Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in primary sjogren's syndrome patients.
Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [68Ga]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [68Ga]Ga-PSMA-11.
An Open-label, Multi-center, Randomized, Phase II Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer
The purpose of this study is to evaluate the efficacy of [177Lu]Lu-PSMA-617 over a change of androgen receptor-directed therapy (ARDT) treatment in prolonging radiographic progression free survival (rPFS) in Chinese metastatic castration-resistant prostate cancer patients, who were previously treated with another ARDT as last treatment and who have not been exposed to a taxane-containing regimen in castrate resistant prostate cancer (CRPC) or hormone-sensitive prostate cancer (HSPC) settings and who are considered appropriate for delaying taxane-based chemotherapy. The primary endpoint of rPFS will be assessed via blinded independent centralized review of radiographic images provided by the treating physician and as outlined in Prostate Cancer Working Group 3 (PCWG3) guidelines.
2023-10-11·European journal of nuclear medicine and molecular imaging
Total-body PET/CT with half-dose [68 Ga]Ga-PSMA-11 for biochemical recurrent prostate cancer: comparable diagnostic value to short axial field-of-view PET/CT with full-dose [68 Ga]Ga-PSMA-11.
作者: Yuheng Liu ; Lianghua Li ; Yanyu Qin ; Zijun Chen ; Haitao Zhao ; Xinlu Wang ; Ruohua Chen
The objective of this study was to evaluate the diagnostic performance and image quality of total-body positron emission tomography/computed tomography (PET/CT) imaging using a half-dose of [68 Ga]Ga-prostate specific membrane antigen ([68 Ga]Ga-PSMA) radiotracer, compared to conventional short axial field-of-view PET/CT imaging using a full dose of [68 Ga]Ga-PSMA.
This retrospective study enrolled 52 patients with biochemical recurrent (BCR) prostate cancer after radical prostatectomy who underwent total-body PET/CT with a half-dose (0.9-1.1 MBq/kg) of [68 Ga]Ga-PSMA. These patients were matched by baseline characteristics to another 52 BCR patients after prostatectomy who underwent conventional PET/CT with a full dose (1.8-2.2 MBq/kg) of [68 Ga]Ga-PSMA. The half-dose group was further divided into 5-min (G5) and 2-min (G2) acquisition subgroups. Image quality was assessed through subjective analysis using a 5-point scale and objective measurements of standard uptake value maximum (SUVmax), standard uptake value mean (SUVmean), background variation (BV) of the liver, blood pool, and parotid glands. Additionally, SUVmax and tumor-to-background ratio (TBR) were calculated for lesions.
No significant difference in subjective image quality was found between the G2 and full-dose groups (p > 0.05). PET/CT image quality was significantly higher for the G5 versus G2 (p < 0.001) and full-dose groups (p < 0.001). TBR did not differ between the G2 and full-dose groups (4.23 ± 5.21 vs 4.22 ± 3.97, p = 0.99). Liver BV was significantly lower for G2 versus full-dose groups (0.16 ± 0.03 vs 0.20 ± 0.05, p < 0.001).
Total-body PET/CT with a half-dose [68 Ga]Ga-PSMA yields image quality superior or comparable to that of conventional PET/CT. The utilization of total-body [68 Ga]Ga-PSMA PET/CT meets the diagnostic demands of BCR patients, particularly those who exhibit reduced tolerance to prolonged horizontal positioning and scan durations, while simultaneously reducing radiation exposure for the subjects.
2023-10-04·European journal of nuclear medicine and molecular imaging
Comparison of parametric imaging and SUV imaging with [68 Ga]Ga-PSMA-11 using dynamic total-body PET/CT in prostate cancer.
作者: Ruohua Chen ; Yee Ling Ng ; Xinlan Yang ; Yinjie Zhu ; Lianghua Li ; Haitao Zhao ; Yun Zhou ; Gang Huang ; Jianjun Liu
Standardized uptake value (SUV) has been prevalently used to measure [68 Ga]Ga-PSMA-11 activity in prostate cancer, but it is susceptible to multiple factors. Parametric imaging allows for absolute quantification of tracer uptake and provides a better diagnostic accuracy that is crucial for lesion detection. However, the clinical significance of total-body parametric imaging of [68 Ga]Ga-PSMA-11 remains to be fully assessed. Therefore, the aim of our study is to delve into the diagnostic implications of total-body parametric imaging of [68 Ga]Ga-PSMA-11 PET/CT for patients with prostate cancer.
