先通医药官网：《研发创新》管线页（三领域、诊断／治疗分向），sinotau.com/innovating/，检索2026-11-03 3.先通医药官网：首页（数字概览与新闻摘要，与「关于我们」存在口径差异），sinotau.com，检索2026-11-03 4.先通医药官网：《新闻动态》（带日期的节点），sinotau.com/category/news/，检索2026-11-03 5.本文标注说明：文中「官网未披露」指检索当日上述页面未见对应内容，不代表公司实际不存在该信息 □　推荐阅读 ▶四件事，四段链条：核药这一周动的不是分子，是分子之外的三件事 ▶百利天恒：双抗ADC封神之后，一家千亿市值药企的核药第二曲线 ▶港股核药第一股冲刺：先通过聆讯，XTR008 下月见分晓 ▶核药公司图鉴｜恒瑞医药：制药一哥的核药"精准突击"——4款核药进管线，HRS-4357冲刺III期 ▶核药公司图鉴｜恒瑞医药：制药一哥的核药"精准突击"——4款核药进管线，HRS-4357冲刺III期今天的内容对你有帮助吗？点赞 👍　·　在看 👀　·　转发 ➡️ 下一篇核药公司档案想看哪一家？晶核生物、东诚药业、中国同辐，还是你想了解的那个名字，评论区告诉我。 👇 点击下方关注我们免责声明：本文基于公开信息整理撰写，仅供行业交流与信息参考，不构成任何投资建议、医疗建议或商业决策依据。文中涉及的公司信息、临床数据及融资动态均来源于公开报道，如有疏漏或信息更新，请以官方披露为准。素材图片来源网络，如有侵权请联系删除。欢迎转发分享，转载请注明出处。 — END —

