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2026-07-31

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 ; Shore, Neal ; Pathak, Ram A ; 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.

127

项与氟[18F]妥司特相关的新闻（医药）

2026-07-13

·汇佳生物

Blue Earth Therapeutics宣布Ac-225 rhPSMA-10.1 注射液I期临床试验完成首例受试者给药，用于mCRPC治疗

临床阶段放射性药物企业 Blue Earth Therapeutics与伦敦大学学院（UCL）近日联合宣布，启动一项I期临床试验（试验编号 NCT07414940），评估在研α发射型靶向前列腺特异性膜抗原（PSMA）放射性药物 Ac-225 rhPSMA-10.1 注射液，用于临床试验中转移性去势抵抗性前列腺癌（mCRPC）患者。本研究由UCL申办，于伦敦大学学院附属医院开展；Blue Earth Therapeutics 提供研究资金及试验用药物。该I期研究入组既往经治疗后疾病进展、PSMA 表达阳性的转移性去势抵抗性前列腺癌受试者，旨在评估Ac-225 rhPSMA-10.1 注射液的安全性与抗肿瘤活性。研究数据将明确该药物的不良反应特征，为后续临床试验确定给药剂量提供依据。 Ac-225等α发射型放射性核素可在组织内短距离释放高能量射线，对靶向肿瘤细胞造成不可逆 DNA 损伤，同时尽可能减少对周边正常组织的辐射暴露。将 Ac-225 偶联 rhPSMA-10.1 这类 PSMA 靶向分子后，可向前列腺癌病灶精准递送局部辐射，有望为晚期癌症患者提供靶向治疗新方案。 Ac-225 rhPSMA-10.1 注射液是 Blue Earth Therapeutics 肿瘤管线内第二款进入临床阶段的候选药物，其研发依托公司正在推进的Lu-177 rhPSMA-10.1 注射液临床项目（目前处于II期临床阶段）。两条管线同步推进，体现公司依托自研放射性杂合 PSMA 平台，同步布局 α 射线、β 射线两大类放射性配体药物。伦敦大学学院癌症研究所所长 Gert Attard 教授表示：“本项研究是为转移性去势抵抗性前列腺癌男性患者开发更精准治疗方案的关键一步。高特异性 PSMA 靶向载体搭配 α 核素强效、短射程的杀伤特性，有望在实现显著抗肿瘤疗效的同时降低毒副作用。此类早期临床试验至关重要，能够明确药物安全性、优化给药剂量，并指导该类疗法如何融入个体化治疗路径，最终改善患者生存预后。” Blue Earth Therapeutics 首席执行官 David Gauden 博士称：“本次合作I期临床试验顺利启动，是 Blue Earth Therapeutics 及其在研放射性药物管线的重要里程碑。依托我们在 α、β 发射型放射性药物领域积累的临床经验，我们将 rhPSMA 精准靶向能力与Ac-225 的α 射线治疗特性相结合，探索晚期前列腺癌全新治疗方案。