This phase II trial studies how well prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans (in combination with bone scans) work in selecting patients for Ra-223 radiation therapy that have castration-resistant prostate cancer that has spread from where it first started (primary site) to the bones (bone metastasis). Ra-223 is a type of therapy that emits radiation. Radiation gives off energy which can kill tumor cells and other cells that may support the tumor cells. Ra-223 is given by infusion into the veins, where it is absorbed by the bones. PSMA PET is a type of scan used to detect prostate cancer tumors. PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells. The PSMA tracer shows the areas on the PET scan where tumor cells are active. A PET scan uses a special camera to detect the energy given off from radioactive tracers (such as PSMA) to make detailed pictures of areas where the tracer accumulates in the body. The PET scan is often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan, which helps to map the locations where PSMA has accumulated. PSMA PET scans may be able to select patients that will benefit the most from Ra-223 treatment.

开始日期2024-08-30

申办/合作机构

The University of California, San Francisco

[+1]

NL-OMON56209 / SuspendedN/A

A FEASIBILITY STUDY OF 177LU-PSMA RADIOLIGAND THERAPY ALTERNATED WITH RADIUM-223 IN PATIENTS WITH BONE-METASTATIC, OLIGO-METASTATIC HORMONE-SENSITIVE PROSTATE CANCER AFTER CURATIVE THERAPY. THE DUET STUDY - DUET trial

开始日期2023-12-01

申办/合作机构

Amsterdam University Medical Center

NCT05771896 / Withdrawn临床3期

A Phase III Randomized Study Comparing the Combination of Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)

The goal of this clinical trial is to compare the combination of Darolutamide with Radium-223 or placebo and the effects on radiological progression-free survival for patients with Metastatic Castration-Sensitive Prostrate Cancer (mCSPC)
The main questions it aims to answer are:
Radiological progression-free survival (rPFS) in mCSPC
Overall Survival (OS)
Symptomatic skeletal event-free survival (SSE-FS)
Initiation of subsequent antineoplastic therapy
Safety
Participants will have visits at baseline, treatment is once a month for up to 6 months, and long term follow up will continue until the participant dies, withdraws consent, and/or study is terminated.

开始日期2023-09-01

申办/合作机构

GenesisCare USA Holdings, Inc.

[+1]

100 项与二氯化镭[223Ra] 相关的临床结果

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100 项与二氯化镭[223Ra] 相关的转化医学

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100 项与二氯化镭[223Ra] 相关的专利（医药）

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1,007

项与二氯化镭[223Ra] 相关的文献（医药）

2025-01-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Targets for improving prostate tumor response to radiotherapy

Review

作者: Li, Fengguang ; Jiang, Maozhu ; Zhang, Haiying ; Maozhu jiang ; Yu, Yizhi

Prostate cancer is a prevalent malignancy that is frequently managed with radiotherapy. However, resistance to radiotherapy remains a significant challenge in controlling this disease. Early radiotherapy is employed for locally confined prostate cancer (PCa), while recurrent disease post-surgery and metastatic castration-resistant prostate cancer (mCRPC) are treated with late-stage radiotherapy, including radium-223. Combination therapies to integrate radiotherapy and chemotherapy have demonstrated enhanced treatment efficacy. Nonetheless, both modalities can induce severe local and systemic toxicities. Consequently, selectively sensitizing prostate tumors to radiotherapy could improve therapeutic outcomes while minimizing systemic side effects. The mechanisms underlying radioresistance in prostate cancer are multifaceted, including DNA damage repair (DDR) pathways, hypoxia, angiogenesis, androgen receptor (AR) signaling, and immune evasion. The advent of 177Lu-PSMA-617, which was approved in 2022, has shown promise in targeting prostate-specific membrane antigen (PSMA) in advanced prostate cancer. Experimental and clinical studies have yielded promising results in suppressing prostate tumors by targeting these pathways. This paper reviews potential targets for sensitizing prostate tumors to radiotherapy. We discuss cellular and molecular mechanisms contributing to therapy resistance and examine findings from experimental and clinical trials on promising targets and drugs that can be used in combination with radiotherapy.

2024-12-01·American journal of ophthalmology case reports

Bilateral neovascular glaucoma associated with Radium-223 infusions for prostate cancer

Article

作者: Rho, Jonathan Y. ; Rho, Jonathan Y ; Viscardi, Chelsea M ; Blake, Charles R. ; Viscardi, Chelsea M. ; Blake, Charles R

Purpose:

To report two cases of neovascular glaucoma associated with Radium-223 infusion.

Observations:

Presented are two patients with metastatic prostate cancer who developed uncontrolled intraocular pressure secondary to neovascular glaucoma requiring surgical intervention. Both patients had received six cycles of Radium-223, a calcium mimetic that causes DNA double strand breaks and tumor cell death in bony metastases as part of their treatment regimen for metastatic prostate cancer. One patient had been a prior glaucoma suspect while the other had no significant ocular history.

Conclusions and importance:

Radium-223 may increase vascular permeability contributing to uveitis and promote angiostimulatory growth factors that can lead to neovascularization. We postulate this is through possible disruption in VEGF signaling pathways as well as Ra-223's calcium mimetic properties that could affect the trabecular meshwork. Neovascular glaucoma is uncommonly reported with Ra-223. There is one other case report that experienced uveitis and hyphema within weeks of the Ra-223 infusion. This case report has a similar proposed biologic mechanism. A literature review using the key words "radium-223, neovascularization, secondary angle closure glaucoma, neovascular glaucoma" did not yield any prior reports of neovascular glaucoma associated with Ra-223. The goal of this case series is to argue there is biological plausibility and to contribute to current literature of possible ocular complications of Ra-223 infusion.