放射疗法

2026-10-26

·精准核医润道

核药产业新闻荟萃｜2026.10.24

点击蓝字关注我们本期汇集14条资讯，涵盖²¹²Pb、²²⁵Ac及¹⁷⁷Lu靶向治疗的早期临床证据，PSMA与HER2分子影像进展、PET定量和术中应用、30 MeV加速器与医用同位素产能建设，并关注国内辐射安全监管、基地数智运维及PET筛查价值。 1.AdvanCell公布²¹²Pb-PSMA药物ADVC001更新数据，Ⅰ期推荐剂量组PSA50缓解率80% 【澳大利亚／美国讯】10月23日，AdvanCell在ESMO 2026披露靶向PSMA的²¹²Pb标记α治疗药物ADVC001（TheraPb研究，NCT05720130）Ⅰ期延长随访结果。研究共纳入22例转移性雄激素通路调节治疗耐药前列腺癌患者，考察60至200 MBq、给药间隔1至6周等不同方案，最多给药6次。截至10月5日，中位随访14.1个月，未发现新的安全性信号。在推荐Ⅱ期剂量160 MBq和200 MBq相关队列中，公司报告PSA下降至少50%的患者比例为80%；对具有RECIST可测量靶病灶的5例患者，独立影像评审确认客观缓解5例（5/5）。该剂量组中位影像学无进展生存期为11.2个月。应注意，100%的客观缓解率仅来自5例可评估患者，并非全部22名入组者的缓解率。 Ⅱ期扩展研究正在评估160和200 MBq及诱导、维持和按疗效调整的给药策略，计划延伸至最多12次给药，并纳入不同激素治疗敏感状态的患者。现有疗效属于早期、非随机试验观察，尚不能与既有¹⁷⁷Lu-PSMA疗法直接比较；后续需要明确剂量、给药频率、累积毒性与持久获益之间的关系。 2. 核舟医药公布SSTR2拮抗剂首次人体显像，²²⁵Ac治疗优势仍停留在动物阶段【上海／维也纳讯】10月21日，AlphaGen Therapeutics公布⁶⁸Ga-AG1001的首次人体PET/CT显像结果。研究纳入7例SSTR2表达肿瘤患者，覆盖胰腺及直肠神经内分泌肿瘤、嗜铬细胞瘤、副神经节瘤和小细胞肺癌；在注射后10、30、60和180分钟采集影像，以评估肿瘤摄取、清除特征、初步安全性与剂量学。 AG1001属于生长抑素受体2型拮抗剂。公司报告其肿瘤与背景组织对比度较好、病灶滞留持续，肿瘤／肾脏摄取比随时间提高。另一项独立的临床前研究显示，²²⁵Ac-AG1001在所采用的肿瘤模型中，单次给药较²²⁵Ac-DOTATATE表现出更强且更持久的抗肿瘤活性；公开材料未提供足够的动物样本量、给药活度及完整效应数值以独立评估差距。目前进入人体的是⁶⁸Ga显像剂，并非²²⁵Ac治疗药物，不能将动物疗效转换成临床客观缓解率。SSTR2拮抗剂可识别的受体结合位点可能有别于激动剂，但疗效判断仍需综合肿瘤吸收剂量、肾脏和骨髓暴露及²²⁵Ac子体分布。公司尚未披露²²⁵Ac-AG1001人体治疗结果或商业化核素供应安排。 3. Akiram首次披露CD44v6靶向¹⁷⁷Lu-AKIR001人体数据，8例患者未见剂量限制性毒性【瑞典／维也纳讯】10月19日，Akiram Therapeutics在EANM 2026公布¹⁷⁷Lu-AKIR001首次人体Ⅰ期试验进展。该药物靶向CD44v6，入组对象为标准治疗选择耗尽、不可切除或转移性的CD44v6阳性实体瘤患者。报道时已有8例接受治疗，其中4例完成重复给药，尚未观察到剂量限制性毒性，治疗相关不良事件均为1至2级。定量影像显示，¹⁷⁷Lu-AKIR001在肿瘤内具有持续滞留，同时从血液和部分正常组织清除。公司报告，免疫组化（IHC）显示CD44v6表达较低的患者，其肿瘤吸收剂量也较低。这一关联为治疗前通过组织检测筛选患者、建立靶点表达与剂量关系提供了初步依据。目前公开结果主要涉及可行性、安全性与体内分布，尚不足以评估客观缓解率或生存获益。IHC表达、显像摄取与治疗剂量的对应关系需要在更大人群中校验；不同肿瘤组织的表达差异也可能影响同一核药跨癌种开发时的患者选择标准。 