Lutetium-177-PSMA-I&T(Lutetium-177-PSMA-I&T) - 药物靶点：PSMA_在研适应症：前列腺癌，腺样囊性癌，涎腺导管癌_专利_临床

概要

基本信息

药物类型

多肽偶联核素、治疗用放射药物

别名-

靶点

PSMA

作用机制

PSMA抑制剂(前列腺癌特异性膜抗原抑制剂)

治疗领域

肿瘤口颌疾病泌尿生殖系统疾病

在研适应症

前列腺癌腺样囊性癌涎腺导管癌+ [1]

非在研适应症-

原研机构

Radboud University Nijmegen

在研机构

Radboud University Medical Center

Radboud University NijmegenIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori SRL

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

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关联

4

项与 Lutetium-177-PSMA-I&T 相关的临床试验

IRCT20230414057906N1 / Suspended临床2期IIT

Efficacy and safetyof Lutetim-177-PSMA-617 therapy in paitents with metastatic prostate cancer after radical prostatectomyand bilateral orchitectomy

开始日期2023-05-05

申办/合作机构

Shahid Beheshti University of Medical Sciences

NCT05383079 / Recruiting临床1/2期IIT

Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer

This clinical trial will evaluate the safety of Radium-223 in combination with 177Lu-PSMA-I&T in metastatic castration-resistant prostate cancer: Phase I/II study

开始日期2022-09-13

申办/合作机构

Peter MacCallum Cancer Institute

NCT04291300 / Completed临床2期IIT

Lutetium-177-PSMA Radioligand Therapy for Advanced Salivary Gland Cancer, a Phase II Pilot Study.

Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.

开始日期2020-05-26

申办/合作机构

Radboud University Medical Center

[+1]

100 项与 Lutetium-177-PSMA-I&T 相关的临床结果

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100 项与 Lutetium-177-PSMA-I&T 相关的转化医学

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100 项与 Lutetium-177-PSMA-I&T 相关的专利（医药）

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31

项与 Lutetium-177-PSMA-I&T 相关的文献（医药）

2024-06-01·Nuklearmedizin - NuclearMedicine

Global Research Output of Lutetium-177 PSMA in Prostate Cancer: Bibliometric and Altmetric Analyses

Article

作者: Mirzaei, Siroos ; Shahait, Mohammed ; Al-Rashdan, Rakan ; Al-Khawaldeh, Khaled ; Lee, Szeting ; Sathekge, Mike Machaba ; Abdlkadir, Ahmed Saad ; Al-Abdallat, Haneen ; Al-Ibraheem, Akram

Abstract Aim The integration of innovative radio-pharmaceutical agents targeting prostate-specific membrane antigen (PSMA) within nuclear medicine has transformed prostate cancer detection and management. This study aims to investigate the present landscape of [177Lu]Lu-PSMA in prostate cancer, elucidating trends, global contributions, scholarly outlets, institutions, and thematic concentrations with an aim to inform forthcoming research endeavors. Methods We systematically probed the Scopus repository for relevant [177Lu]Lu-PSMA literature. An assessment of bibliometric and altmetric data was carried out. Finally, we assessed the correlation between the altmetric attention scores and the number of citations for the retrieved data. Results Spanning January 2015 to July 2023, the study encompassed 466 articles concerning [177Lu]Lu-PSMA therapy for prostate cancer. Predominant citation accolades gravitated towards metastatic castration-resistant prostate cancer investigations and assessments of [177Lu]Lu-PSMA therapy’s safety and efficacy. Further research encompassed adverse effects linked to [177Lu]Lu-PSMA intervention, including xerostomia, thrombocytopenia, anemia, and fatigue. Germany emerged as the primary academic contributor, with The Journal of Nuclear Medicine dominating publications (n = 55). A moderate significant correlation was detected between the number of citations and altmetric attention scores . Conclusion The findings highlight the growing interest and advancements in the utilization of [177Lu]Lu-PSMA therapy in prostate cancer and offer a comprehensive global perspective on future research directions.

2024-01-01·Theranostics

Lutetium-177-PSMA therapy for recurrent/metastatic salivary gland cancer: a prospective pilot study

Article

作者: Driessen, Chantal M.L. ; Konijnenberg, Mark W ; Gotthardt, Martin ; Privé, Bastiaan M ; van Herpen, Carla M.L. ; van Ruitenbeek, Niels J. ; van Herpen, Carla M L ; Peters, Steffie M.B. ; Nagarajah, James ; van Engen-van Grunsven, Adriana C H ; Uijen, Maike J M ; Privé, Bastiaan M. ; van Ruitenbeek, Niels J ; Peters, Steffie M B ; van Engen-van Grunsven, Adriana C.H. ; Konijnenberg, Mark W. ; Uijen, Maike J.M. ; Driessen, Chantal M L