Twenty prostate cancer patients were included and underwent a dynamic total-body [68 Ga]Ga-PSMA-11 PET/CT scan. An irreversible two-tissue compartment model (2T3k) was fitted for each tissue time-to-activity curve, and the net influx rate (Ki) was obtained. The image quality and semi-quantitative analysis of lesion-to-background ratio (LBR), signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) were compared between parametric images and SUV images.
Kinetic modeling using 2T3k demonstrated favorable model fitting in both normal organs and lesions. All of the lesions detected on SUV images (55-60 min) could be detected on Ki images. The correlation between Ki, SUVmean, and SUVmax in both normal organs and pathological lesions was found to be positive and statistically significant. Conversely, a moderate positive correlations were found between Ki and K1 (R = 0.69, P < 0.001; R = 0.61, P < 0.001) and Ki and k3 (R = 0.69, P < 0.001; R = 0.62, P < 0.001), in normal organs and pathological lesions, respectively. Visual assessment in Ki images showed less image noise and higher lesions conspicuity compared to SUV images. Ki image-derived LBR, SNR, and CBR of pathological lesions including primary tumors (PTs), lymph node metastases (LNMs) and bone metastases (BMs), exhibited remarkably higher folds (1.4-3.6 folds) compared to those derived from SUV of corresponding lesions.
Total-body parametric imaging of [68 Ga]Ga-PSMA-11 enhanced lesion contrast and improved lesion detectability compared to SUV images. This may potentially serve as an imaging biomarker and theranostic tool for precise diagnosis and treatment evaluation in prostate cancer patients.
2023-08-14·European journal of nuclear medicine and molecular imaging
Total-body [68 Ga]Ga-PSMA-11 PET/CT improves detection rate compared with conventional [68 Ga]Ga-PSMA-11 PET/CT in patients with biochemical recurrent prostate cancer.
作者: Yining Wang ; Zijun Chen ; Yinjie Zhu ; Haitao Zhao ; Lianghua Li ; Gang Huang ; Wei Xue ; Ruohua Chen ; Jianjun Liu
The purpose of this study was to assess whether total-body [68 Ga]Ga-PSMA-11 PET/CT could improve the detection rate compared with conventional [68 Ga]Ga-PSMA-11 PET/CT in patients with biochemical recurrent prostate cancer.
Two hundred biochemical recurrent prostate cancer patients with similar clinicopathological characteristics were included, of whom 100 patients underwent early total-body [68 Ga]Ga-PSMA-11 PET/CT and diuretic-delayed total-body [68 Ga]Ga-PSMA-11 PET/CT, and the other 100 patients received early conventional [68 Ga]Ga-PSMA-11 PET/CT and diuretic-delayed conventional [68 Ga]Ga-PSMA-11 PET/CT. The detection rates of total-body [68 Ga]Ga-PSMA-11 PET/CT and conventional [68 Ga]Ga-PSMA-11 PET/CT were compared using a chi-square test and stratified analysis. The image quality of total-body [68 Ga]Ga-PSMA PET/CT and conventional [68 Ga]Ga-PSMA-11 PET/CT was compared based on subjective scoring and objective parameters. Subjective scoring was conducted from background noise and lesion prominence using a 5-point scale. Objective parameters were evaluated by SUVmax, SUVmean, the standard deviation (SD) of SUV, and the signal-to-noise ratio (SNR) of liver and gluteus maximus. The SUVmax of the recurrent lesions was also measured.
The liver SD of the total-body [68 Ga]Ga-PSMA-11 PET/CT was significantly lower than that of conventional [68 Ga]Ga-PSMA-11 PET/CT, the SNR was significantly higher than that of conventional [68 Ga]Ga-PSMA-11 PET/CT, and the subjective evaluation was significantly better than that of conventional [68 Ga]Ga-PSMA-11 PET/CT. The detection rate of total-body [68 Ga]Ga-PSMA PET/CT for biochemical recurrence of prostate cancer was significantly higher than that of conventional [68 Ga]Ga-PSMA-11 PET/CT (91.0% vs. 74.0%, P = 0.003). Total-body [68 Ga]Ga-PSMA-11 PET/CT had better detection efficiency for patients with a Gleason score ≤ 8 or PSA ≤ 2 ng/ml. The advantages of diuretic-delayed total-body [68 Ga]Ga-PSMA-11 PET/CT were more obvious.
