Localized Prostate Carcinoma

LOS ANGELES, March 14, 2024 /PRNewswire/ -- The Prostate Cancer Foundation (PCF) today announced the 2023 Class of PCF Team Challenge Award recipients and a total of more than $21 million in funding for innovative prostate cancer research. PCF Challenge Awards fund international, multi-institutional, cross-disciplinary teams of investigators conducting highly innovative research with the greatest potential for accelerating new and improved treatments for advanced prostate cancer. Following a rigorous peer review process that assessed each project's scientific merit and potential patient impact, 20 highly coveted PCF Challenge Awards totaling $21.3 million were granted to teams at some of the world's leading cancer research institutions. For full project descriptions visit . 2023 James Cox Foundation, GTSN-PCF Challenge Award Project Title: Targeting Neuroendocrine Cells in Prostate Cancer with Small Molecule and Targeted Radionuclide Therapies Principal Investigators: Andrew Armstrong, MD, and Jiaoti Huang, MD, both of Duke University (Studying the efficacy of and developing biomarkers for two new treatment approaches for neuroendocrine prostate cancer to address an unmet need encompassing precision immunotherapy for the treatment of highly aggressive forms of castration-resistant prostate cancer.) 2023 Republic National Distributing Company (RNDC)-PCF Challenge Award Project Title: Development of a CBP/p300 Degrader for the Treatment of Castration-Resistant Prostate Cancer Principal Investigators: Arul Chinnaiyan, MD, PhD; Shaomeng Wang, PhD; Ulka Vaishampayan, MBBS; Abhijit Parolia, PhD, all of University of Michigan (Developing a new therapy that targets the prostate cancer oncogenes CBP and p300, this project will provide preclinical efficacy data and analyze biomarkers of response from a phase 1/2 clinical trials in patients with metastatic castration-resistant prostate cancer.) 2023 Bayer-PCF Health Equity Research Award Project Title: Incorporating Patient Education into Germline Testing in Black Patients with Prostate Cancer Principal Investigator: Burcu Darst, PhD, Fred Hutchinson Cancer Center (With the aim of reducing prostate cancer health disparities, this project will examine whether a tailored education program increases the likelihood of Black patients to undergo genetic testing and further the understanding of how this information impacts disease management decisions.) 2023 PCF Challenge Award Project Title: Personalizing Treatment Decisions Through Composite Next Generation Imaging and Liquid Biomarker Development Within a Phase II Randomized Trial of Enzalutamide (+/- 177Lu-PSMA-617) (ENZAp) Principal Investigator: Louise Emmett, MD, MBBS, St. Vincent's Hospital, Sydney, Australia (Studying molecular imaging and liquid biopsies from patients on a clinical trial testing LuPSMA plus enzalutamide versus enzalutamide alone as first-line therapy in patients with metastatic castration-resistant prostate cancer to better understand the mechanisms of synergy and resistance and develop biomarkers to guide individualized treatment decisions for patients.) 2023 Sun Pharma-PCF VAlor Special Challenge Award Project Title: A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans with Castrate-Sensitive Prostate Cancer Principal Investigators: Antonio Tito Fojo, MD, and Susan Bates, MD, both of James J. Peters Veterans Affair Medical Center (Studying the effectiveness of an abiraterone-first strategy in the management of patients with castration-sensitive prostate cancer at the time when cancer recurrence is first documented.) 2023 PCF Challenge Award Project Title: Identifying Drivers of Aggressive Prostate Cancer and Racial Disparities in Patients Presenting with Low-Grade Disease Principal Investigators: Vanessa Hayes, PhD, The University of Sydney; Gail Prins, PhD, University of Illinois at Chicago; Riana Bornman, MD, University of Pretoria (Identifying genetic and genomic risk factors of lethal prostate cancer in African ancestry patients and translating this information into new criteria for classifying, managing and treating prostate cancer in these patients in order to reduce racial health disparities.) 2023 Bayer-PCF Health Equity Research Award Project Title: Impact of Genetic Ancestry and DNA Methylation on Prostate Cancer in African and African-American Patients Principal Investigator: Brian Joyce, PhD, Northwestern University (Investigating the usefulness of DNA methylation profiling of patient samples for the early detection and risk stratification of prostate cancer in Black men.) 2023 John Black Charitable Foundation-PCF Challenge Award Project Title: Metabolic Imaging and Targeted Radionuclide Combination Treatment of Prostate Cancer Bone Metastases Principal Investigators: Edward O'Neill, PhD, Claire Edwards, PhD, both of University of Oxford (Studying the role of tumor metabolism in treatment responses to 177Lu-PSMA-617 radioligand therapy to identify potential biomarkers and therapeutic targets in advanced prostate cancer.) 