4. Affibody展示HER2放射性配体治疗进展，¹⁷⁷Lu、⁶⁸Ga及¹⁶¹Tb多路径同步推进【瑞典／维也纳讯】10月19日，Affibody在EANM 2026提交10项研究展示，其中包括¹⁷⁷Lu标记HER2靶向药物ABY-271用于HER2阳性转移性乳腺癌的首次人体Ⅰ期试验安全性及生物分布资料（EP-0981）。本次新闻稿未给出具体入组人数、毒性发生率、器官吸收剂量或客观缓解率。其余研究涉及⁶⁸Ga标记HER2显像剂tezatabep matraxetan（ABY-025）：在晚期胃食管腺癌中观察不同病灶间HER2表达差异，并设计HER2-Ex前瞻性开放标签研究，探索PET结果能否预测转移性乳腺癌患者对HER2抗体偶联药物的治疗应答。此外，团队还报告¹⁶¹Tb与¹⁷⁷Lu在HER2亲和体预靶向策略中的临床前比较，以及B7-H3、²²⁵Ac预靶向等相关工作。这条管线把靶点表达成像、治疗性核素递送与患者筛选放在同一研发框架下，值得关注的是HER2病灶内及病灶间异质性。由于新闻来源仅罗列会议研究项目，当前不能据此断言ABY-271已证实有效，或¹⁶¹Tb策略优于¹⁷⁷Lu；仍须等待完整临床数据及相应剂量学报告。 5. Posluma与Pylarify头对头PSMA PET比较：检出率45.5%对27.3%，尚不能判定诊断优越性【美国讯】据对BED-PSMA-411研究（NCT06604442）的报道，在前列腺根治性切除术后、PSA不高于0.5 ng/mL的疑似生化复发患者中，研究人员开展同一患者的两种¹⁸F-PSMA PET对照。每位受试者先接受Pylarify（¹⁸F-piflufolastat）检查，再于1至10天后在同一扫描设备上接受Posluma（¹⁸F-flotufolastat）检查，图像由盲态独立读片者评估。研究报告Posluma总体可疑病灶检出率为45.5%，Pylarify为27.3%；前列腺床检出率分别为18.2%与10.9%，盆腔外为21.8%与7.3%，盆腔淋巴结为16.4%与14.5%。在PSA不高于0.2 ng/mL的21例亚组中，两药检出率分别为52.4%与38.1%。相关结果在2026年2月发表于《European Journal of Nuclear Medicine and Molecular Imaging》，并于9月ASTRO大会补充亚组分析。研究主要终点是比较膀胱尿液放射性，而不是证明肿瘤诊断准确性优越；病灶检出率属次要分析。Posluma的较低膀胱背景可能有利于观察邻近尿路的小病灶，但本研究样本有限，检查顺序未随机化，且阳性病灶没有逐一通过独立标准确认。新增阳性影像是否改变治疗决策、改善结局，仍需要专门验证。 6.NRG用PET追踪实验药物入脑分布，推动核医学进入新药剂量选择环节【英国讯】10月22日，NRG Therapeutics启动NRG5051-102人体PET生物分布研究，在伦敦健康志愿者中使用放射性标记的NRG5051测量药物进入脑组织的程度。NRG5051是一款口服小分子候选药物，拟通过影响线粒体通透性转换孔相关通路，开发用于肌萎缩侧索硬化症（ALS）和帕金森病。试验将结合血浆药物动力学与PET数据，估计脑实质和血浆间的分布关系，为后续给药剂量选择提供依据。该研究与2026年1月开始的NRG5051-101首次人体Ⅰ期安全性及药代试验互为补充。公司计划2027年启动ALS患者Ⅱ期概念验证研究，但报道时尚未公布PET研究的使用核素、受试者数量、具体结果或完成时间。这一设计展示了放射性标记药物作为新药研发定量工具的用途：血药浓度并不能直接回答有效成分是否到达脑组织。PET所测为药物相关放射性，仍需处理代谢物、血管内信号和游离药物比例等问题；证实入脑暴露也不等于已证实靶点结合、神经保护或临床疗效。 7.迈阿密Sylvester肿瘤中心完成首例PET/CT引导消融，将代谢影像带入术中【美国迈阿密讯】10月23日，迈阿密大学Sylvester综合癌症中心完成院内首例PET/CT引导的肿瘤消融操作，由介入放射学团队将放射性示踪剂摄取提供的代谢信息，与CT解剖定位共同用于术中靶区确认及治疗决策。中心未公开该病例的癌种、所用示踪剂、消融方式和疗效结果。术中PET/CT的价值在于弥补部分治疗后、瘢痕或复杂局部解剖下仅靠形态影像定位病灶的不足。