There is an urgent need for novel systemic therapies for recurrent/systemic salivary gland cancer, as current treatment options are scarce. [⁶⁸Ga]Ga-PSMA-11 PET/CT revealed relevant uptake of prostate-specific membrane antigen (PSMA) in adenoid cystic carcinoma (AdCC) and salivary duct carcinoma (SDC). Therefore, we assessed the safety, feasibility, efficacy and radiation dosimetry of [¹⁷⁷Lu]Lu-PSMA-I&T treatment in AdCC and SDC patients in a prospective pilot study. Methods: This single-center, single-arm study intended to include 10 recurrent/metastatic AdCC patients and five recurrent/metastatic SDC patients. AdCC patients could only participate in case of progressive and/or symptomatic disease. Patients required ≥ 1 lesion ≥ 1.5 cm with an SUV_max on [⁶⁸Ga]Ga-PSMA-11 PET/CT above liver SUV_mean. Patients were planned to receive four cycles ~ 7.4 GBq [¹⁷⁷Lu]Lu-PSMA-I&T. In case of progressive disease per RECIST 1.1 at mid-treatment evaluation after two cycles, treatment was discontinued. Safety was the primary endpoint. Secondary endpoints included objective response rate (ORR), tumor- and organ-absorbed radiation doses and progression-free survival. Results: After screening, 10 out of 15 (67%) AdCC and two out of 10 (20%) SDC patients were eligible. Two patients (17%) demonstrated grade 3 treatment-related toxicity: lymphocytopenia (8%) and hyponatremia (8%). No dose-limiting toxicities occurred. In the AdCC cohort, six patients (60%) completed the four treatment cycles. Due to progressive disease, treatment was discontinued after two cycles in three patients (30%) and after one cycle in one patient (10%). No objective responses were observed (ORR: 0%). Three AdCC patients (30%) showed stable disease ≥ 6 months (7, 17 and 23 months). None of the two SDC patients completed the treatment: one patient deteriorated after the first cycle, while the other had progressive disease after two cycles. The high screen failure rate due to insufficient PSMA uptake resulted in premature closure of the SDC cohort. Dosimetry revealed low tumor-absorbed doses (median 0.07 Gy/GBq, range 0.001-0.63 Gy/GBq). Conclusions: [¹⁷⁷Lu]Lu-PSMA-I&T in AdCC and SDC patients was safe and generally well-tolerated. However, efficacy was limited, likely due to low tumor-absorbed doses. For SDC, [¹⁷⁷Lu]Lu-PSMA-I&T appears unfeasible due to insufficient PSMA uptake.

2023-07-01·European Urology Open Science

AR and PI3K Genomic Profiling of Cell-free DNA Can Identify Poor Responders to Lutetium-177-PSMA Among Patients with Metastatic Castration-resistant Prostate Cancer

Article

作者: Üstmert, Sezgin ; Maes, Alex ; Lesage, Karl ; Van Bos, Eva ; Lavent, Filip ; Vanwelkenhuyzen, Jan ; Lindberg, Johan ; Beels, Laurence ; Ost, Piet ; Grönberg, Henrik ; De Laere, Bram ; Van Bruwaene, Siska

Lutetium-177 prostate-specific membrane antigen radioligands (¹⁷⁷Lu-PSMA) are new therapeutic agents for the treatment of metastatic castration-resistant prostate cancer (mCRPC). We evaluated the prognostic value of circulating tumour DNA (ctDNA) profiling in patients with mCRPC starting treatment with ¹⁷⁷Lu-PSMA I&T. Between January 2020 and October 2022, patients with late-stage mCRPC (n = 57) were enrolled in a single-centre observational cohort study. Genomic alterations in the AR gene, PI3K signalling pathway, TP53, and TMPRSS2-ERG were associated with progression-free survival (PFS) on Kaplan-Meier and multivariable Cox regression analyses. Median PFS of 3.84 mo (95% confidence interval [CI] 3.3-5.4) was observed, and 21/56 (37.5%) evaluable patients experienced a prostate-specific antigen response of ≥50% during treatment. Among 46 patients who provided a blood sample for profiling before ¹⁷⁷Lu-PSMA treatment. ctDNA was detected in 39 (84.8%); higher ctDNA was correlated with shorter PFS. Genomic structural rearrangements in the AR gene (hazard ratio [HR] 9.74, 95% confidence interval [CI] 2.4-39.5; p = 0.001) and alterations in the PI3K signalling pathway (HR 3.58, 95% CI 1.41-9.08; p = 0.007) were independently associated with poor ¹⁷⁷Lu-PSMA prognosis on multivariable Cox regression. Prospective evaluation of these associations in biomarker-driven trials is warranted.Patient summaryWe examined cell-free DNA in blood samples from patients with advanced metastatic prostate cancer who started treatment with lutetium-177-PSMA, a new radioligand therapy. We found that patients with genetic alterations in the androgen receptor gene or PI3K pathway genes did not experience a lasting benefit from lutetium-177-PSMA.

100 项与 Lutetium-177-PSMA-I&T 相关的药物交易

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研发状态

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
前列腺癌	临床2期	-	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori SRL	2023-06-07
涎腺导管癌	临床2期	荷兰	Radboud University Medical Center	2020-05-26
腺样囊性癌	临床2期	-	Radboud University Nijmegen	-
唾液腺肿瘤	临床2期	-	Radboud University Nijmegen	-

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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


ASCO2023	N/A	转移性去势抵抗性前列腺癌	51	lutetium-177-PSMA-617 (Lu-177) (Hgb ≤10 g/dL or received RBC Tx)	憲鏇淵膚艱廠膚襯鏇觸(構鹽選夢選獵遞獵艱淵) = 構廠憲膚簾鬱選膚鏇獵窪鹽襯醖繭選醖獵膚簾 (襯壓醖鹹淵製夢壓製範, 4.43 ~ NA)	-	2023-05-31