2024-12-01·IEEE TRANSACTIONS ON MEDICAL IMAGING

Joint Regional Uptake Quantification of Thorium-227 and Radium-223 Using a Multiple-Energy-Window Projection-Domain Quantitative SPECT Method

Article

作者: Benabdallah, Nadia ; Thorek, Daniel L. J. ; Wahl, Richard L. ; Jha, Abhinav K. ; Laforest, Richard ; Li, Zekun

Thorium-227 (²²⁷Th)-based α-particle radiopharmaceutical therapies (α-RPTs) are currently being investigated in several clinical and pre-clinical studies. After administration, ²²⁷Th decays to ²²³Ra, another α-particle-emitting isotope, which redistributes within the patient. Reliable dose quantification of both ²²⁷Th and ²²³Ra is clinically important, and SPECT may perform this quantification as these isotopes also emit X- and γ-ray photons. However, reliable quantification is challenging for several reasons: the orders-of-magnitude lower activity compared to conventional SPECT, resulting in a very low number of detected counts, the presence of multiple photopeaks, substantial overlap in the emission spectra of these isotopes, and the image-degrading effects in SPECT. To address these issues, we propose a multiple-energy-window projection-domain quantification (MEW-PDQ) method that jointly estimates the regional activity uptake of both ²²⁷Th and ²²³Ra directly using the SPECT projection data from multiple energy windows. We evaluated the method with realistic simulation studies conducted with anthropomorphic digital phantoms, including a virtual imaging trial, in the context of imaging patients with bone metastases of prostate cancer who were treated with ²²⁷Th-based α-RPTs. The proposed method yielded reliable (accurate and precise) regional uptake estimates of both isotopes and outperformed state-of-the-art methods across different lesion sizes and contrasts, as well as in the virtual imaging trial. This reliable performance was also observed with moderate levels of intra-regional heterogeneous uptake as well as when there were moderate inaccuracies in the definitions of the support of various regions. Additionally, we demonstrated the effectiveness of using multiple energy windows and the variance of the estimated uptake using the proposed method approached the Cramér-Rao-lower-bound-defined theoretical limit. These results provide strong evidence in support of this method for reliable uptake quantification in ²²⁷Th-based α-RPTs.