Total-body [68 Ga]Ga-PSMA-11 PET/CT could significantly improve the detection rate compared with conventional [68 Ga]Ga-PSMA-11 PET/CT in patients with biochemical recurrent prostate cancer.
MELBOURNE, Australia and PORTO ALEGRE, Brazil, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘Anvisa’) has granted an exceptional authorisation for Illuccix® (TLX591-CDx) the Company’s lead prostate cancer imaging product.
Illuccix (Kit for the preparation of 68Ga PSMA-11 Injection) is a positron emission tomography (PET) imaging agent targeting prostate specific membrane antigen (PSMA) for the staging of prostate cancer. The exceptional authorisation grants permission to commence selling Illuccix in Brazil, ahead of a full regulatory approval, expected next year.
The authorisation is granted to Telix’s partner MJM Produtos Farmacêuticos e de Radioproteção LTDA (Grupo RPH), Brazil’s leading cold kit plant and radiopharmacy network. RPH has an exclusive licence agreement with Telix to manufacture and distribute Illuccix in Brazil.1
The Anvisa approval facilitates wide-spread clinical access to state-of-the-art prostate cancer imaging for all men across Brazil, a large and rapidly growing market for gallium-68 based radiopharmaceuticals.
Dr. Christian Behrenbruch, CEO and Managing Director of Telix said, “Prostate cancer is the most commonly diagnosed male cancer in Brazil, with approximately 65,840 new cases each year.2 PSMA-PET imaging has the potential to have a profound impact on the management of prostate cancer, enabling clinicians to detect prostate cancer right throughout the body. We look forward to working closely with our partner RPH to facilitate widespread patient access to Illuccix for men living with prostate cancer in Brazil.”
Grupo RPH Nuclear Medicine & Innovation Vice-President, Rafael Madke, added, “We are very pleased to have received this exceptional authorisation for Illuccix in Brazil, which is only given in select circumstances, and we look forward to playing an important role in transforming outcomes for men with prostate cancer. Grupo RPH is pleased to be working with a global leader such as Telix. We have extensive capability to manufacture and distribute nuclear medicine products in this region, and our objectives to support physicians and patients in Brazil are closely aligned.”
Illuccix (TLX591-CDx) is a preparation for imaging prostate cancer with positron emission tomography (PET), targeting prostate specific membrane antigen (PSMA), a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix enables PSMA-11 to be labelled with the radionuclide Ga-68 directly before injection by medical professionals. After preparing the radiopharmaceutical and injecting it into the patient, PSMA positive lesions are localised by PET imaging.
Illuccix (TLX591-CDx) for prostate cancer imaging, has been approved by the Australian Therapeutic Goods Administration (TGA),3 and accepted for filing by the U.S. Food and Drug Administration (FDA).4 Telix is also progressing marketing authorisation applications for Illuccix in the European Union5 and Canada.6
About Prostate Cancer in Brazil
In 2020, prostate cancer was the most commonly diagnosed male cancer in Brazil with approximately 65,840 new cases per year. Prostate cancer was also the second most common cause of cancer death in men (after lung cancer), with more than 18,000 men dying from their disease in 2020. More than 320,000 men in Brazil were estimated to be living with prostate cancer in 2020.7
About Grupo RPH
Operating since 2004, Grupo RPH commercially delivers eight different Cold Kits for 99mTc and 68Ga preparation for the Brazilian market. Grupo RPH is also the proud owner of the only private-owned fully GMP production facility in Brazil for nuclear medicine products. Grupo RPH’s products are sold throughout the whole Brazilian territory, serving nearly 400 customers on a daily basis. Grupo RPH is also a pioneer of the centralized radiopharmacy model in Brazil. For more information visit:
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Switzerland, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that 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.
With the exception of Illuccix in Australia, none of Telix’s products have received a marketing authorisation in any jurisdiction. In Brazil, Illuccix has been granted exceptional authorisation.