2023 Bayer-PCF Health Equity Research Award Project Title: Molecular Evaluation of Prostate Saturation and Progression Biopsies for Risk Assessment and Early Intervention Principal Investigator: Nallasivam Palanisamy, PhD, MSc, Henry Ford Health System (Analyzing at the molecular level prostate tumor samples from Black and white patients to understand racial differences in prostate cancer biology and disease progression, potentially leading to improved biomarker-based risk assessment tools for Black patients to improve health outcomes and reduce disparities.) 2023 Digital Science Press-PCF Challenge Award Project Title: Intercepting the Cancer Endocycle to Cure Lethal Prostate Cancer Principal Investigators: Kenneth Pienta, MD, Johns Hopkins University; Sarah Amend, PhD, Johns Hopkins School of Medicine; Emma Hammarlund, PhD, Lund University (Investigating whether a dormant "endocycling" state underlies cancer cells' ability to survive and resist therapy and testing new therapies to target cancer cells in this state.) 2023 Bayer-PCF Darolutamide Challenge Award Project Title: Darolutamide to Augment Radiotheranostic Therapy in Biochemically Recurrent Prostate Cancer (DART-BCR) Principal Investigators: Praful Ravi, MD, Harvard: Dana-Farber Cancer Institute; David Einstein, MD, Beth Israel Deaconess Medical Center (Examining the efficacy of darolutamide alone or in combination with PSMA-targeted radioligand therapy to identify biomarkers for patients most likely to benefit from this combination therapy, and determining how PSMA, the target of prostate cancer treatments and PET imaging, is regulated.) 2023 Durden Foundation-PCF Challenge Award Project Title: Characterizing Imaging, Genomic and Immune Predictors of 177Lu-PSMA (Lu-PSMA) and Olaparib Response in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) Principal Investigators: Shaneen Sandhu, MBBS, and Belinda Parker, PhD, both of the University of Melbourne (Testing the efficacy of a combination of Lu-PSMA and Olaparib for certain patients with mCRPC and defining the biological impacts of this combined therapy to maximize its effectiveness.) 2023 John and Daria Barry Foundation-PCF VAlor Challenge Award Project Title: Germline Influence on Prostate Cancer Metastasis and Response to Androgen Deprivation Therapy Principal Investigators: Tyler Seibert, MD, PhD, and Rana McKay, MD, of University of California San Diego; and Paul Boutros, PhD, MBA, of University of California Los Angeles (Using previously identified genetic variants that increase prostate cancer aggressiveness to develop a new genetic test that can predict individuals at high risk for developing lethal prostate cancer and their response to treatment.) 2023 Hamptons Coalition-PCF Challenge Award Project Title: Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance in Metastatic Prostate Cancer Principal Investigators: Karen Sfanos, PhD, Johns Hopkins University; Cathy Marshall, MD, MPH, Mark Markowski, MD, PhD, both of Johns Hopkins Medicine; Jason Ridlon, PhD, University of Illinois Urbana-Champaign (Developing and testing therapeutic strategies to prevent androgen production by gut bacteria in order to prolong the clinical response to anti-androgen therapies.) 2023 Regeneron-PCF Special Challenge Award Project Title: A Pilot Presurgical Trial of REGN5678 (Anti-PSMAxCD28) in Patients with High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy Principal Investigators: Padmanee Sharma, MD, PhD, Sumit Subudhi, MD, PhD, Brian Chapin, MD, Bilal Siddiqui, MD, all of The University of Texas MD Anderson Cancer Center (Investigating the efficacy of a new immunotherapy treatment, anti-PSMAxCD28 (REGN5678), that enables T cells to directly bind with and kill prostate cancer cells.) 2023 PCF Challenge Award Project Title: Modulation of Anti-Androgen Response by NSD2 in Castration-Resistant Prostate Cancer Principal Investigators: Michael Shen, PhD, Andrea Califano, PhD, of Columbia University Medical Center; Johann de Bono, MD, PhD, The Institute of Cancer Research; Charles L. Sawyers, MD, Memorial Sloane Kettering Cancer Center (Elucidating the mechanisms of NSD2 action, a critical driver and promising therapeutic target against highly aggressive neuroendocrine prostate cancer, to provide a foundation for early-phase trials of NSD2 inhibitors.) 2023 Bayer-PCF Darolutamide Challenge Award Project Title: Darostep: Evaluating Step Counts as a Biomarker and its Relationship on Treatment Outcomes in Vulnerable Patients with Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy Principal Investigators: Russell Szmulewitz, MD, Nabiel Mir, MBBS, Megan Huisingh-Scheetz, all of The University of Chicago (Evaluating the impact of treatment with darolutamide on age-related outcomes in vulnerable, older patients with metastatic hormone-sensitive prostate cancer.) 