112

项与二氯化镭[223Ra] 相关的新闻（医药）

2024-12-28

·ioncology

EAU官方期刊 | 转移性前列腺癌的系统治疗策略

点击蓝字，关注我们编者按：雄激素剥夺疗法（ADT）是转移性激素敏感性前列腺癌（mHSPC）的基石性方案，但大多数患者会不可避免地发展为转移性去势抵抗性前列腺癌（mCRPC）。而随着新型雄激素受体通路抑制剂（ARPI）、化疗和放射性配体疗法的出现以及精准医疗的应用，治疗格局发生了重大变化。2024年的一篇文章总结了转移性前列腺癌的系统治疗方案，并讨论了治疗顺序的选择问题。本刊特别整理，以飨读者。 01 ARPI ARPI包括类固醇生成抑制剂阿比特龙和第三代抗雄激素药物阿帕他胺、达罗他胺和恩扎卢胺等。ARPI最初用于多西他赛治疗之前或之后的mCRPC患者，结果显示其能够显著延缓进展、延长总生存期（OS）并改善患者的生活质量[1,2]。阿帕他胺、恩扎卢胺和达罗他胺还可显著延长高危非转移性CRPC（前列腺特异性抗原倍增时间<10个月）患者的无转移生存期和OS。过去十年的证据，强调了ARPI联合ADT对mHSPC患者的影响[3]。结果证明，无论疾病体积或风险级别如何，强化ADT治疗均可显著延缓放射学进展和去势抵抗时间，并延长OS。为了克服mHSPC诊断时的肿瘤异质性，已经探索了多西他赛+ADT+新型内分泌治疗药物的三联疗法。结果表明，ADT仅联合多西他赛的方案不应再被视为标准治疗方法。尽管有证据证实应选择ADT联合ARPI方案，但并未真正阐明哪些患者可以从联合多西他赛的方案中受益。对于能够接受化疗且患同时性（新发）高瘤负荷患者，首选三联疗法可能更为合适。对于异时性低瘤负荷患者以及不适合或拒绝化疗的患者，可以提供ADT联合ARPI的双联疗法。 02 化疗基于紫杉烷的化疗可显着改善mCRPC的预后，因此仍然是mCRPC的主要治疗方案。多西他赛历来被监管机构推荐为mCRPC的一线治疗。卡巴他赛是为了克服对多西他赛的耐药性而开发，虽然卡巴他赛在一线mCRPC中并不优于多西他赛，但前瞻性证据表明，卡巴他赛可增加多西他赛失败或快速进展患者的无进展生存期和OS，并且对多西他赛和ARPI进展的患者同样有效[4]。 03 放射性配体疗法镭-223是一种骨靶向的放射性配体疗法，无论既往是否接受过治疗，均可改善mCRPC和有症状骨转移患者的OS。在考虑使用Ra-223治疗时，对于存在骨骼受累的mCRPC患者，必须使用地舒单抗等具有骨骼保护的药物。此外，临床医生应认识到前列腺特异性抗原可能不是Ra-223疗效的最准确指标；相反，碱性磷酸酶水平下降似乎是治疗缓解的更可靠指标[5]。前列腺特异性膜抗原（PSMA）放射性配体177Lu-PSMA-617可将177Lu直接输送到表面表达PSMA的前列腺癌细胞。3期VISION试验表明，与医生选择的治疗相比，对于PSMA-PET结果阳性且经过多西他赛和ARPI治疗的mCRPC患者，Lu-PSMA治疗可延迟放射学PFS和OS[6]。 04 PARP抑制剂奥拉帕利目前已经被批准单药治疗ARPI和化疗失败后的携带胚系或体细胞BRCA1/2突变mCRPC患者[7]。3期TRITON试验的最新结果表明，对于BRCA1/2突变的mCRPC患者，在ARPI治疗过程中出现进展，rucaparib可显著延长放射学PFS，优于多西他赛，未来有可能将rucaparib的适应症扩展到未接受化疗的BRCA1/2突变的mCRPC患者。此外，多项试验评估了PARP抑制剂+ARPI对于ADT治疗过程中出现进展的mCRPC患者的效果，无论其DDR基因状态如何。有趣的是，在包括DDR突变型和DDR野生型患者的意向治疗人群中，与阿比特龙或恩扎卢胺相比，阿比特龙/奥拉帕利和恩扎卢胺/他拉唑帕利的组合改善了放射学PFS。然而，这种获益是由BRCA1/2突变推动。重要的是，目前没有关于ARPI联合PARP抑制剂对一线ARPI后进展患者获益的数据。 05 全身治疗的最佳顺序选择逐渐地，越来越多的患者在接受ADT和ARPI治疗后进入去势抵抗期。对于适合化疗的患者，如果既往未在mHSPC阶段给予多西他赛，则多西他赛仍然是mCRPC的一线治疗。疾病进展较慢、无肝转移、病变平均标准化摄取值高、PET上无氟脱氧葡萄糖摄取不一致病变是预后特征，可能有利于BRCA1/2阴性患者的放射性配体治疗，而对于BRCA1/2突变患者，PARP抑制剂可能优先于其他可用药物。任何既往未给予的治疗都应在进展后提供，以提高患者生存率。 06 结论晚期转移性前列腺癌是一种异质性疾病，目前ADT联合ARPI疗法是主要治疗方法。在ARPI治疗后，可依次使用所有可用的后续疗法。然而，患者选择成为关键。目前尚未满足的需求是确定临床或分子预测因素，以协助临床医生选择合适的全身治疗顺序。参考文献：（滑动查看） 1. J.S. de Bono, C.J. Logothetis, A. Molina, et al. Abiraterone and increased survival in metastatic prostate cancer N Engl J Med, 364 (2011), pp. 1995-2005, 10.1056/NEJMoa1014618 2. H.I. Scher, K. Fizazi, F. Saad, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy N Engl J Med, 367 (2012), pp. 1187-1197, 10.1056/NEJMoa1207506 3. A.A. Ahmid, N. Sayegh, B. Tombal, et al. Metastatic hormone sensitive prostate cancer: toward an era of adaptive and personalized treatment Am Soc Clin Oncol Educ Book, 43 (2023), Article e390166, 10.1200/EDBK_390166 4. R. de Wit, J. de Bono, C.N. Sternberg, et al. Cabazitaxel versus abiraterone or enzalutamide in metastatic prostate cancer N Engl J Med, 381 (2019), pp. 2506-2518 5. C. Parker, S. Nilsson, D. Heinrich, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med., 369 (2013), pp. 213-223, 10.1056/NEJMoa1213755 6. Sartor, J. de Bono, K.N. Chi, et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med, 385 (2021), pp. 1091-1103 7. M. Hussain, J. Mateo, K. Fizazi, et al. Survival with olaparib in metastatic castration-resistant prostate cancer. N Engl J Med, 383 (2020), pp. 2345-2357 （来源：《肿瘤瞭望-泌尿时讯》编辑部）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。