报道回顾既往研究：23例患者的29处FDG高摄取肿瘤采用分次给予示踪剂方案，在消融前后进行PET评估；其中28处治疗后未见残留FDG活性，另1处可疑摄取经即时活检证实存在活肿瘤，随即补充治疗。中位155天随访时，最初术后PET阴性的病灶中仍有2处出现局部复发。既往结果说明术中代谢成像可能改变即时处置，但尚不能证明优于常规CT或超声引导消融，更不能用一次阴性PET确认局部根治。实际推广还要解决示踪剂给药时机、术中成像运动与配准、人员防护以及残留摄取的判读标准。 8.Claritas拟控股西班牙Qubiotech，补齐肿瘤与神经系统PET定量软件布局【美国／西班牙讯】Claritas集团于10月22日与西班牙Qubiotech Health Intelligence签署拟收购其多数股权的条款意向文件，计划将旗下PET图像增强与肿瘤定量技术，和Qubiotech的神经影像分析平台neuroCloud整合。双方于2025年5月已建立商业合作，此次为进一步的潜在股权交易，并非完成交割。拟整合的软件包括用于PET、PET/CT及PET/MRI降噪和图像增强的iPET，用于自动分割感兴趣区、计算标准摄取值和病灶体积的iPETcertum，以及分析脑PET、SPECT和MRI数据的neuroCloud。后者覆盖脑区代谢、淀粉样蛋白负荷和多巴胺转运体等指标，有助于长期随访及跨设备成像结果的量化评估。核药临床试验和治疗随访日益依赖可重复的定量指标，软件一致性会影响不同中心间的数据可比性。但图像降噪效果不能自动等同于SUV准确性提升，算法的分割偏差、跨设备适配及验证证据仍是关键。此次收购尚未披露交易金额、确切持股比例或预计完成日期。 9.玖谊源发布30 MeV回旋加速器LB-30，瞄准多核素研发与生产【中国／国际讯】10月21日，中国设备制造商Longevous Beamtech（LBT）推出LB-30系列30 MeV医用回旋加速器，在原有7、11和20 MeV产品基础上扩充更高能段。公司介绍，平台支持可变能量束流引出、多粒子束及不同靶站配置，面向医院、研发机构和专业医用同位素生产商。公司配套高电流固体靶、气体靶、液体靶及正离子内部靶等。公开设备资料列出富集⁷⁰Zn靶材制备⁶⁷Cu、以²²⁶Ra靶材制备²²⁵Ac、用²⁰⁵Tl相关路线制备²⁰³Pb，以及⁶⁴Cu、⁸⁹Zr、⁴⁴Sc和²¹¹At等潜在核素生产方案；其中固体靶站宣称可兼容最高600 μA的H⁻束流，²¹¹At相关正离子靶站列有最高50 μA等效氦离子电流的设计参数。相关参数属于设备与靶站标称能力。对拟兼顾诊断、治疗核素的基地，可调能量与多靶型有助于匹配不同核反应的产额、杂质控制和靶材成本。但能量上限不等于可商业生产全部核素，实际仍取决于靶材供给、束流稳定性、靶后处理、核纯度与质量放行。报道时公司未披露LB-30首个客户、装机时间或经独立验证的产率。 10.Niowave追加逾8500万美元扩产²²⁵Ac，2028年拟投用第二生产设施【美国密歇根讯】10月20日，Niowave位于兰辛地区的第二座医用同位素生产设施AP2正在建设，美国劳工部门负责人赴现场考察。项目资本投入超过8500万美元，新设施面积约8万平方英尺，计划2028年投入运营，可容纳最多6台新增直线加速器，并预计新增至少73个技术及制造岗位。 Niowave现有²²⁵Ac生产采取超导电子直线加速器与²²⁶Ra靶材相关的光核反应路线，先生成²²⁵Ra再衰变取得²²⁵Ac，随后进行分离纯化。新增产能涉及加速器、放射化学实验室、洁净生产及仓储设施。报道还提及企业已与多家核药公司形成长期供应安排，并探索²²⁶Ra原料的纯化回收合作。企业扩大核素供应的约束不止于新增加速器台数，还包括靶材来源、分离收率、设施确认、质量管理和人员资质。73个新增岗位的计划反映放射化学、加速器维护与辐射防护的复合人才需求；报道没有披露新厂投运初期的实测²²⁵Ac产量或每台加速器的详细投产时间表。 11.中广核技亮相EANM 2026，集中展示⁶⁸Ge、锗镓发生器及多核素供应方案【中国／奥地利讯】10月23日，中广核技参加10月17日至21日在维也纳举行的第39届欧洲核医学协会年会，展示中广核同位素（绵阳）科技有限公司的系列医用同位素产品，包括中广核和嘉品牌⁶⁸Ge溶液、锗镓发生器及自动淋洗装置，并介绍¹⁸O、⁶⁴Cu、⁸⁹Zr和¹²³I等产品。