在此由衷感谢伦敦大学学院研究团队与参与本试验的患者。” 关于Radiohybrid前列腺特异性膜抗原（rhPSMA）据预测，2025 年美国新发转移性前列腺癌病例共计 50,055 例（含初诊晚期病例与早期肿瘤复发转移病例）。新发转移性前列腺癌患者 5 年生存率仅 40.1%。尽管过去三十年间前列腺癌死亡率持续下降，但患者生存预后仍存在巨大提升空间。关于Radiohybrid前列腺特异性膜抗原（rhPSMA） rhPSMA 全称为 radiohybrid，该类分子包含四大功能结构域： ●前列腺特异性膜抗原靶向配体； ●两组标记基团，可连接诊断核素（如F-18、Ga-68）用于 PET 显像，或连接治疗核素（如 Lu-177、Ac-225）开展放射性配体治疗； ●可修饰连接臂，能够调控药物关键药代动力学参数。 RadiohybridPSMA 技术由德国慕尼黑工业大学研发，可为前列腺癌男性患者提供靶向治疗潜力。2018 年，Blue Earth Diagnostics 自 Scintomics GmbH 获得 rhPSMA 显像技术全球独家权益；2020 年取得其治疗用途全球独家权益，并将治疗相关权益分授权给旗下兄弟公司 Blue Earth Therapeutics。关于 Blue Earth Therapeutics Blue Earth Therapeutics 为临床阶段生物企业，专注研发新一代靶向放射性治疗药物，用于癌症患者治疗，孵化于Bracco 集团体系。2024 年 A 轮融资中，多家外部投资方与博莱科共同完成注资。公司核心团队深耕放射性药物、肿瘤药物全流程开发，兼具生物技术初创企业运营经验，致力于优化现有技术、快速推进重症疾病靶向新药研发，管线现阶段聚焦前列腺癌领域。关于Bracco Bracco Group创立于 1927 年，是全球影像诊断领域龙头企业，致力于推动医疗健康发展，通过引领预防医学与精准医疗革新改善大众健康。集团业务覆盖全球超 100 个国家，员工逾 4000 人，年度合并营收约 20 亿欧元，其中国际市场营收占比 88%。集团高度重视创新研发，研发投入约占基准营收的 9%，产品矩阵覆盖全品类影像诊断药物：X 光、计算机断层扫描（CT）、磁共振（MRI）造影剂，超声增强微泡造影剂；同时布局分子影像赛道，开发放射性示踪剂、新型 PET 显像探针，并配套人工智能诊疗解决方案。此外，集团在心血管造影、放射影像高端造影管理设备领域位居全球市场前列。点击下方阅读原文，了解更多信息往期回顾英国首批患者接受 Blue Earth Therapeutics 研究性放射性药物疗法 ——Lu-177 rhPSMA-10.1 注射液治疗转移性去势抵抗性前列腺癌 Blue Earth Therapeutics评估177Lu rhPSMA-10.1治疗转移性去势抵抗性前列腺癌中的疗效和安全性 Blue Earth Therapeutics公布177Lu rhPSMA-10.1注射液I期临床试验的关键结果汇佳生物专注于转化医学领域的前沿研究及临床转化应用技术，业务涵盖生物标志物和药物靶标技术，新型诊断试剂及治疗药物的研发，相关仪器设备的开发及临床转化技术的应用，实现了产、医、研的融合发展。媒体合作/科研宣传/产品咨询长按二维码，联系我们