放射疗法临床结果临床3期

2024-12-17

·ioncology

前腺解泌丨更多组合更前拓展——谢建军教授回顾ESMO前列腺癌系统治疗研究进展

编者按：2024年欧洲肿瘤内科学会（ESMO）年会已经落下帷幕，在前列腺癌系统治疗领域，有许多可圈可点的研究给人留下深刻印象。在雄激素剥夺治疗（ADT）基础上，新型内分泌治疗（NHT）联合核素治疗、PAPR抑制剂等不同联合治疗已经应用于转移性去势抵抗性前列腺癌（mCRPC）和转移性激素敏感性前列腺癌（mHSPC）领域，而NHT单药或联合ADT在生化复发阶段的EMBARK研究也有更多亚组分析。在本期由中国人体健康促进会主办的医生学习栏目中，《肿瘤瞭望》特邀苏州市立医院谢建军教授回顾2024年ESMO大会的前列腺癌系统治疗研究进展。 01 《肿瘤瞭望》：在mCRPC领域，NHT+ADT已经成为治疗标准，近年来的研究将此作为基础治疗方案，进行了更多联合方案的探索。能否介绍一下本次ESMO大会的重要研究进展？谢建军教授苏州市立医院基于PREVAIL、Asian PREVAIL等3期临床试验，恩扎卢胺及多款新型内分泌治疗（NHT）联合ADT已经获批用于mCRPC一线治疗，并且成为国内指南推荐的标准方案。近年来，越来越多的研究在此基础上，进行了更多的联合治疗方案探索，包括NHT+ADT+靶向治疗、免疫治疗、核素治疗等。本次ESMO大会的首场全体大会上PEACE-3研究作为“头号”重磅摘要（LBA1）精彩亮相，得到非常高的关注度。这项3期研究探讨了在恩扎卢胺的基础上进一步联合Ra223用于治疗无症状或轻度症状的骨转移性mCRPC患者，结果显示有显著的治疗获益，rPFS从单药组的16.4个月延长至联合组的19.4个月（HR 0.69 ；95%CI：0.54-0.87，P=0.0009）；OS从35.0个月延长至42.3个月（HR 0.69；95%CI：0.52-0.90，P=0.0031），且安全性和耐受性良好，≥3级TRAEs发生率分别为28%和19%[1]。 △PEACE-3研究的rPFS和OS结果另一个值得关注的是，这次大会还报道了TALAPRO-2中国人群的数据，此前该研究已经报道在总人群（未经HRR选择NR vs. 21.9个月；HR 0.69，P＜0.001）、HRD突变患者（HR 0.46，P＜0.001）、HRD未知/阴性患者（HR 0.70，P=0.004）中恩扎卢胺+他拉唑帕利治疗的rPFS获益[2]。这次报道的中国患者数据显示了一致甚至更好的获益，总人群（33.3 vs 10.9个月；HR 0.30；P＜0.0001）、HRD突变患者（15.7 vs 4.0个月，HR 0.16；P=0.0044）、HRD未知/阴性患者（35.9 vs 13.8个月，HR 0.36；P=0.0018）的rPFS风险降低幅度均大于全球患者[3]。近期（2024年10月11日），企业方宣布该研究达到OS结果，总人群和HRD患者均有显著意义和临床意义的OS获益[4]，而在此次ESMO报道的中国患者中也显示了积极OS结果，总人群的死亡风险显著降低50%（HR 0.50；P=0.013）；这是全球首个也是唯一一个PARP抑制剂联合NHT一线治疗可显著改善mCRPC患者OS的药物组合，而PROpel研究目前尚未获OS阳性结果（HR 0.81）。 △TALAPRO-2研究中国患者的rPFS和OS结果 EACE-3及TALAPRO-2研究的成功，再次肯定了NHT作为mCRPC的治疗基础，我们可以进行更多联合治疗策略的探索，而且不同方案均有不同的使用人群，形成更加丰富的“分类治疗”策略：（1）首先，存在无症状或轻微症状骨转移的患者，可考虑在恩扎卢胺基础上联合Ra233，而恩扎卢胺联合新型靶向核素治疗177Lu-PSMA-617的2期ENZA-p研究已经取得积极结果（PSA-PFS：13.0 vs 7.8个月，HR 0.43，P<0.0001），期待3期研究带来更多好消息，该联合方案则可以用于PSMA阳性的患者；（2）再者，携带同源重组修复缺陷（HRD）基因的患者则可以联合PARP抑制剂，当然，TALAPRO-2研究显示总人群（即不考虑HRR状态）可从恩扎卢胺加PARP抑制剂治疗中带来生存获益，该方案的选择可以不用考虑HRR状态，而PROpel研究方案目前主要适用于HRD患者；（3）未来也将探讨联合免疫治疗、抗体偶联药物（ADC）等其他新型治疗的获益人群。 02 《肿瘤瞭望》：在mHSPC领域，NHT+ADT也成为标准治疗方案，而且同样也有更多三药或四药组合方案的探索。那么这次ESMO大会上有哪些重要研究进展？谢建军教授苏州市立医院在mHSPC领域，目前已经有多个NHT+ADT方案在国内外获批，其中恩扎卢胺积累多项3期临床试验提供的循证医学证据，包括ENZAMET、ARCHES、China ARCHES等国内外研究，均证实了恩扎卢胺+ADT在高瘤负荷或低瘤负荷mHPSC患者中一致的生存获益，尤其在China ARCHES中，中国患者显示了更好的获益趋势，rPFS事件风险显著降低67%（HR 0.330），而全球患者为37%（HR 0.63）。基于此，中国NMPA批准了恩扎卢胺mHSPC的适应症。至此，恩扎卢胺在国内的适应症已经覆盖nmCRPC、mHSPC和mCRPC。 △China ARCHES研究主要结果近年来，学术界进一步探索更多的联合治疗策略，例如ARASENS研究已经证实了“三联”策略（NHT＋ADT＋化疗），PEACE-1研究的“三联或四联”策略（NHT＋ADT＋放化疗），但这些更加强化的治疗方案可增加一定的毒副作用，治疗获益主要在高肿瘤负荷或高危人群中。本次ESMO大会带来了更多的恩扎卢胺联合治疗策略探索。随着TALAPRO-2研究的成功，恩扎卢胺+ADT+PARPi的“三联方案”可进一步向前拓展。ZZFIRST（NCT04332744）是一项西班牙研究者发起的2期多中心研究[5]，入组了54例高肿瘤负荷的mHNPC（未经内分泌治疗的转移性前列腺癌）患者，先接受2个周期的恩扎卢胺+ADT治疗，随后分别接受恩扎卢胺+ADT+他拉唑帕利或安慰剂治疗。研究结果显示治疗13周期第1天（C13D1），相较于“二联”方案，“三联”方案的PSA完全缓解率（PSA-CR）有显著提升8.3%（73.0% vs 64.7%，P＜0.001），rPFS事件风险降低50%（NR vs 31.1个月，HR 0.50）；安全性和耐受性良好，常见≥3级AE为疲劳（13.5%）和贫血（37.8%）。 △ZZFIRST研究PFS、PSA-PFS和常见不良反应 03 《肿瘤瞭望》：在局限性前列腺癌领域，EMBARK研究是首个NHT用于此类人群获得阳性结果的3期临床试验，能否介绍一下这个领域的最新ESMO研究进展？谢建军教授苏州市立医院前列腺癌生化复发（BCR）是指根治性治疗后发生PSA升高异常，而没有影像学转移证据。此类患者的局部或远处转移风险也较高，但目前尚未有标准的治疗方式来降低其复发风险，临床较为常用的方法是挽救性放疗或者放疗联合ADT，但放疗的放射性毒副作用较大。 EMBARK研究是全球首个将新型内分泌治疗用于生化复发高危患者，且取得阳性结果的3期临床试验，该研究入组根治术后PSA≥1ng/mL或首次EBRT放疗后PSA最低值＞2ng/mL，PSA倍增时间（PSADT）≤9个月的患者，随机分为恩扎卢胺＋ADT组、恩扎卢胺组、ADT组。去年NEJM报道该研究达到了主要终点：恩扎卢胺＋ADT组相较于ADT组的5年MFS率提高了15.9%（87.3% vs 71.4%），转移疾病风险显著降低58%（HR 0.42，P＜0.0001）。在关于单药组的次要终点方面，也显示恩扎卢胺单药组相较于ADT组的转移疾病风险降低37%（MFS：NR vs NR；HR 0.63，P=0.049）[6]。 