现场采用发生器及配套设备实物展示，交流重点涉及⁶⁸Ge与发生器的产能保障、国际市场引入途径、长期供货及联合开发可能性。报道称，欧洲、亚洲和北美合作方与企业讨论区域供应和合作方案，但未披露实际合同金额、出口数量或获得境外市场准入的具体证据。发生器产品的国际交付需要同时满足母体核素质量、子体洗脱性能、杂质控制、装置稳定性和使用端操作要求。参展与合作意向有助于建立商业渠道，却不代表已形成稳定跨境供货；后续更值得关注认证注册路径、订单兑现、实物批次质量及售后服务能力。 12.中核秦同构建同位素基地IMS平台，6799台设备实行一台一档【浙江讯】10月22日，中核秦山同位素有限公司围绕同位素生产基地建立一体化智慧生产信息管理平台（IMS），将6799台设备统一编码并建立全生命周期档案，关联设备台账、维保计划、维修工单及备件管理，推进由计划性维修向状态监测和预兆性维护演进。平台把工作申请、审批许可及现场执行纳入线上流程，同时接入生产与安防监控视频，结合5G专网、人工智能和大数据开展火情及高风险区域行为识别。巡检体系采用NFC签到、高精度地图、智能手环与电子围栏；钴-60生产线的智能辅助决策功能接入DCS及电气监测数据，将设备故障判断经验转换成规则。这类系统的价值是把设备可靠性、作业许可、风险识别和维护证据串成可追溯记录链，而不是简单增加数字化看板。原报道没有披露系统运行前后的故障率、停机时长、辐射事件发生率或已节约成本的精确数据，因此相关成效目前主要属于企业实践介绍，尚不能量化推广后的投资回报。 13.国家核安全局西南监督站开展示范性监督，重点检查热室、靶件与三废【四川讯】10月22日，生态环境部（国家核安全局）西南核与辐射安全监督站联合有关监管技术机构和成都理工大学，组织辖区企业参与放射性药物及医用同位素生产示范性监督，推动以风险为导向的研究式监督方法用于核药研发、中试与规模化生产场景。本次活动提前梳理工艺流程，围绕热室及手套箱操作、靶件处理、放射性物料转运和放射性三废处置等环节编制风险清单及检查细则，并就核技术利用项目重大变动、清洁解控等企业关注问题进行现场交流。通过企业观摩、监管答疑和专家参与，尝试把单点检查转化为行业共同学习的示范场景。对核药工厂而言，这提示辐射安全管理要落实到可执行的岗位步骤和异常处置，而不能停留于设施设计或许可证文本。热室污染控制、跨区域转运、废物分类与暂存、变更管理等事项需形成完整记录。此次报道是监管活动介绍，并非宣告新的全国强制标准已经发布。 14.EANM讨论PET能否用于更早的疾病筛查，专家警惕假阳性与过度诊断【奥地利维也纳讯】10月20日，欧洲核医学大会全体会议讨论PET能否在症状出现之前发现癌症、心血管疾病和阿尔茨海默病。欧洲核医学协会主席Paola Anna Erba提出需审视更早发现疾病能否真正改善健康结局，围绕核医学由症状后诊断向高风险人群早期干预延伸的临床证据展开讨论。德国埃森大学医院Ken Herrmann认为，目前尚不适宜将¹⁸F-FDG PET推广为无症状普通人群的癌症普筛方法。报道援引韩国相关研究称，部分筛查研究中的可疑PET结果约四分之三最终属假阳性。会议讨论了先用血液或唾液标志物筛选高危人群、再进行PET检查的分层路径；在阿尔茨海默病场景中，也提及用血浆磷酸化tau 217协助判断淀粉样蛋白PET检查需求。 PET提供分子层面的敏感信号，但扩大检查覆盖面可能增加假阳性、后续有创检查、过度诊断和资源消耗。临床价值应以人群风险分层、后续干预可用性及真实预后改善来衡量；单凭检出时间提前或检出率提高，不足以证明人群筛查的净获益。往期回顾 01 ｜【黄钢】2026欧洲核医学大会启示：核医学的新征程，重在临床实效，而非靶点炫技 02 ｜放射性药品生产许可证办理指南：申请条件、ABC分类与审批流程 03 ｜核药产业新闻荟萃｜2026.10.08—10.20 04 ｜基于风险分层的医疗机构放射性药品监管路径：欧美经验及其启示 About us 找到我们 - 微信公众号 - 搜索 “精准核医润道”

