Gallium-68 PSMA-617(Gallium-68 PSMA-617) - 药物靶点：PSMA_在研适应症：前列腺癌_专利_临床

概要

基本信息

药物类型

多肽偶联核素、诊断用放射药物

别名

+ [3]

靶点

PSMA

作用机制

PSMA抑制剂(前列腺癌特异性膜抗原抑制剂)、PET imaging(正电子发射断层成像术增强剂)

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

前列腺癌

非在研适应症-

原研机构

Ruprecht-Karls-Universität Heidelberg

在研机构

北京协和医院

Ruprecht-Karls-Universität Heidelberg

German Cancer Research Center

非在研机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)临床2/3期

特殊审评-

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结构

分子式C49H66GaN9O16

InChIKeyPAXMZYRHVDZFFV-VSVMWJISSA-I

CAS号2247839-19-4

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关联

5

项与 Gallium-68 PSMA-617 相关的临床试验

NCT06437496 / Recruiting早期临床1期IIT

68Ga-AAZTA-093 PET/CT: First-in-human Study in Patients With Prostate Cancer

68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer.

开始日期2024-04-01

申办/合作机构

福建医科大学附属第一医院

NCT05841992 / Recruiting临床2/3期IIT

Comparison of the Detection Efficiencies of Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT in Patients With Prostate Cancer

18F-labeled prostate-specific membrane antigen (PSMA) ligand-positron emission tomography (PET) offers advantages over 68Ga-labeled PSMA ligands. Al18F-PSMA-617 is a novel 18F-PSMA compound used for prostate cancer (PCa) imaging. This pilot study was prospectively designed to compare the lesion detectability of Al18F-PSMA-617 and related 68Ga-PSMA-617 PET/CT in patients with PCa

开始日期2021-07-01

申办/合作机构

北京协和医院

NCT04796467 / Recruiting临床2/3期IIT

A Pilot Prospective Comparison of 68Ga-P16-093 and 68Ga-PSMA-617 in the Same Group of Prostate Cancer Patients

Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the widely studied 68Ga-PSMA-617. This pilot study was prospectively designed to evaluate the early dynamic distribution of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.

开始日期2020-10-01

申办/合作机构

北京协和医院

100 项与 Gallium-68 PSMA-617 相关的临床结果

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100 项与 Gallium-68 PSMA-617 相关的转化医学

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100 项与 Gallium-68 PSMA-617 相关的专利（医药）

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15

项与 Gallium-68 PSMA-617 相关的文献（医药）

2023-04-01·Clinical Nuclear Medicine

Head-to-Head Comparison of 68Ga-P16-093 and 68Ga-PSMA-617 PET/CT in Patients With Primary Prostate Cancer

Article

作者: Hong, Haiyan ; Zang, Jie ; Kung, Hank F ; Wang, Guochang ; Zhu, Lin ; Zhu, Zhaohui ; Li, Linlin

PurposeWe aimed to compare the diagnostic performance of 68Ga-P16-093 and 68Ga-PSMA-617 PET/CT in primary prostate cancer (PCa) patients.Patients and MethodsThirty untreated primary PCa patients were enrolled. Each patient underwent 68Ga-P16-093 and 68Ga-PSMA-617 PET/CT within a week. In addition to visual analysis, SUV was measured for semiquantitative comparison and correlation analysis.Results68Ga-P16-093 PET/CT detected more positive tumors than 68Ga-PSMA-617 PET/CT (67 vs 56, P = 0.002), especially for intraprostatic lesions (29 vs 24, P = 0.025) and lymph node metastases (23 vs 17, P = 0.034). Further, 68Ga-P16-093 PET/CT exhibited significantly higher SUVmax of matched tumors (18.3 ± 14.4 vs 13.9 ± 11.8, P < 0.001). Besides, the SUVmax of high-risk patients (based on D’Amico classification) on 68Ga-P16-093 PET/CT was significantly higher than that of low- and intermediate-risk PCa patients (20.9 ± 9.9 vs 8.9 ± 9.1 vs 10.1 ± 5.2, P = 0.007). The SUVmax of tumor measured by 68Ga-P16-093 PET/CT had a moderate association with biopsy Gleason score (r = 0.462, P = 0.005) and prostate-specific antigen value (r = 0.491, P = 0.002), and significantly correlated with PSMA expression (r = 0.732, P < 0.001).Conclusions68Ga-P16-093 PET/CT exhibited higher tumor uptake and potentially better tumor detection capability than 68Ga-PSMA-617 PET/CT, which suggested that 68Ga-P16-093 may be more suitable in the diagnosis and staging of primary PCa patients.