Telix Media Contact
Dr. Stewart Holmstrom
Telix Pharmaceuticals Limited
Director Corporate Communications
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not beenandwillnotberegisteredundertheUnitedStatesSecuritiesActof1933(the“U.S.SecuritiesAct”),orunderthe securitieslawsofanystateorotherjurisdictionoftheUnitedStatesandmaynotbeofferedorsoldwithintheUnited States,unlessthesecuritieshavebeenregisteredundertheU.S.SecuritiesActoranexemptionfromtheregistration requirements of the U.S. Securities Act isavailable. None of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. This announcement has been authorised for release by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer. The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).
1 ASX disclosure 03/07/19.
2 Brazilian Cancer Institute.
3 ASX disclosure 02/11/21.
4 ASX disclosure 24/11/20.
5 ASX disclosure 01/05/20.
6 ASX disclosure 16/12/20.
7 Globocan 2021, Brazilian Cancer Institute.
BURNABY, British Columbia--(BUSINESS WIRE)-- ARTMS Inc. (ARTMS), the global leader in developing and commercializing novel products enabling cyclotron production of the world’s most needed medical radioisotopes, is pleased to announce the submission of a Type 1 Master File with the Health Products & Food Branch, Health Canada (HC) for the production of gallium-68 (Ga-68). Gallium-68 is a critical medical isotope of significant clinical importance in nuclear medicine diagnostic procedures utilizing Positron Emission Tomography (PET) imaging. ARTMS’ Health Canada filing will help alleviate the current supply constraints and provide innovators the ability to advance new radiopharmaceutical drugs into development.
On the basis of the filing, ARTMS has also entered into a tri-party co-operation with fellow industry leaders, POINT Biopharma (NASDAQ: PNT) and the Canadian Molecular Imaging Probe Consortium (CanProbe), a joint venture between the Centre for Probe Development and Commercialization (CPDC) and the University Health Network (UHN), for the development and clinical use of innovative radiopharmaceuticals in Canada.
“The Ga-68 regulatory filing in Canada is the next step in ARTMS’ goal to prevent the significant supply issues of this important medical isotope. The current supply chain of germanium/gallium generators is inefficient, high cost and at risk for interruption at any time. Any interruptions to the supply chain will negatively impact patients and drug innovators,” explained Charles S. Conroy, Chief Executive Officer of ARTMS. “Our collaborative working relationship with POINT and CanProbe will leverage ARTMS’ proprietary solid target approach to bring important new medicines to Canadians.“
“Increasing the availability and scale of Ga-68 supply through cyclotron production will be important in further accelerating the development and commercialization of next generation radiopharmaceutical therapies,” said Dr. Joe McCann, Chief Executive Officer of POINT Biopharma. “We believe ARTMS’ solid target approach to Ga-68 production will play a key role in increasing the availability of this important isotope. We are excited to work with ARTMS and CanProbe in the creation of POINT’s new Ga-based based molecular imaging agents that will enable the development and commercialization of our next generation radiopharmaceutical therapies.”
Dr. Bruno Paquin, President of CanProbe and CEO of CPDC, remarked, “Gallium-68 is the critical active component of many radiopharmaceuticals used in the diagnosis and staging of important medical conditions such as prostate cancer and neuroendocrine tumours.” Dr. Paquin further commented that, “ARTMS’ QUANTM Irradiation System enables our facility a 100-fold increase in the availability of Ga-68 over the current generator supply. This significant increase in isotope supply directly impacts our ability to work with innovators such as POINT to meet end-patient needs.”
ARTMS continues to drive nuclear medicine’s supply chain into the future through the QUANTM Irradiation System ecosystem by providing a pathway for large scale isotope production of Zr-89, Cu-64 and Tc-99m. Mr. Conroy concluded, “We will continue to support and work with radiopharmaceutical innovators to validate their products with the ARTMS system and have their regulatory filings reference ARTMS’ cyclotron solid target approaches.”
Based in Burnaby, British Columbia, Canada, ARTMS Inc. is a global leader in the development of novel technologies and products which enable the high-quality and high-yield production of the world’s most-used diagnostic imaging isotopes. ARTMS’ flagship product, the QUANTM Irradiation SystemTM (QISTM), enables decentralized, cost-effective, large-scale production of important medical isotopes such as gallium-68 (68Ga), zirconium-89 (89Zr), technetium‐99m (99mTc) and copper-64 (64Cu) using pharmaceutical distributor and hospital-based medical cyclotrons, empowering users to control their supply chain. ARTMS commercializes these award-winning and proprietary Canadian inventions on a global basis and has the prospect of revolutionizing the nuclear medicine industry.