EMBARK研究对BCR治疗模式的探索很有借鉴意义，既往报道对于治疗36周达到PSA小于0.2ng/ml的患者，即可以停止治疗，这种模式不仅没有减少疗效获益，而且可以改善患者生活质量。此次ESMO报道了不同年龄人群的事后分析[7]显示，该治疗方案对老年人也非常“友好”。首先对于≥70岁的患者（HR 0.495），与＜70岁的患者（HR 0.368），恩扎卢胺联合治疗均可相较于ADT改善患者MFS。当然，≥70岁老年患者的严重不良事件要高于＜70岁患者（45.0% vs 25.3%）。对于不耐受联合治疗的老年患者，可以考虑接受恩扎卢胺单药治疗，而这两个年龄人群接受单药治疗（≥70岁：HR 0.611；＜70岁：HR 0.671）同样均有MFS改善。 △EMBARK研究按照年龄分层的MFS和不良反应 EMBARK研究开启了NHT治疗高危BCR患者辅助治疗的里程碑，使得NHT进一步拓展至早期治疗阶段，我们期待未来NHT能够进一步在早期新辅助治疗和辅助治疗领域进行更多研究探索使更多患者获得治愈机会 04 《肿瘤瞭望》：除了上述研究以外，您认为本次ESMO大会还有哪些研究对未来前列腺癌的探索，可以带来一些思考和启发？谢建军教授苏州市立医院从上述研究可见，恩扎卢胺等NHT已经观察mCRPC、nmCRPC、mHSPC、BCR阶段，NHT+ADT已经成为新的基础治疗方案（以往主要以ADT作为基础治疗），而且在此基础上进行了许多联合治疗的探索，包括联合靶向、免疫、核素治疗等多种组合。本次ESMO大会有很多重磅研究的公布，各类新型治疗大放异彩，我本人比较关注的是免疫治疗，因为去年ESMO报道的两项3期研究（针对mHSPC的KEYNOTE-991研究和针对mCRPC的KEYNOTE-641研究），NHT+免疫检查点抑制剂（ICI）均未取得阳性结果。前列腺癌作为免疫“冷肿瘤”，ICI治疗可能需要进一步探讨具有免疫协同增敏的治疗策略，并筛选优势获益人群。这次ESMO大会报道的一项2期单臂研究[8]，探讨了在双免治疗（纳武利尤单抗+伊匹木单抗）治疗mCRPC患者，并分析不同生物标志人群的疗效研究结果显示，总人群的ORR达38%，其中MMRd（体细胞错配修复蛋白缺陷）人群的ORR高达75%，PFS和OS的获益趋势也是如此，总人群的中位PFS和MMRd人群的中位PFS分别为4.0个月和32.7个月，MMRd人群或可作为双免治疗的优势人群。 △2期研究双免治疗mCRPC患者的疗效汇总此外，著名的多队列平台研究STAMPEDE在这次ESMO大会报道了二甲双胍联合ADT治疗mHSPC能够改善高瘤负荷患者的OS（HR 0.79，P=0.006）[9]，二甲双胍的这种治疗获益可能来自对代谢性疾病的有利作用，包括减少体重增加、降低空腹血糖和糖化血红蛋白、血脂等，这也从侧面反映，对于以老年人为主要发病群体的前列腺癌，应该重视此类心脑血管、代谢性疾病的预防和控制。因为随着联合治疗策略的使用增加，患者可能存在更加复杂的并发症，需要通过综合管理的手段使患者获益最大化，包括延长生存和改善生活质量。参考文献上下滑动查看更多内容 [1] Silke Gillessen, et al.A randomized multicenter open label phase III trial comparing enzalutamide vs a combination of Radium-223 (Ra223) and enzalutamide in asymptomatic or mildly symptomatic patients with bone metastatic castration-resistant prostate cancer (mCRPC): First results of EORTC-GUCG 1333/PEACE-3.ESMO 2024;LBA1 [2] Neeraj Agarwal, et al.TALAPRO-2: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).ASCO-GU 2023;LBA17 [3] Hao Zeng,et al.Phase III study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): TALAPRO-2 (TP-2) China cohort.ESMO2024;1633P [4] Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs Overall Survival in Phase 3 TALAPRO-2 Trial. Thursday, October 10, 2024 - 06:51am,https://www.pfizer.com/news/press-release/press-release-detail/pfizers-talzennar-combination-xtandir-prolongs-overall [5] Joaquin Mateo,et al.First results from ZZFIRST: A randomized phase II trial of enzalutamide (EZ) with or without talazoparib (TALA) in metastatic hormone-naïve prostate cancer (mHNPC).ESMO2024;1601P [6] Freedland SJ, de Almeida Luz M, De Giorgi U, et al. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2023;389(16):1453-1465. doi:10.1056/NEJMoa2303974 [7] Neal Shore, et al.Enzalutamide (enza) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post hoc analysis by age.ESMO2024;1638P [8] Niven Mehra, et al.Nivolumab 3mg/kg and ipilimumab 1mg/kg (nivo3/ipi1) in molecularly selected patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).ESMO 2024;LBA72 [9] Adding metformin to androgen deprivation therapy (ADT) for patients (pts) with metastatic hormone sensitive prostate cancer (mHSPC): Overall survival (OS) results from the multi-arm, multi-stage randomised platform trial STAMPEDE.ESMO 2024;LBA70 谢建军教授苏州市立医院医学博士，主任医师，硕士研究生导师日本昭和大学/日本国立医疗中心高级访问学者苏州市立医院泌尿外科行政主任中国老年保健协会生殖健康专业委员会委员中国民族卫生协会卫生健康技术推广专家委员江苏省医学会医用机器人分会委员江苏省医学会泌尿外科分会委员江苏省研究型医院学会男科分会常委江苏省社会办医疗机构协会泌尿外科专业委员会委员苏州中西医结合学会泌尿外科分会副主任委员主译：《儿童及成人肾上腺肿瘤诊治》。获江苏省医学会泌尿外科分会中青年手术视频大赛一等奖。擅长泌尿系肿瘤及肾上腺疾病手术治疗。特别鸣谢：北京安斯泰来医药有限公司（来源：《肿瘤瞭望》编辑部）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。