2026-09-22

·PRNewswire

Blue Earth Diagnostics to Present New Research Advancing Precision Molecular Imaging at ASTRO 2026

BOSTON, Sept. 22, 2026 /PRNewswire/ -- Blue Earth Diagnostics, part of the Bracco Group and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced new research examining how precision molecular imaging may provide clinically meaningful insights in cancer care when conventional measures or imaging alone may leave uncertainty about the location or extent of disease. The data, spanning recurrent prostate cancer and brain metastases, will be presented at the upcoming American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting, September 26–30, in Boston, MA. The presentations highlight two distinct clinical settings in which clinicians may face uncertainty. In recurrent prostate cancer, rising prostate-specific antigen (PSA) levels may indicate cancer has returned without showing where it is located. The first presentation showcases an analysis from the first intra-patient, head-to-head comparator study of POSLUMA® (flotufolastat F 18) and piflufolastat F 18, examining detection rates in men with biochemical recurrence. For patients with brain metastases, the second study evaluated fluciclovine F 18 PET/CT alongside magnetic resonance imaging (MRI) following surgery, when post-operative changes can make it difficult to distinguish treatment-related changes from tumor necrosis or pseudoprogression. Previously presented results from the head-to-head study, including data shared at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, showed significantly lower urinary radioactivity with POSLUMA compared with piflufolastat F 18. Lower urinary activity may mean less interference when looking for recurrent disease, particularly at very low PSA levels. At ASTRO 2026, the new analysis explores how clinical factors may influence detection with POSLUMA and piflufolastat F 18 in men with biochemical recurrence and low PSA levels (≤0.5 ng/mL) following radical prostatectomy. Factors include baseline PSA level, time since radical prostatectomy, initial disease stage and International Society of Urological Pathology (ISUP) Grade Group. "Biochemical recurrence after radical prostatectomy presents an important clinical challenge because a rising PSA level can signal recurrent disease without identifying where it is located," said Jack R. Andrews, M.D., Urologic Oncologist and Assistant Professor of Urology, Mayo Clinic. "This first head-to-head PSMA PET trial allows us to compare two PSMA PET imaging agents in the same patients and better understand how clinical factors may affect detection rates, particularly at low PSA levels. These insights can help inform how molecular imaging is used in the evaluation of patients with biochemically recurrent prostate cancer." The brain metastases presentation draws from a prospective, single-institution trial evaluating fluciclovine F 18 PET/CT in adults undergoing resection followed by post-operative fractionated stereotactic radiosurgery. The study examined whether PET imaging alongside MRI can provide additional information to assess the extent of resection, refine target volume delineation – defining the area to be treated with radiation – and monitor for signs of recurrence over time. "In multidisciplinary cancer care, connecting the right imaging insights with the treatment decisions that follow is critical," said Marco Campione, President and CEO of Blue Earth Diagnostics. "Our presence at ASTRO 2026 reflects our continued commitment to advancing the field of precision molecular imaging through focused science and clinical research. From identifying suspected recurrent prostate cancer when PSA levels are low to exploring how PET imaging may help better define and monitor brain metastases following surgery, this research builds on our experience in molecular imaging while helping expand what these technologies can reveal to inform patient care." Blue Earth Diagnostics also invites ASTRO attendees to the Satellite Symposium, " Precision in PSMA: Why Agent Selection Matters More Than Eve r," on Sunday, September 27, from 12:00 to 1:00 p.m. ET, in Theater 2 on the ASTRO Exhibit Floor. This program will examine the evolving role of PSMA radiopharmaceutical imaging agents and their potential impact on patient care. Experts in nuclear medicine and urology, including Sean Collins, MD, PhD, Professor of Radiation Oncology at the University of South Florida, will review emerging clinical evidence, including recent head-to-head study data, and discuss implications for precision oncology. Attendees can also visit Blue Earth Diagnostics at Booth #2147. For complete details on the sessions and a list of scientific presentations, please refer to the ASTRO 2026 Annual Meeting online program . POSLUMA ® (flotufolastat F 18) Date: Tuesday, September 29, 2026 Title: Impact of Clinical Factors on 18 F-Piflufolastat and 18 F-Flotufolastat Detection Rates in Patients with Recurrent Prostate Cancer Post-prostatectomy: Results from an Intra-patient Head-to-head Study Presenter: Alain Chaglassian, MD, MPH, Blue Earth Diagnostics Inc., Needham, MA, USA Session Type: Poster presentation Session Time: 2:15 – 3:30 PM ET Abstract ID: 3320 Date: Wednesday, September 30, 2026 Title: A Prospective Single-Arm Study of POSLUMA PET in Very Low Prostate-Specific Antigen Recurrence Following Prostatectomy Presenter: Jacob Hogan, MD, Harvard Radiation Oncology Program, Boston, MA, USA Session Type: Poster presentation Session Time: 8:30 – 8:35 AM ET Abstract ID: 1222 Axumin ® (fluciclovine F 18) Date: Sunday, September 27, 2026 Title: 18F Fluciclovine PET in Postoperative Target Delineation and Recurrence Detection in Resected Brain Metastasis: Pre-Planned Analysis of a Prospective Trial Presenter: Hanan N. Hassan, MD, Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL, USA Session Type: Poster presentation Session Time: 3:00 – 4:00 PM ET Abstract ID: 2085 About Bracco Bracco Group, founded in 1927, is a global leader in diagnostic imaging, committed to advancing healthcare and improving people's lives by shaping the future of prevention and precision medicine. The company operates in the healthcare sector across more than 100 countries with a workforce of over 4,000 employees and consolidated annual revenues of approximately €2 billion, 88% generated by international markets. With a strong commitment to innovation - investing around 9% of its reference turnover in Research & Development - Bracco develops and provides a broad portfolio of pharmaceutical products for diagnostic imaging, including contrast agents for X-ray, Computed Tomography (CT), and Magnetic Resonance Imaging (MRI), as well as microbubbles for Contrast Enhanced Ultrasound (CEUS), and Molecular Imaging through radioactive tracers and novel PET imaging agents, alongside AI-based solutions. It is also a global market leader in advanced contrast management technologies for cardiovascular angiography and radiology imaging. Discover more at . About Blue Earth Diagnostics Blue Earth Diagnostics, a part of the Bracco Group, is a global company advancing precision molecular imaging to support timely decisions and better patient outcomes. Founded in 2014, we work closely with clinicians and collaborators, bringing deep expertise to the development and delivery of positron emission tomography (PET) radiopharmaceuticals. Our growing portfolio helps uncover disease sooner and guide treatment choices across multiple disease states, including oncology and cardiology. Backed by a dedicated team, we deliver clear answers when decisions matter most. For more information, please visit: . POSLUMA® and Axumin® are registered trademarks of Blue Earth Diagnostics. U.S. Indication and Important Safety Information About POSLUMA INDICATION POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or . Full POSLUMA prescribing information is available at . U.S. Indication and Important Safety Information About Axumin INDICATION Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment. IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended. Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available. Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers. Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia. To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or . Please see Axumin full Prescribing Information . Contacts: For Blue Earth Diagnostics Monica Planinsek Corporate Communications Manager [email protected] (M) (207) 838-3863 Media Shannon Moore [email protected] (M) (714) 348-4838 SOURCE Blue Earth Diagnostics 21% more press release views with Request a Demo