For more information on the QUANTM Irradiation System™ and ARTMS, please follow us on Twitter @ARTMS_Inc and LinkedIn and visit .
About POINT Biopharma
POINT Biopharma Global Inc. (NASDAQ: PNT) is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT Biopharma Global Inc. is combining a portfolio of best-in-class radiopharmaceutical assets, a seasoned management team, expertise in radioisotopes such as Actinium-225 (Ac-225) and Lutetium-177 (Lu-177), and industry-leading manufacturing capabilities and supply chain, to revolutionize theragnostic drug development and radioligand commercialization. Learn more about POINT Biopharma Global Inc. at .
CanProbe is a joint venture between the Centre for Probe Development and Commercialization (CPDC) and University Health Network (UHN) to create a Canadian Centre of Excellence for the development, translation, utilization and commercialization of radiopharmaceuticals. CanProbe leverages the strengths of its partners and their affiliates. For more information about CanProbe, please visit: .
The Centre for Probe Development and Commercialization (CPDC) is a global leader in the discovery, development and commercialization of next generation radiopharmaceuticals supported by the Networks of Centres of Excellence (NCE), McMaster University and the Ontario Institute for Cancer Research (OICR). With an established pipeline of products and a robust and reliable manufacturing unit, CPDC supplies innovative diagnostic and therapeutic radiopharmaceuticals globally ( ).
University Health Network consists of Toronto General and Toronto Western Hospitals, the Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, and The Michener Institute of Education at UHN. The scope of research and complexity of cases at University Health Network has made it a national and international source for discovery, education and patient care. It has the largest hospital-based research program in Canada, with major research in arthritis, cardiology, transplantation, neurosciences, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. University Health Network is a research hospital affiliated with the University of Toronto.
MELBOURNE, Australia and INDIANAPOLIS, Sept. 13, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) has today welcomed the updated National Comprehensive Cancer Network® (NCCN) Guidelines® for prostate cancer,1 which includes prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging modalities, including Ga-68 PSMA-11.
Telix’s New Drug Application (NDA) for its investigational imaging product Illuccix® (Kit for the preparation of 68Ga-PSMA-11 injection) is in the late stages of review by the United States Food and Drug Administration. The NCCN Guidelines® are a recognised standard for clinical direction and policy in cancer care and are used widely by clinicians and payors.
The NCCN panel has recognised the increased sensitivity and specificity of PSMA-PET tracers, compared to conventional imaging (CT, MRI) for detecting micrometastatic disease, at both initial staging and biochemical recurrence. The updated guidelines state that the NCCN Panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as equally effective, if not more effective front-line imaging tools for these patients. The updated guidelines now include Ga-68 PSMA-11 PET/CT to be considered as an alternative to standard imaging of bone and soft tissue.
Dr Colin Hayward, Chief Medical Officer of Telix said, “This is an important change to the guidelines which will influence a shift in clinical practice to consider PSMA-PET imaging as an alternative to standard imaging of bone and soft tissue for the detection of unfavorable intermediate, high and very high risk as well as recurrent prostate cancer.”
“The NCCN guidelines are considered a global standard to guide oncology practice and reimbursement. The inclusion of PSMA-PET imaging, including with Ga-68, the isotope used in our investigational imaging product Illuccix® further signals the emergence of PSMA-PET imaging as a state-of-the-art imaging modality.”
Dr Oliver Sartor, Medical Director at Tulane Cancer Center said, “The updated guidelines will encourage clinicians to use PSMA-PET as a primary imaging modality in patients and will deliver the benefit of a more streamlined approach. We look forward to having access to this functional form of imaging as new products come into the market.”
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that 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 investigational product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,2 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).3 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union4 and Canada.5 None of Telix’s products have received a marketing authorisation in any jurisdiction.
Telix Media Contact
Dr. Stewart Holmstrom
Telix Pharmaceuticals Limited
Director Corporate Communications
2 ASX disclosure 24/11/20.
3 ASX disclosure 14/04/21.
4 ASX disclosure 1/05/20.
5 ASX disclosure 16/12/20.