2026-07-13

·今日头条

2026上半年国产创新药获批超去年全年，这几款新药有进展

过去一周，国内外的创新药赛道消息不少。数家药企同步公布了在研管线的推进进展——有的拿到了监管批文，有的完成了早期临床的首例患者入组。从研发效率的角度看，一款新药从靶点发现到IND申报，国内企业目前平均比十年前缩短了约两年。背后是审评提速、CRO体系成熟、以及资本端的合力推动。这几家公司的节奏，其实是整个体系效率提升的缩影。再看一个行业侧面的信号。国家药监局最新数据显示，2026年上半年国产新靶点、新机制创新药获批数量已经超过去年全年，国产创新药对外授权交易总额接近1100亿美元。这说明国内创新药的研发节奏确实在加快，对外合作也在持续升温。 STAT3这个靶点有了新数据 Tvardi Therapeutics公布了TTI-109的1期临床结果。这款药是TTI-101的前药版本——目的很简单，就是让口服之后吸收更稳定，身体耐受度更好。从公布的数据看，给药后大约两小时内，TTI-109就能转化为TTI-101，血药浓度能一直维持在抑制STAT3所需的水平之上。药效学方面，在健康受试者身上观察到了靶点结合的迹象，三类主要的STAT3驱动相关免疫细胞——Th17细胞、滤泡辅助性T细胞和B细胞亚群——数量下降了最高60%。 STAT3靶点的逻辑在于它是多条炎症通路的交汇点。能用一个口服小分子把它按住，理论上可以同时调控多条致病通路，比单独阻断某一条上游通路可能更高效。从“难成药靶点”的技术门槛来看，STAT3这类转录因子的口服抑制剂研发本身就有相当的技术挑战。能做到靶点结合并推进到1期读出数据，至少说明分子的设计逻辑初步站住了。 Tvardi下一步计划往皮肤病和胃肠道疾病方向推进。这两个领域确实有不少跟STAT3相关的炎症机制，且目前的口服药物选择不算充裕。结直肠癌领域迎来一款新的双抗 LTZ Therapeutics的LTZ-232拿到了FDA的IND许可，预计今年第四季度启动1期临床。这款药的思路跟传统的PD-1/PD-L1抑制剂不太一样。后者主要是激活T细胞去攻击肿瘤，而LTZ-232调动的是肿瘤相关巨噬细胞，通过双抗设计引导它们去吞噬肿瘤细胞。靶点是EpCAM，一个在多种实体瘤表面高表达的分子。 LTZ选择先做结直肠癌，跟这个癌种的微环境特征有关。结直肠癌的髓系细胞比较丰富，正好是这类药物理论上更适合发挥作用的场景。当然，早期临床能观察到什么样的信号，还得等数据出来再说。前列腺癌放射性药物完成首例给药 Blue Earth Therapeutics的²²⁵Ac rhPSMA-10.1也在1期完成了首例患者给药。这款药用的是锕-225，属于α粒子发射型核素。跟目前已上市的β粒子类放射性药物相比，α粒子的射程更短、能量更高，理论上对周围正常组织的损伤更可控、更局限。这个1期试验由伦敦大学学院医院主导，入组的是既往治疗进展后的PSMA阳性转移性去势抵抗性前列腺癌患者。主要看安全性和耐受性，同时收集一些抗肿瘤活性的初步数据。值得一提的是，这款药采用rhPSMA平台开发——同一个分子既能连接诊断用的同位素进行PET成像，又能连接治疗用的同位素进行治疗，实现诊疗一体化。