放射疗法临床研究

100 项与氟[18F]妥司特相关的药物交易

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适应症	国家/地区	公司	日期
复发性前列腺癌	韩国	DuChemBIO Co., Ltd.	2025-07-22
前列腺癌	美国	Blue Earth Diagnostics Ltd.	2023-05-25

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适应症	最高研发状态	国家/地区	公司	日期
前列腺腺癌	临床3期	美国	Blue Earth Diagnostics Ltd.	2020-03-02
前列腺腺癌	临床3期	芬兰	Blue Earth Diagnostics Ltd.	2020-03-02
前列腺腺癌	临床3期	德国	Blue Earth Diagnostics Ltd.	2020-03-02
前列腺腺癌	临床3期	荷兰	Blue Earth Diagnostics Ltd.	2020-03-02
非转移性前列腺癌	临床2期	美国	Blue Earth Diagnostics Ltd.	2023-04-27
转移性去势抵抗性前列腺癌	临床2期	美国	Blue Earth Therapeutics Ltd.	2022-07-20
转移性去势抵抗性前列腺癌	临床2期	比利时	Blue Earth Therapeutics Ltd.	2022-07-20
转移性去势抵抗性前列腺癌	临床2期	德国	Blue Earth Therapeutics Ltd.	2022-07-20
转移性去势抵抗性前列腺癌	临床2期	荷兰	Blue Earth Therapeutics Ltd.	2022-07-20
转移性去势抵抗性前列腺癌	临床2期	英国	Blue Earth Therapeutics Ltd.	2022-07-20

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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


