A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients With High Risk Primary Prostate Cancer or Biochemical Recurrence After Radical Treatment (PRONOUNCED Study)

This will be an open-labelled, single centre study in the UK. The study group will include 60 patients with three groups of patients being studied. Group A will consist of 20 patients who have been newly diagnosed with primary high risk prostate cancer and are scheduled for radical prostatectomy surgery. Group B will consist of 20 patients with a diagnosis of BCR with previous radical prostatectomy, and are being considered for radical salvage therapy. Group C will consist of 20 patients with a diagnosis of BCR with previous radical radiotherapy (but no surgery), and are being considered for radical salvage therapy.

开始日期2018-06-18

申办/合作机构

Theragnostics Ltd.初创企业

EUCTR2017-005010-59-GB / Not yet recruiting临床2期

A Phase II, Open-label Study to Assess Safety and Clinical Utility of 68Ga-THP-PSMA PET/CT in Patients with High Risk Primary Prostate Cancer or Biochemical Recurrence after Radical treatment

开始日期2018-05-17

申办/合作机构

Theragnostics Ltd.初创企业

100 项与 Gallium-68-THP PSMA 相关的临床结果

登录后查看更多信息

100 项与 Gallium-68-THP PSMA 相关的转化医学

登录后查看更多信息

100 项与 Gallium-68-THP PSMA 相关的专利（医药）

登录后查看更多信息

项与 Gallium-68-THP PSMA 相关的文献（医药）

2023-10-01·Cancer science

Promotion of squamous cell carcinoma tumorigenesis by oncogene-mediated THG-1/TSC22D4 phosphorylation.

Article

作者: Kato, Mitsuyasu ; Kato, Yukinari ; Goto, Nohara ; Watanabe, Yukihide ; Suzuki, Hiroyuki ; Okano, Yasuhito ; Okita, Yukari ; Zheng, Ling

Carcinoma cells possess high proliferative and invasive potentials and exhibit a resilience against stresses, metabolic disorder, and therapeutic efforts. These properties are mainly acquired by genetic alterations including driver gene mutations. However, the detailed molecular mechanisms have not been fully elucidated. Here, we provide a novel mechanism connecting oncogenic signaling and the tumorigenic properties by a transforming growth factor-β1-stimulated clone 22 (TSC-22) family protein, THG-1 (also called as TSC22D4). THG-1 is localized at the basal layer of normal squamous epithelium and overexpressed in squamous cell carcinomas (SCCs). THG-1 knockdown suppressed SCC cell proliferation, invasiveness, and xenograft tumor formation. In contrast, THG-1 overexpression promoted the EGF-induced proliferation and stratified epithelium formation. Furthermore, THG-1 is phosphorylated by the receptor tyrosine kinase (RTK)-RAS-ERK pathway, which promoted the oncogene-mediated tumorigenesis. Moreover, THG-1 involves in the alternative splicing of CD44 variants, a regulator of invasiveness, stemness, and oxidative stress resistance under the RTK pathway. These findings highlight the pivotal roles of THG-1 as a novel effector of SCC tumorigenesis, and the detection of THG-1 phosphorylation by our established specific antibody could contribute to cancer diagnosis and therapy.

2021-12-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine1区 · 医学

A Phase II, Open-Label Study to Assess Safety and Management Change Using ⁶⁸Ga-THP PSMA PET/CT in Patients with High-Risk Primary Prostate Cancer or Biochemical Recurrence After Radical Treatment: The PRONOUNCED Study

1区 · 医学

Article

作者: Mitra, Anita ; Orczyk, Clement ; Meagher, Marie ; Payne, Heather ; Mullen, Greg ; Cook, Gary J R ; Afaq, Asim ; Kelkar, Anand ; Warbey, Victoria S ; Needleman, Sarah ; Ferris, Michael ; Davda, Reena ; Priftakis, Dimitrios ; Hines, John ; Bomanji, Jamshed