先做成像确认靶点表达，再进行后续治疗，这个思路在精准治疗领域越来越受到关注。国内多囊肾病领域也有了新动作 Arnatar Therapeutics的ART5拿到了国家药监局的临床试验许可，预计今年第三季度启动健康受试者的1期研究。这款药比较特别。它不是传统的基因沉默型ASO，而是上调型的——目的是恢复多囊蛋白1的表达。常染色体显性多囊肾病主要由PKD1或PKD2基因突变引起，导致多囊蛋白生成不足，进而推动肾囊肿不断形成和肾功能丧失。临床前数据显示，ART5能让PC1表达提高大约两倍，在患者来源的细胞中观察到了囊肿形成减少和细胞增殖下降。如果能顺利进入临床并验证这些效应，对于这个目前主要靠对症支持治疗的疾病来说，意义确实不一样。小结四款药覆盖了口服小分子、双抗、放射性核素、反义寡核苷酸四个技术方向，分布在IND获批、数据读出、首例给药三个不同节点。从上半年整个行业的走向看，多技术路径同时推进的信号值得关注。从产业端看，2026年上半年国内创新药在审批效率和对外授权两个维度都有明显提速。这几家企业的管线推进，不管是拿到FDA批文还是国内许可，都是这个大趋势下的具体体现。如果从“难成药靶点”的技术门槛来观察，STAT3这类转录因子的口服抑制剂研发本身就有相当的技术挑战。能做到靶点结合并推进到1期读出数据，至少说明分子的设计逻辑初步站住了。这些早期临床项目的走向，还需要更多数据来验证。但至少从目前的推进节奏看，国内外的创新药赛道仍然保持了一定的活跃度。一点拙见以上几家企业的管线进度，对行业来说都是常规的研发推进节点。不过能在这个时间窗口看到多个不同技术路线的候选药物同时往前推，本身就是行业活力的体现。尤其是在“难成药靶点”这个方向上，口服小分子抑制剂能做出靶点结合数据，技术门槛本身就说明了一些问题。大家觉得，国内在炎症免疫和肿瘤靶向这两个方向上，哪类新机制更有产业化潜力？欢迎留言聊聊。声明：本文仅医药健康行业知识交流，不构成投资、用药指导或生产操作建议。参考文献 1. Nasdaq. TVRD Stock Rallies 149% So Far This Week: Here's What You Should Know，2026-07-09 2. 网易. 下一代STAT3抑制剂临床试验结果积极；潜在“first-in-class”双抗即将进入临床…… | 一周盘点，2026-07-13 3. Targeted Oncology. First Patient Treated With PSMA-Targeted Actinium-225 Alpha Emitter in mCRPC，2026-07-10 4. Shanghai Securities News. 瑞银证券：中国药企正成为全球创新的关键参与者，2025-10-27 5. The Manila Times. Arnatar Therapeutics Receives China NMPA Clearance to Initiate First-in-Human Study of ART5，2026-07-07 #药企管线进展 #创新药研发 #STAT3抑制剂 #放射性药物