NCT07115277 (EANM2026)	临床3期	非转移性前列腺癌	121	XTR020 PET/CT	餘糧襯繭積鏇選廠鹹簾(窪醖壓夢願獵積網選襯) = 獵簾蓋繭醖餘築製範網壓艱簾膚鏇顧積遞鹹簾 (築選鏇鹹選願淵夢鹹醖, 38.1 ~ 72.1) 更多	积极	2026-10-17
NCT06604442 (EANM2026)	临床4期	前列腺癌	55	18F-Piflufolastat	鑰鏇齋夢積簾壓顧憲獵(窪衊壓築淵範選衊壓窪) = 網壓網網遞夢醖壓膚壓範憲夢齋鑰憲膚醖鬱壓 (鏇艱鑰獵遞襯壓膚憲繭, 1.70 ~ 3.81) 更多	积极	2026-10-17
				18F-Flotufolastat	鬱願鹹膚繭壓簾餘遞鏇(鹽鹽夢齋壓願膚鹽襯襯) = 壓廠製鹹繭憲築繭鬱夢製夢願夢製襯獵鏇構餘 (齋製餘顧蓋範積積製範 )
EANM2026	N/A	前列腺癌 prostate-specific membrane antigen (PSMA)	193	18F-flotufolastat (Radio-guided salvage surgery (RGS))	廠衊膚襯鹹壓構蓋構襯(糧網顧製鹽窪窪觸簾築) = 鏇憲醖餘鑰願遞醖醖願築構糧鑰夢餘壓壓壓夢 (鹽餘憲鏇鹹艱選構範選, 0.16 ~ 8.4) 更多	积极	2026-10-17
				18F-flotufolastat (Salvage external beam radiotherapy (EBRT))	廠衊膚襯鹹壓構蓋構襯(糧網顧製鹽窪窪觸簾築) = 遞鹹網糧築構選夢糧鏇築構糧鑰夢餘壓壓壓夢 (鹽餘憲鏇鹹艱選構範選, 0.14 ~ 20) 更多
NCT06604442 (CTgov)	临床4期	复发性前列腺癌	62	Piflufolastat (18F) (Piflufolastat (18F) PET)	醖範蓋鬱觸簾選遞鏇遞(鬱範願憲鏇繭選鹹簾觸) = 鏇願廠築觸餘積選醖蓋積製壓憲顧製選廠網壓 (鑰齋顧網顧艱膚窪製鹹, 顧齋淵製願鬱廠觸範繭 ~ 衊簾夢鬱襯醖簾鬱衊艱) 更多	-	2026-05-12
				Flotufolastat (18F) (Flotufolastat (18F) PET)	醖範蓋鬱觸簾選遞鏇遞(鬱範願憲鏇繭選鹹簾觸) = 鏇蓋壓衊願鏇觸範願鏇積製壓憲顧製選廠網壓 (鑰齋顧網顧艱膚窪製鹹, 廠鏇糧鑰鹹遞艱築構襯 ~ 憲網遞鬱製艱範顧鹹齋) 更多
NCT04186845 (SPOTLIGHT, ASCO_GU2026)	临床3期	前列腺癌 Prostate-specific antigen (PSA)	121	18 F-flotufolastat (PSA level <0.5 ng/mL + Prostate Cancer with Biochemical Recurrence)	鹽觸簾範淵築夢積遞鹹(糧廠繭網範獵鏇鹹廠夢) = 獵齋構衊製鹽鑰遞鹹廠構築構遞衊蓋鹹窪廠觸 (襯構膚艱構鑰糧壓淵構 ) 更多	积极	2026-02-26
NCT03995888 (CTgov)	临床1期	前列腺癌 \| 前列腺腺癌	24	rhPSMA-7.3 (18F) Injection	觸餘顧遞醖夢醖鑰襯糧 = 糧顧鹽鑰選獵鏇鏇醖鏇廠醖艱鹹鹽糧願顧構願 (壓鑰壓蓋製襯鬱網淵艱, 蓋醖壓獵範糧廠餘觸製 ~ 鑰膚膚襯繭製夢夢壓顧) 更多	-	2026-02-12
NCT05779943 (CTgov)	临床2期	复发性前列腺癌 \| 非转移性前列腺癌 \| 前列腺腺癌	20	Computed Tomography+F18-rhPSMA-7.3+furosemide	鏇範鹽鹽窪簾顧觸範夢(窪選觸積鹹顧鑰範窪醖) = 遞膚窪構齋鹹鬱築壓簾醖鬱範鏇顧積鬱製餘製 (衊顧積觸鹹艱淵壓鬱鑰, 3.71) 更多	-	2025-10-27
NCT05779943 (Pubmed \| J Nucl Med)	临床2期	前列腺癌	20	18F-flotufolastat (rhPSMA-7.3)furosemideat (rhPSMA-7.3) (With-furosemide PET/CT studies)	範繭鏇窪壓鹹築構觸鹹(遞壓餘觸齋襯簾糧膚範) = 鑰簾鬱願獵簾獵艱襯構蓋蓋願衊夢範壓鏇鏇窪 (襯鹹膚遞衊獵淵衊積鏇, 1.70 ~ 19.80) 更多	积极	2025-02-01
				18F-flotufolastat (rhPSMA-7.3)furosemide(rhPSMA-7.3) (Without-furosemide PET/CT studies)	範繭鏇窪壓鹹築構觸鹹(遞壓餘觸齋襯簾糧膚範) = 鏇餘夢鬱齋網醖窪衊廠蓋蓋願衊夢範壓鏇鏇窪 (襯鹹膚遞衊獵淵衊積鏇, 3.90 ~ 165.4) 更多
NCT04186845 (SPOTLIGHT, Biospace) 人工标引	临床3期	复发性前列腺癌 Prostate specific antigen	119	POSLUMA (PSA < 1 ng/mL)	選構壓構網築鏇壓範製(窪製構遞築選夢窪夢廠) = 遞構鏇獵廠窪餘夢顧淵鏇壓鑰遞壓鑰齋網餘觸 (積艱齋艱齋築壓衊衊網 )	积极	2024-10-01
				POSLUMA (PSA< 0.5 ng/mL)	選構壓構網築鏇壓範製(窪製構遞築選夢窪夢廠) = 壓壓膚繭鏇膚顧鬱窪築鏇壓鑰遞壓鑰齋網餘觸 (積艱齋艱齋築壓衊衊網 )
ASTRO2024	N/A	非转移性前列腺癌	-	F-18 rhPSMA 7.3 PET/MRI	構憲襯願憲齋獵壓壓鑰(獵鹽蓋製淵鏇衊壓窪糧) = 網顧淵鹽構鬱構範鏇蓋鬱糧鹹構餘襯簾選獵顧 (鬱網糧膚網蓋製鹹艱衊 ) 更多	-	2024-10-01