2023-03-01·Journal of Nuclear Medicine

Comparison of⁶⁸Ga-PSMA-617 PET/CT and⁶⁸Ga-RM2 PET/CT in Patients with Localized Prostate Cancer Who Are Candidates for Radical Prostatectomy: A Prospective, Single-Arm, Single-Center, Phase II Study

Article

作者: Schollhammer, Romain ; Gallerande, Henri de Clermont ; Balamoutoff, Nicolas ; Robert, Grégoire ; Bladou, Franck ; Vimont, Delphine ; Asselineau, Julien ; Bénard, Antoine ; Morgat, Clément ; Yacoub, Mokrane ; Hindié, Elif

Considering the wide range of therapeutic options for localized prostate cancer (e.g., active surveillance, radiation-beam therapy, focal therapy, and radical prostatectomy), accurate assessment of the aggressiveness and localization of primary prostate cancer lesions is essential for treatment decision making. National Comprehensive Cancer Network guidelines recognize prostate-specific membrane antigen (PSMA) PET/CT for use in initial staging of high-risk primary prostate cancer. The gastrin-releasing peptide receptor (GRP-R) is a neuropeptide receptor overexpressed by low-risk prostate cancer cells. We aimed to perform the first (to our knowledge) prospective head-to-head comparison of PSMA- and GRP-R-targeted imaging at initial staging to understand how PSMA PET and GRP-R PET can be used or combined in clinical practice. Methods: This was a prospective, single-center, diagnostic cross-sectional imaging study using anonymized, masked, and independent interpretations of paired PET/CT studies in 22 patients with ⁶⁸Ga-PSMA-617 (a radiolabeled PSMA inhibitor) and ⁶⁸Ga-RM2 (⁶⁸Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, a radiolabeled GRP-R antagonist). We enrolled patients with newly diagnosed, biopsy-proven prostate cancer. None had received neoadjuvant hormone therapy or chemotherapy, and all underwent extended pelvic lymph node dissection. Histologic findings served as a reference. Results: On a lesion-based analysis (including lesions < 0.1 cm³), ⁶⁸Ga-PSMA-617 PET/CT detected 74.3% (26/35) of all tumor lesions and ⁶⁸Ga-RM2 PET/CT detected 78.1% (25/32; 1 patient could not be offered ⁶⁸Ga-RM2 PET/CT). Paired examinations showed positive uptake of the 2 tracers in 21 of 32 lesions (65.6%), negative uptake in 5 of 32 lesions (15.6%), and discordant uptake in 6 of 32 lesions (18.8%). Uptake of ⁶⁸Ga-PSMA-617 was higher when the International Society of Urological Pathology (ISUP) score was at least 4 versus at least 1 (P < 0.0001) or 2 (P = 0.0002). There were no significant differences in uptake between ISUP scores for ⁶⁸Ga-RM2. Median ⁶⁸Ga-RM2 SUV_max was significantly higher than median ⁶⁸Ga-PSMA-617 SUV_max in the ISUP-2 subgroup (P = 0.01). Conclusion: ⁶⁸Ga-PSMA-617 PET/CT is useful to depict higher, more clinically significant ISUP score lesions, and ⁶⁸Ga-RM2 PET/CT has a higher detection rate for low-ISUP tumors. Combining PSMA PET and GRP-R PET allows for better classification of intraprostatic lesions.

2021-10-01·Nuclear Medicine and Molecular Imaging

Patient-Specific Dosimetry in Radioligand Therapy (RLT) for Metastatic Prostate Cancer Using 177Lu-DKFZ-PSMA-617

Article

作者: Ghorbani, Mahdi ; Pirayesh, Elahe ; Amoui, Mahasti ; Rad, Mehrdad Ghorbani ; Mahmoudi, Elahe ; Deevband, Mohammad Reza

PURPOSE¹⁷⁷Lu-DKFZ-PSMA-617 is a promising treatment for patients with metastatic prostate cancer. Specific dosimetry for each patient is an important factor in planning the patient's treatment process. This study aimed to perform an image-based absorbed dose calculation for the treatment of metastatic prostate cancer with ¹⁷⁷Lu-DKFZ-PSMA-617.METHODSThe individualized patient dosimetry calculations were based on whole-body planar scintigraphy images acquired in 10 patients with a mean age of 71.4 ± 6.07 years (range 63-85 years) at approximately 0-2 h, 4-6 h, 18-24 h, and 36-48 h after administration of the mean 6253 ± 826.4 MBq (range 5500-7400 MBq) of ¹⁷⁷Lu-DKFZ-PSMA-617. Time-activity curves were generated for various organs. For count conversion to activities, calibration factors were calculated. Finally, the absorbed dose for an individual cycle was calculated using IDIAC-DOSE 2.1 software.RESULTSOn average, the calculated absorbed dose for the kidneys and salivary glands were 0.46 ± 0.09 mGy/MBq and 0.62 ± 0.07 mGy/MBq, respectively.CONCLUSIONSBased on the results, the¹⁷⁷Lu-PSMA-617 therapy is a safe method for the treatment of castration-resistant prostate cancer patients. Large inter-individual variations in organ dose were found, demonstrating the need for patient-specific dosimetry and treatment planning.

100 项与 Gallium-68 PSMA-617 相关的药物交易

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研发状态

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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3期	中国	北京协和医院	2020-10-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2020	N/A	-	-	68Ga-PSMA-617	構範淵膚網鏇遞醖膚顧(構網膚願鬱壓艱餘壓鑰) = 構淵鑰鹹艱窪構積積衊顧鑰築觸鏇網選鹹廠鑰 (夢鏇壓構範網蓋顧遞齋 ) 更多	-	2020-05-15
SNMMI2020	N/A	-	-	68 Ga-PSMA-61768Ga-PSMA-617 (Cyclotron-produced 68Ga-PSMA-617)	齋願鏇膚遞齋膚遞鏇獵(遞廠鑰衊廠齋簾遞壓遞) = >95% 廠製鬱齋網製窪餘夢積 (遞簾壓積餘餘醖選糧蓋 ) 更多	-	2020-05-15