临床申请临床1期

2026-07-13

·PRNewswire

Blue Earth Therapeutics announces first participant dosed in Phase 1 clinical trial investigating Actinium (²²⁵Ac) rhPSMA-10.1 Injection in metastatic castration-resistant prostate cancer

The University College London (UCL) sponsored study evaluates safety, tolerability and radiation dosimetry of an investigational alpha‑emitting PSMA‑targeted radiopharmaceutical therapy, building on Blue Earth Therapeutics' radiohybrid platform. For Media and Investors only OXFORD, England, July 9, 2026 /PRNewswire/ -- Blue Earth Therapeutics, a clinical-stage radiopharmaceutical company and University College London (UCL) today announced initiation of a Phase 1 clinical trial (NCT07414940) evaluating Actinium (225Ac) rhPSMA-10.1 Injection, an investigational alpha‑emitting PSMA‑targeted radiopharmaceutical for the treatment of patients within clinical trials in metastatic castrate‑resistant prostate cancer (mCRPC). The study is sponsored by UCL and is being conducted at UCL Hospital, London. Blue Earth Therapeutics is providing funding and supply of investigational drug product. This Phase 1 study is designed to evaluate the safety and anti-tumour activity of Actinium (225Ac) rhPSMA-10.1 Injection in participants with PSMA‑positive mCRPC whose disease has progressed following prior therapy. Results from the study are expected to characterise the side effects of Actinium (225Ac) rhPSMA-10.1 Injection and to inform dose selection for subsequent research. Alpha-emitting radionuclides such as actinium-225 (225Ac) deliver a high amount of energy over a short distance in tissue, causing irreparable DNA damage to targeted cancer cells whilst aiming to limit exposure to surrounding healthy tissue. When incorporated into a PSMA-targeting molecule such as rhPSMA-10.1, this approach is designed to deliver localised radiation directly to prostate cancer lesions, potentially offering a targeted treatment strategy for patients with advanced cancer. Actinium (225Ac) rhPSMA-10.1 Injection is the second clinical candidate in Blue Earth Therapeutics' oncology pipeline, building on the company's ongoing Lutetium (¹⁷⁷Lu) rhPSMA‑10.1 Injection clinical programme, which is currently in a Phase 2 clinical trial. Together, these programmes reflect the company's work across both alpha‑ and beta‑emitting radiopharmaceutical therapies using its radiohybrid PSMA platform. UCL Cancer Institute director Professor Gert Attard said: "This study is an important step in advancing more precise treatment options for men with metastatic castrate-resistant prostate cancer. The combination of a highly targeted PSMA approach with the potent, short-range effects of an alpha-emitting radionuclide offers a promising strategy to deliver meaningful anti-tumour activity while limiting toxicity. Early-phase trials such as this are essential for determining safety, refining dose and guiding how these therapies can be integrated into personalised treatment pathways to improve outcomes for patients." "Initiation of this collaborative Phase 1 study represents an important milestone for Blue Earth Therapeutics and our investigational radiopharmaceutical therapy pipeline," said Dr David Gauden, Chief Executive Officer of Blue Earth Therapeutics. "Building on our clinical experience in both alpha‑ and beta‑emitting radiopharmaceutical therapies, we are combining the targeting precision of rhPSMA with the alpha‑emitting properties of actinium‑225 to explore a potential treatment approach for patients with advanced prostate cancer. We are very grateful to the team at UCL and to their patients for undertaking this study." About metastatic prostate cancer It has been forecast that in 2025 there would be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).1 Five-year survival for newly diagnosed metastatic prostate cancer is low, 40.1%.2 While death rates from prostate cancer have declined over the past three decades2, there is still considerable room to improve patient outcomes. About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA) rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabelled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. About Blue Earth Therapeutics Blue Earth Therapeutics is a clinical stage company dedicated to advancing next-generation targeted radiotherapeutics to treat patients who have cancer and has been incubated within the Bracco family of companies. Other investors joined with Bracco in a Series A financing round in 2024. With proven management expertise across the spectrum of radiopharmaceutical and oncology drug development, as well as biotechnology start‐up experience, the Company aims to innovate and improve upon current technologies and rapidly advance new targeted therapies for serious diseases. Blue Earth Therapeutics has an emerging pipeline initially focused on prostate cancer. For more information, please visit: . 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 Actinium (225Ac) rhPSMA-10.1 Injection has not received a marketing authorisation in any country or region. Lutetium (177Lu) rhPSMA-10.1 Injection has not received a marketing authorisation in any country or region. References: Gallichio L et al, JNCI J Natl Cancer Inst (2022) 114(11): djac158 SEER 22 database, , last accessed July 2026 Contact: For Blue Earth Therapeutics Harriet Cheshire, Associate Director, Corporate Development and Communications [email protected] UKBET-rh-2600006 | July 2026 SOURCE Blue Earth Therapeutics 21% more press release views with Request a Demo