临床结果临床3期临床终止

2024-12-03

·GlobeNewswire-Health Care

Nusano Names Medical Radioisotopes Advisory Board

VALENCIA, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Nusano, a physics company transforming the production of radioisotopes, today announced the creation of a Medical Radioisotopes Advisory Board. This panel of internationally recognized leaders in nuclear medicine will provide strategic guidance to Nusano, ensuring its product development aligns with emerging trends and with the needs of cancer patients. The board will also guide the development of isotopes for next-generation theranostic compounds. “As a radioisotope producer, Nusano plays a critical role in the supply chains of drug developers, healthcare providers and researchers,” said Chris Lowe, CEO of Nusano. “Establishing a Medical Radioisotopes Advisory Board reflects our ongoing commitment to proactively enabling the next generation of oncology research. The board’s guidance will ensure Nusano is providing a stable and scalable supply of isotopes for new areas of research and patient care.” Radioisotopes are essential components in the active pharmaceutical ingredients (API) used in new and emerging cancer therapies including molecular radiation. Existing supply chains for these treatment-enabling resources are often strained, posing a risk to patient care, clinical trials, and ongoing drug development. Nusano is working to stabilize supply chains and enable innovation by bringing new sources of radioisotopes to multiple markets. Opening in 2025 in West Valley City, Utah, the Nusano production platform will be capable of generating more than 40 radioisotopes applicable to medical and industrial uses. It is anchored by a proprietary ion source technology which accelerates heavy particles (alphas and deuterons) to generate high volume, high quality (CGMP-grade) radioisotopes with unparalleled efficiency using eco-friendly methods. The result is one of the first significant advancements in radioisotope production in decades. The five members of the Nusano advisory board are (listed alphabetically by last name): Munir GhesaniMunir Ghesani, MD, FACNM, FACR, FSNMMI, is the Medical Director of United Theranostics in Princeton and the Chief Medical Officer of United Theranostics. He previously served as the Systems Chief of Nuclear Medicine and Molecular Imaging at Mount Sinai Health System in New York. Dr. Ghesani has been actively involved in clinical practice, research, clinical trials, and education for over 25 years, primarily focusing on nuclear medicine, molecular imaging, and targeted radiopharmaceutical therapies. Dr. Ghesani has authored more than 200 publications in peer-reviewed journals and is the Editor-in-Chief of a three-part book on nuclear medicine and molecular imaging. He has delivered over 150 presentations at regional, national, and international conferences. Dr. Ghesani has held leadership roles in various societies and colleges, including Immediate Past President of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), Past-President of the Education and Research Foundation of Nuclear Medicine and Molecular Imaging, Past Chairman of the American Board of Nuclear Medicine, Past Chairman of the Government Relations Committee, and the FDA Task Force of the SNMMI, as well as Past Chairman of the Nuclear Medicine and PET Accreditation Committee of the American College of Radiology. In January 2020, he was awarded the ACNM Personal Best Mentor of the Year. He has also been recognized as a Fellow of the American College of Nuclear Medicine (2006), the American College of Radiology (2018), and the Society of Nuclear Medicine and Molecular Imaging (2023). Suzanne LapiSuzanne E. Lapi, Ph.D. is the Emmet O’Neal II Professor, O’Neal Comprehensive Cancer Center and Professor of Radiology and Chemistry and Cyclotron Facility Director at the University of Alabama at Birmingham. She is also the Vice Chair of Research in the Department of Radiology. Her research interests are in the development and translation of new PET radionuclides and molecular imaging agents. She has over 150 publications and is principal investigator on active research grants from the National Institutes of Health (NIH) and United States Department of Energy (DOE), as well as industry partners. She oversees production of PET radionuclides and imaging radiopharmaceuticals for preclinical research and clinical trials. Her group holds more than 15 approved INDs and supplies Cu-64, Zr-89, Mn-52 and other isotopes to groups across the USA and internationally. She is a Fellow of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and a strong advocate of radiopharmaceutical sciences and the training of future nuclear and radiochemists at the graduate, postdoctoral and faculty levels. Luke NordquistThe CEO of the XCancer® Organization, Dr. Luke Nordquist is a practicing Medical Oncologist with an expertise in prostate cancer. Nordquist’s Community Cancer Center in Omaha, Neb. is internationally known, gaining recognition for its participation in early and late phase radiopharmaceutical trials of Ra-223, Lu-177, Ac-225, Th-227, Pb-212, Zr89, In111, Cu-64, and Cu-67. Nordquist and his XCancer team have conducted over 40 imaging & therapeutic Theranostic trials to date including 22 Firsts-in-World trials. His research program is recognized for rapid start-ups, high accruals, and exceptional data timeliness and quality. Dr. Nordquist is also the Founder of TheranosticTrials.Org, a digital platform increasing education and access of global Theranostic trials. Through his XCancer® Research Network, Nordquist is working to provide access to cutting edge clinical trials closer to home. In so doing, he and his collaborators are to increase community cancer center participation and drive improved access for cancer patients regardless of geography. Philip KooDr. Koo is the Chief of Diagnostic Imaging at the Banner MD Anderson Cancer Center in Phoenix, AZ. Prior to this, he was Chief of Nuclear Medicine and Associate Professor of Radiology at the University of Colorado School of Medicine. Dr. Koo completed his transitional internship at the University of Pennsylvania Medical Center-Presbyterian, radiology residency at Pennsylvania Hospital of the University of Pennsylvania Health System, and fellowship at the Harvard Medical School Joint Program in Nuclear Medicine. He is a diplomate of both the American Board of Radiology (ABR) and American Board of Nuclear Medicine. Dr. Koo’s academic interests have focused on nuclear medicine in prostate cancer and response to novel therapies using PET, with over 80 peer reviewed publications and abstracts. He has lectured nationally and internationally on topics related to imaging and radiopharmaceutical based therapies in prostate cancer. Dr. Koo is the Founding Chair of the SNMMI Therapeutics Conference and received the SNMMI Presidential Distinguished Service Award in 2022. Neal ShoreNeal Shore, MD, FACS, graduated from Duke University and Duke University Medical School. He completed his general surgery/urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Kettering Cancer Center. He serves as the Medical Director for the Carolina Urologic Research Center. Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, the APCCC Scientific Steering Committee, Maple Tree Cancer Alliance, and the Duke Global Health Institute. He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy, and the co-chair of the annual AUA International Prostate Forum. He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP, Everyday Urology Oncology and World Journal of Urology. He is the Editor-in-Chief of Reviews in Urology. He is a Fellow of the American College of Surgeons and a Certified Physician Investigator. About NusanoNusano is a privately held physics company committed to bringing supply stability and innovation to the rapidly emerging and critically undersupplied medical radioisotopes market, and to serving industrial and commercial markets dependent on reliable access to high quality radioisotopes for their products and services. Driven by the company’s proprietary ion source, the Nusano production platform will generate radioisotopes in volumes and varieties exceeding other production methods. Nusano’s breakthrough technologies are poised to help supply the fight against cancer and enable innovation across multiple industries. For more, please visit nusano.com. Contacts: Media: Scott Larrivee, Nusano, 608-345-6629, scott.larrivee@nusano.comInvestor Relations: Joyce Allaire, LifeSci Advisors, LLC, 212-915-2569, jallaire@lifesciadvisors.com