Objectives: To assess the safety and clinical impact of a novel, kit-based formulation of ⁶⁸Ga-THP PSMA positron emission tomography/computed tomography (PET/CT) when used to guide the management of patients with prostate cancer (PCa). Methods: Patients were prospectively recruited in to one of: Group A: high-risk untreated prostate cancer; Gleason score >4+3, or PSA >20 ng/mL or clinical stage >T2c. Group B: biochemical recurrence (BCR) and eligible for salvage treatment after radical prostatectomy with two consecutive rises in prostate specific antigen (PSA) with a three month interval in between reads and final PSA >0.1 ng/mL or a PSA level >0.5 ng/mL. Group C: BCR with radical curative radiotherapy or brachytherapy at least three months prior to enrolment, and an increase in PSA level >2.0 ng/mL above the nadir level after radiotherapy or brachytherapy. Patients underwent evaluation with PET/CT 60 minutes following intravenous administration of 160±30 MBq of ⁶⁸Ga-THP PSMA. Safety was assessed by means including vital signs, cardiovascular profile, serum haematology, biochemistry, urinalysis, PSA, and Adverse Events (AEs). A change in management was reported when the predefined clinical management of the patient altered as a result of ⁶⁸Ga-THP PSMA PET/CT findings. Results: Forty-nine patients were evaluated with PET/CT; 20 in Group A, 21 in Group B and 8 in Group C. No patients experienced serious AEs discontinued the study due to AEs, or died during the study. Two patients had Treatment Emergent AEs attributed to ⁶⁸Ga-THP-PSMA (pruritus in one patient and intravenous catheter site rash in another). Management change secondary to PET/CT occurred in 42.9% of all patients; 30% in Group A, 42.9% in Group B and 75% in Group C. Conclusion: ⁶⁸Ga-THP PSMA was safe to use with no serious AE and no AE resulting in withdrawal from the study. ⁶⁸Ga-THP PSMA PET/CT changed the management of patients in 42.9% of the study population, comparable to studies using other PSMA tracers. These data form the basis of a planned Phase III study of ⁶⁸Ga-THP PSMA in patients with prostate cancer.

2019-12-01·Journal of nuclear medicine technology

Current Status of Radionuclide Renal Cortical Imaging in Pyelonephritis

Review

作者: Sarikaya, Ali ; Sarikaya, Ismet

Pyelonephritis is an infection of the kidneys that is seen more commonly in children than the adults. ^99mTc-dimercaptosuccinic acid (^99mTc-DMSA) scanning is a radionuclide imaging study to detect renal scarring after acute pyelonephritis (a late ^99mTc-DMSA scan) and also helps to diagnose acute pyelonephritis in febrile urinary tract infections (an acute ^99mTc-DMSA scan). Planar imaging in multiple views (posterior and bilateral posterior oblique) is generally used. Pinhole imaging with a high-resolution-collimator magnification of each kidney allows detection of smaller cortical defects. SPECT is optional. SPECT/CT is not recommended in children because it has a higher radiation exposure than routine ^99mTc-DMSA scans. The main limitations of ^99mTc-DMSA scanning include a relatively long waiting time after radiotracer injection, a long acquisition time, and a high radiation dose, which is particularly important in repeated studies on children and with the limited spatial resolution of γ-cameras. ^99mTc-glucoheptonate is an alternative radiotracer when ^99mTc-DMSA is not available. Radiotracers for dynamic renal functional imaging can grossly assess the renal cortex in the first few minutes of imaging. ⁶⁸Ga-prostate-specific membrane antigen ligand (⁶⁸Ga-PSMA ligand) PET has the ability to provide images of normal renal cortex and demonstrate renal cortical defects from cysts. In this article, we assess the current status of renal cortical imaging and present ⁶⁸Ga-PSMA ligand PET images. ⁶⁸Ga-PSMA ligand provides excellent renal cortical images, and studies should be done to compare ⁶⁸Ga-PSMA ligand PET with ^99mTc-DMSA scanning in renal diseases, particularly in pyelonephritis.