临床1期临床2期放射疗法

100 项与氟[18F]妥司特相关的药物交易

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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
前列腺癌	美国	Blue Earth Diagnostics Ltd.	2023-05-25

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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
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
复发性前列腺癌	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

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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


NCT06604442 (CTgov)	临床4期	复发性前列腺癌	62	Piflufolastat (18F) (Piflufolastat (18F) PET)	鹽繭繭簾衊網廠網艱醖(襯壓簾廠鹽鏇構襯製鑰) = 艱顧願艱獵醖鑰簾顧蓋鏇蓋鹹齋網鏇鹽遞製鹹 (憲齋壓鬱窪膚艱遞鹹齋, 顧製鏇壓築獵製廠願積 ~ 壓蓋膚壓鹹餘鹽廠夢觸) 更多	-	2026-05-12
NCT06604442 (CTgov)	临床4期	复发性前列腺癌	62	Flotufolastat (18F) (Flotufolastat (18F) PET)	鹽繭繭簾衊網廠網艱醖(襯壓簾廠鹽鏇構襯製鑰) = 範鑰鏇鏇壓淵淵夢衊鑰鏇蓋鹹齋網鏇鹽遞製鹹 (憲齋壓鬱窪膚艱遞鹹齋, 鹽鏇醖鏇網簾選獵選觸 ~ 鑰艱鏇窪艱網鬱襯廠壓) 更多	-	2026-05-12
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)	壓觸糧鹽範網膚鑰顧淵(願獵獵夢築製襯鬱鹽築) = 顧鑰製鏇襯壓顧積襯鹹獵製鬱觸觸獵遞壓衊範 (憲獵願願簾衊壓廠獵築 ) 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	糧鏇製積膚醖醖構選鬱 = 鏇鹽鏇廠積製糧繭餘夢憲壓鏇鏇選簾製製願選 (廠壓繭艱蓋糧餘膚蓋遞, 製衊壓廠網鏇觸夢範鏇 ~ 遞鬱餘簾廠壓廠窪願廠) 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	餘憲衊構鏇構鏇蓋窪獵(願獵顧獵觸築膚製衊鹹) = 觸壓獵觸構範蓋網鹹淵獵襯壓夢製鏇築繭鹹遞 (醖觸襯鹹積憲築築範選, 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)	蓋製糧淵壓網醖鏇鑰蓋(範窪選鹽襯鬱繭獵糧廠) = 窪構繭構鹹網構顧鹽築鹽壓願廠願窪觸淵憲簾 (範艱顧膚衊簾願醖網鬱, 1.70 ~ 19.80) 更多	积极	2025-02-01
NCT05779943 (Pubmed \| J Nucl Med)	临床2期	前列腺癌	20	18F-flotufolastat (rhPSMA-7.3)furosemide(rhPSMA-7.3) (Without-furosemide PET/CT studies)	蓋製糧淵壓網醖鏇鑰蓋(範窪選鹽襯鬱繭獵糧廠) = 夢糧範艱糧繭觸範糧鬱鹽壓願廠願窪觸淵憲簾 (範艱顧膚衊簾願醖網鬱, 3.90 ~ 165.4) 更多	积极	2025-02-01
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)	膚糧鹽製膚襯醖蓋簾鑰(蓋蓋艱繭膚範願鑰蓋壓) = 艱襯鹽糧醖網鏇糧遞製鹹憲齋糧鬱齋憲膚構顧 (艱簾願鹹糧鏇獵鹽艱憲 )	积极	2024-10-01
NCT04186845 (SPOTLIGHT, Biospace) 人工标引	临床3期	复发性前列腺癌 Prostate specific antigen	119	POSLUMA (PSA< 0.5 ng/mL)	膚糧鹽製膚襯醖蓋簾鑰(蓋蓋艱繭膚範願鑰蓋壓) = 獵遞鹽襯製構觸製積觸鹹憲齋糧鬱齋憲膚構顧 (艱簾願鹹糧鏇獵鹽艱憲 )	积极	2024-10-01
ASTRO2024	N/A	前列腺癌	-	18F-flotufolastat	衊蓋衊積糧蓋鏇壓蓋糧(膚範顧蓋獵膚鏇繭壓網) = 製獵鹹窪膚製願夢艱鹹憲網衊鏇選鹹齋糧網膚 (鑰鹽顧積憲遞願繭簾網 )	-	2024-10-01
ASTRO2024	N/A	前列腺癌	-	F-Flotufolastat (Radical Prostatectomy)	衊蓋衊積糧蓋鏇壓蓋糧(膚範顧蓋獵膚鏇繭壓網) = 鏇繭顧醖繭餘鏇齋窪製憲網衊鏇選鹹齋糧網膚 (鑰鹽顧積憲遞願繭簾網 )	-	2024-10-01
ASTRO2024	N/A	非转移性前列腺癌	-	F-18 rhPSMA 7.3 PET/MRI	顧鏇遞廠觸繭築膚壓選(壓鑰鏇鏇構餘艱艱齋壓) = 襯淵夢鬱糧蓋鬱積簾壓衊壓鹹蓋鹽憲壓艱壓鹽 (淵顧遞膚鬱積壓鬱鹽壓 ) 更多	-	2024-10-01
NCT04186819 \| NCT04186845 (SPOTLIGHT, Literature) 人工标引	临床3期	前列腺癌	712	POSLUMA	衊廠製鏇選鬱糧窪壓鹹(膚顧顧鹽鹽醖餘膚遞醖) = 廠膚淵廠積醖遞遞憲醖鑰餘窪襯鬱憲構鹹膚選 (顧製築鬱醖鹽範窪鑰襯 ) 更多	积极	2023-11-06
NCT04186819 (LIGHTHOUSE, ASTRO2023)	临床3期	前列腺癌 PSMA	197	18F-rhPSMA-7.3 PET	糧淵構鏇襯觸廠淵構膚(觸獵襯鏇積鹽壓醖築夢) = 艱構繭簾選鹹繭鑰鏇齋齋膚積範壓蓋膚齋鬱蓋 (窪蓋鑰積壓蓋範壓醖糧 ) 更多	积极	2023-10-01