高管变更

100 项与二氯化镭[223Ra] 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	二氯化镭[223Ra]	V10XX03	DB08913

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	中国	Institute For Energy Technology	2020-08-26
骨转移癌	欧盟	Bayer AG	2013-11-13
骨转移癌	冰岛	Bayer AG	2013-11-13
骨转移癌	列支敦士登	Bayer AG	2013-11-13
骨转移癌	挪威	Bayer AG	2013-11-13
去势抵抗性前列腺癌	美国	Bayer HealthCare Pharmaceuticals, Inc.	2013-05-15

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
去势敏感前列腺癌	临床3期	-	Bayer AG	2023-09-01
转移性前列腺癌	临床3期	-	Bayer AG	2023-09-01
转移性去势抵抗性前列腺癌	临床3期	中国	Bayer AG	2013-03-26
转移性去势抵抗性前列腺癌	临床3期	新加坡	Bayer AG	2013-03-26
转移性去势抵抗性前列腺癌	临床3期	韩国	Bayer AG	2013-03-26
转移性去势抵抗性前列腺癌	临床3期	中国台湾	Bayer AG	2013-03-26
寡转移性前列腺癌	临床2期	美国	Bayer AG	2019-08-09
复发性多发性骨髓瘤	临床2期	美国	Bayer AG	2016-10-01
复发性多发性骨髓瘤	临床2期	澳大利亚	Bayer AG	2016-10-01
复发性多发性骨髓瘤	临床2期	比利时	Bayer AG	2016-10-01

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临床结果

适应症

分期

评价

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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