项与 Gallium-68-THP PSMA 相关的新闻（医药）

2023-03-16

·PRNewswire

FDA Approves Expanded Indication for Telix's Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy

MELBOURNE, Australia, March 16, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom 177Lu 177 PSMA-directed therapy is indicated.[1] The label expansion means Illuccix is now approved in the U.S. to select patients who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA)- directed radioligand therapy (Pluvicto®),[2] providing doctors with critical information to help optimise and guide treatment decisions. To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent.[3] As the only diagnostic agent for suspected metastatic and recurrent prostate cancer that combines the accuracy of gallium imaging with the reliability and flexibility of Telix's distribution network, the expanded indication for Illuccix has the potential to improve access to imaging for patients who are candidates for radioligand therapy. Kevin Richardson, Chief Executive Officer for Telix Americas said, "We welcome the FDA's decision to expand the label indication for Illuccix. This additional indication further demonstrates our continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them. Clinicians now have the ability to use Illuccix in more stages of the patient journey, to confidently and accurately detect and help manage this disease." Use of Illuccix in the VISION Phase III study (ClinicalTrials.gov Identifier: NCT03511664)[4] helped doctors detect prostate cancer and identify the appropriate patients for PSMA-based radioligand therapy. Telix wishes to acknowledge collaboration with Novartis to deliver this outcome to patients. Dr Oliver Sartor, Medical Director at Tulane Cancer Center, added, "As radioligand therapy for prostate cancer becomes more prevalent, it is critical for doctors to understand who may or may not respond to those treatments. There's no doubt that appropriate selection of patients for PSMA targeted radioligand therapy is dependent on appropriate imaging. Ga-68 PSMA-11 PET was used in the VISION trial and, when used in combination with contrast-enhanced CT, represents a powerful tool for detecting prostate cancer and helping guide patient management." It is estimated that 32,000 patients per year in the U.S. may be considered for PSMA-directed radioligand therapy.[5] About Illuccix Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients 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; for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit and follow Telix on Twitter (@TelixPharma) and LinkedIn. Telix's lead product, Illuccix, has been approved by the FDA,[6] and by the Australian Therapeutic Goods Administration (TGA),[7] and by Health Canada.[8] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: [email protected] Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. ©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). Logo - SOURCE Telix Pharmaceuticals Limited

临床3期上市批准

100 项与 Gallium-68-THP PSMA 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

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	英国	Theragnostics Ltd.初创企业	2018-06-18

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


IAEA-PSMA (ASCO2021)	临床3期	复发性前列腺癌	1,198	Gallium-68 prostate-specific membrane antigen (PSMA) PET/CT imaging (68Ga-PSMA PET/CT)	繭齋獵醖觸衊顧鹽醖醖(構壓鏇衊鹹蓋糧獵構糧) = 襯艱醖築選遞憲鑰夢範繭願憲簾顧艱窪衊壓憲 (顧淵餘鏇鏇積膚積憲鏇 )	-	2021-05-28
Cold Kit PSMA Imaging (SNMMI2017)	N/A	前列腺癌 Gleason score \| PSA	14	68Ga-THP-PSMA68 Ga-THP-PSMA (68Ga-THP-PSMA)	積鏇鹽襯觸窪築簾觸簾(膚鬱蓋願齋觸艱積遞膚) = No adverse events occurred 艱糧願艱鏇淵鹹壓膚衊 (襯獵蓋願廠願鏇構憲夢 )	积极	2017-05-24
				68Ga-HBED-PSMA
ASCO2015	N/A	非转移性前列腺癌	332	<sup>68</sup>Gallium-labelled ligand of prostate-specific membrane antigen (<sup>68</sup>Ga-HBED-PSMA) (<sup>68</sup>Ga-HBED-PSMA-PET/CT)	鬱壓壓鑰襯願遞構觸積(遞顧簾廠鹹築選醖艱窪) = 齋襯蓋鬱製網鹽壓繭壓衊醖鹽憲窪範構壓鹹壓 (壓鬱鑰鬱範廠鏇鑰廠顧 )	-	2015-05-20
				<sup>68</sup>Gallium-labelled ligand of prostate-specific membrane antigen (<sup>68</sup>Ga-HBED-PSMA) (<sup>68</sup>Ga-HBED-PSMA-PET/MR)	鬱壓壓鑰襯願遞構觸積(遞顧簾廠鹹築選醖艱窪) = 積襯蓋醖願願遞窪餘製衊醖鹽憲窪範構壓鹹壓 (壓鬱鑰鬱範廠鏇鑰廠顧 )