NCT03002220 (EXCAAPE, CTgov)	临床2期	转移性去势抵抗性前列腺癌	52	radium-223	網範範鏇觸鏇鹽窪糧顧(蓋窪夢糧範鑰蓋鹽餘鹹) = 繭繭衊積廠淵淵積築鏇蓋窪鏇憲獵鹽膚壓蓋簾 (糧網繭顧製壓繭網構窪, 觸衊鏇繭襯廠選夢蓋夢 ~ 淵鑰糧鑰廠衊獵襯襯鹹) 更多	-	2024-12-11
NCT03996473 (CTgov)	临床1期	转移性非小细胞肺癌	8	Radium-223 Dichloride+Pembrolizumab (Radium-223 Dichloride + Pembrolizumab)	艱齋淵願淵願膚鑰壓選(廠壓願壓鹹鬱鏇網鑰鑰) = 觸鏇蓋積齋製淵獵願衊網顧製簾廠選鏇淵範構 (鹹衊醖顧窪憲鹹遞觸齋, 範構醖糧鏇顧顧鬱獵鹽 ~ 積鬱繭艱鹹膚簾艱遞鬱) 更多	-	2024-10-10
				Radium-223+Pembrolizumab (Radium-223 + Pembrolizumab)	製糧膚壓齋鏇鹹製鏇觸(淵蓋獵膚齋餘夢窪窪簾) = 膚餘顧艱繭網觸選鏇鬱鹹觸廠餘糧獵鹽壓糧範 (廠遞選構膚窪餘窪構範, 積鑰壓襯製餘壓壓積糧 ~ 壓襯繭繭鑰壓鹹範鬱夢) 更多
ASTRO2024	N/A	寡转移性前列腺癌	-	RAdium-223 (Stereotactic ablative radiation (SABR))	鹽艱積窪觸顧網鬱製獵(鏇窪構範遞顧鹹廠簾鏇) = 13 patients (20%) experienced grade 3 toxicity (no grade 4 or 5), of which 6 were non-treatment-related, 2 related to SABR, and 5 related to SABR/Ra223 (lymphopenia, back pain) 淵廠獵願構簾壓網膚鹽 (觸觸夢廠襯鑰顧繭鏇醖 )	-	2024-10-01
EANM2024	N/A	转移性去势抵抗性前列腺癌	57	Radium-223	廠窪憲鏇齋窪繭製艱網(顧窪憲壓淵觸鬱蓋積壓) = All hematological adverse events, including anemia (28%), decreased platelet (18%), neutropenia (2%), and lymphopenia (51%) 蓋範網醖夢壓鹽夢簾醖 (齋獵淵鏇膚範製繭膚壓 )	积极	2024-09-27
NCT02141438 (REASSURE, EANM2024)	N/A	转移性去势抵抗性前列腺癌 ALP levels	811	Radium-223 (Normal ALP/Decline)	觸願獵鑰選獵鏇鏇願艱(夢鹽窪襯衊鏇蓋網夢製) = 糧繭壓鏇餘艱觸選獵鹽鑰積築糧遞鬱鹽蓋範範 (窪遞遞襯艱獵築繭獵壓 ) 更多	积极	2024-09-27
				Radium-223 (Normal ALP/No Decline)	觸願獵鑰選獵鏇鏇願艱(夢鹽窪襯衊鏇蓋網夢製) = 襯網餘鹹遞蓋衊網獵壓鑰積築糧遞鬱鹽蓋範範 (窪遞遞襯艱獵築繭獵壓 ) 更多
NCT02141438 (REASSURE, Pubmed \| Cancer)	N/A	转移性去势抵抗性前列腺癌	182	Radium-223 + Immediate Taxane Chemotherapy	壓顧繭願襯齋廠齋觸壓(淵餘鹹網糧膚窪憲獵齋) = 糧積淵齋夢襯壓鑰願膚壓觸蓋繭遞夢鑰觸憲積 (壓鏇選艱範製網窪壓壓 )	积极	2024-06-01
				Radium-223 + Delayed Taxane Chemotherapy	壓顧繭願襯齋廠齋觸壓(淵餘鹹網糧膚窪憲獵齋) = 範遞鬱鹹蓋遞鹹網醖糧壓觸蓋繭遞夢鑰觸憲積 (壓鏇選艱範製網窪壓壓 )
NCT02925702 (PRORADIUM Study, Pubmed \| Eur Urol Oncol)	N/A	转移性去势抵抗性前列腺癌三线 bone alkaline phosphatase \| C-terminal type-I collagen propeptide \| N-terminal telopeptide ... 更多	169	Radium-223 (High baseline values in at least three bone formation biomarkers (BAP and C-terminal type-I collagen propeptide))	餘觸襯蓋齋鑰夢窪鑰艱(夢遞觸蓋夢蓋觸築範醖) = 觸築醖獵網構願範膚顧膚獵鏇鹹蓋獵膚窪範鹹 (餘鑰願簾製窪壓糧廠艱 )	积极	2024-06-01
				Radium-223 (High baseline values in at least three bone resorption biomarkers (N-terminal telopeptide and pyridinoline))	餘觸襯蓋齋鑰夢窪鑰艱(夢遞觸蓋夢蓋觸築範醖) = 願鏇網範膚製築網淵鏇膚獵鏇鹹蓋獵膚窪範鹹 (餘鑰願簾製窪壓糧廠艱 )
NCT02258464 \| NCT02258451 (Pubmed \| Breast Cancer Res Treat) 人工标引	临床2期	HR阳性乳腺癌 Hormone Receptor Positive	382	Radium-223 + Endocrine Therapy	網醖憲繭範廠餘窪窪網(壓鑰網衊鏇選築齋觸繭): HR = 0.809 (95% CI, 0.61 ~ 1.072), P-Value = 0.1389 更多	不佳	2024-04-01
				Placebo + Endocrine Therapy
NCT02903160 (PRINT, CTgov)	临床2期	去势抵抗性前列腺癌	40	Radium-223 dichloride+Enzalutamide+Cabazitaxel+Carboplatin+Prednisone+Abiraterone acetate	範淵壓選醖觸築膚簾衊(鹽壓餘鑰膚壓鹹鬱糧鏇) = 齋構鬱顧網淵膚廠齋淵築襯網糧鹽壓齋築鹽顧 (鑰膚鑰觸遞範蓋蓋蓋蓋, 選鹹壓壓鑰觸鹹衊窪鬱 ~ 膚餘遞鏇網遞積艱構膚) 更多	-	2024-02-07
NCT03304418 (RROPE, CTgov)	临床2期	转移性前列腺癌	20	Radium Ra 223 Dichloride+Radiation	夢夢衊鏇網選積獵淵鑰(願繭遞遞襯繭淵繭憲蓋) = 夢憲鬱範鏇窪醖廠夢鏇構鹹夢築顧鬱糧鹹廠衊 (顧廠鹽築淵積積觸範衊, 繭夢憲糧鏇獵積餘糧艱 ~ 醖齋遞襯製獵觸醖鹹顧) 更多	-	2024-01-30