2023 Movember, Todd Boehly, Shmuel Meitar, Richard Merkin, MD, Marcel Claure-PCF Challenge Award Project Title: Identification of Patients at High-Risk of Metastatic Disease After Neoadjuvant Intensive Androgen Signaling Inhibition Principal Investigators: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute; Steven Balk, MD, PhD, Beth Israel Deaconess Medical Center (Developing biomarkers for identifying patients with high-risk localized prostate cancer who are likely to benefit from neoadjuvant androgen receptor signaling inhibitors (ARSI) which could lead to a new treatment paradigm that will cure more patients at the localized disease stage.) 2023 Igor Tulchinsky-PCF Challenge Award Project Title: ctDNA Determinants of Resistance to 177Lu-PSMA-617 versus Taxane-Based Chemotherapy Principal Investigators: Alexander Wyatt, PhD, Vancouver Prostate Centre; Arun Azad, MD, Michael Hofman, Peter MacCallum Cancer Centre; Kim Chi, MD, BC Cancer (Developing new blood-based biomarker tests to predict how well patients with metastatic castration-resistant prostate cancer will respond to 177Lu-PSMA-617 versus taxane chemotherapy while identifying new molecular mechanisms that drive treatment resistance.) 2023 Richard Solomon, Igor Tulchinsky, Darius Bikoff, John Paulson, Richard Sandler, Bill Mack, Jason Safriet-PCF Challenge Award Project Title: New Targeted Epigenetic Therapy for Androgen Receptor-Negative Prostate Cancer Principal Investigators: Ming-Ming Zhou, PhD, Icahn School of Medicine at Mount Sinai; Kunhong Xiao, PhD, Allegheny Health Network Cancer Institute (Establishing the mechanisms of action and preclinical efficacy of a novel BRD4- targeted therapy for diverse subtypes of metastatic castration-resistant prostate cancer.) About the Prostate Cancer Foundation The Prostate Cancer Foundation (PCF) is the world's leading philanthropic organization dedicated to funding life-saving prostate cancer research. Founded in 1993 by Mike Milken, PCF has been responsible for raising more than $1 billion in support of cutting-edge research through more than 2,250 research projects at 245 leading cancer centers, with a global footprint spanning 28 countries. Since PCF's inception, and through its efforts, patients around the world are living longer, suffering fewer complications, and enjoying better quality of all life. PCF is committed to creating a global public square for prostate cancer, in service to our mission of ending death and suffering from the disease. Learn more at pcf.org. MEDIA CONTACT: Staci L. Vernick Prostate Cancer Foundation [email protected] [email protected] 610-812-6092 SOURCE Prostate Cancer Foundation

SAN FRANCISCO--( BUSINESS WIRE )-- ArteraAI , the developer of multimodal artificial intelligence (MMAI) based predictive and prognostic cancer tests, today announced its continued work with Movember , the leading charity changing the face of men's health on a global scale. “We are privileged to stand shoulder to shoulder with industry leaders in the battle against prostate cancer,” said Andre Esteva, CEO and co-founder of ArteraAI. “It is through strategic collaborations with those who share a passion for advancing how we treat this disease, that we will be able to harness AI to accelerate personalized cancer treatment.” This announcement follows a recent study presented at the 2023 European Society for Medical Oncology Congress (ESMO). The study successfully validated ArteraAI's prognostic model in advanced prostate cancer, demonstrating stronger prognostic correlations than individual clinical factors. This study was a component of the broader STRATOSPHere project, initiated and funded by Movember and Prostate Cancer UK, an initiative to accelerate the progress of precision medicine by using data from tumor and blood samples of men participating in STAMPEDE , to identify biomarker-treatment pairings to personalize therapy. ArteraAI looks forward to its continued work with these organizations as there are several ongoing initiatives in the early development phase. "Being able to predict what might happen for men with aggressive prostate cancer is incredibly important,” said Sarah Hsiao, Director, Biomedical Research and Impact. “Movember is proud to have supported the STRATOSPHere team on this innovative research, leveraging ArteraAI’s technology to empower men with prostate cancer and their providers to make informed treatment decisions." Although prostate cancer is a common disease , it currently lags behind other cancers in terms of precision medicine advancements. This gap means that many men do not always receive the most suitable treatments, potentially leading to life-altering side effects or even fatal outcomes. While current guidelines provide general recommendations on how to treat prostate cancer, they are not personalized to the individual. Cancer is personal. Cancer therapy should be too. For more information on ArteraAI, visit Artera.ai . About ArteraAI ArteraAI is a leading precision medicine company developing AI tests to personalize cancer therapy. ArteraAI offers an AI-enabled test that is the first of its kind to provide both predictive and prognostic results for patients with localized prostate cancer: ArteraAI Prostate Test. ArteraAI’s multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient’s biopsy and learns from a patient's clinical data. The AI combines this information to predict whether a patient will benefit from a particular therapy and determine their prognosis. ArteraAI Prostate Test is the first test that can both predict therapy benefit and prognosticate long-term outcomes in localized prostate cancer. The test is clinically available through our CLIA-certified laboratory in Jacksonville, Florida and can be ordered online at Artera.ai . About Movember Movember is the leading charity changing the face of men's health on a global scale, focusing on mental health and suicide prevention, prostate cancer and testicular cancer. The charity raises funds to deliver innovative, breakthrough research and support programs that enable men to live happier, healthier and longer lives. Committed to disrupting the status quo, millions have joined the movement, helping fund over 1,250 projects around the world. In addition to tackling key health issues faced by men, Movember is working to encourage men to stay healthy in all areas of their lives, with a focus on men staying socially connected and becoming more open to discussing their health and significant moments in their lives. The charity's vision is to have an everlasting impact on the face of men's health. To donate or learn more, please visit Movember.com.

Highlights Clarity recently reported that in its diagnostic Phase 1/2 trial, COBRA, 64Cu-SAR-bisPSMA was found to be safe and highly effective in detecting prostate cancer (PC) lesions in patients with biochemical recurrence (BCR). In trial participants where standard of care (SOC) imaging was unable to detect any lesions, up to approximately 60% had lesions identified by same-day imaging with 64Cu-SAR-bisPSMA and up to 80% on next-day imaging, with high specificity on both days. The number of lesions identified by 64Cu-SAR-bisPSMA almost doubled from same-day (up to 80) to next-day imaging (up to 153). One of the reasons for the higher detection of lesions on next-day imaging was due to the ability of 64Cu-SAR-bisPSMA to detect much smaller lesions compared to other prostate specific membrane antigen (PSMA) agents, including a lesion with a diameter of less than 2 mm. For all lesions, regardless of their size, 64Cu-SAR-bisPSMA lesion uptake increased by more than 80% and lesion contrast increased almost 5 times when comparing same-day to next-day imaging. A key observation was the high uptake and contrast observed in lesions of less than 5 mm. More lesions and smaller lesions detected on next-day imaging could have a substantial impact on how patients are treated. The detection of lesions that are less than 5 mm in size by current PSMA positron emission tomography (PET) imaging agents (including PYLARIFY® and the generic product 68Ga-PSMA-11) is challenging, which possibly contributes to the low sensitivity of these agents. The information gathered from the Phase 1/2 COBRA trial, including the size of lesions that are detected by 64Cu-SAR-bisPSMA, will be used to inform the design of the registrational Phase 3 trial in patients with BCR of PC. SYDNEY, March 8, 2024 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to share additional data from its diagnostic 64Cu-SAR-bisPSMA trial, COBRA (NCT05249127)[1]. COBRA was a multi-centre, single-arm, non-randomised, Phase 1/2 diagnostic imaging study of 64Cu-SAR-bisPSMA administered to participants with BCR of PC following definitive therapy and who had a negative or equivocal SOC scan at screening. The primary objectives of the trial were to investigate the safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of PC. Patients underwent PET/computed tomography (CT) scans with 64Cu-SAR-bisPSMA on Day 0 and Day 1 (1-4h and 24±6h post-dose, respectively), which were interpreted by three blinded central readers. Following the recent announcement of positive results from the COBRA trial[2], which began showcasing the many benefits of 64Cu-SAR-bisPSMA, further analysis of the data reveals additional advantages of this optimised PSMA product. 64Cu-SAR-bisPSMA was able to detect much smaller lesions than anticipated, including a lesion with a diameter of less than 2 mm. This compares favourably against the current SOC PSMA PET imaging agents, including PYLARIFY® and the generic product 68Ga-PSMA-11, with which the detection of lesions smaller than 5 mm is challenging. Sensitivity is a known challenge for the existing PSMA PET agents, particularly for lesions <5 mm[3]-[6]. This suggests that lesions are missed by current SOC imaging, which can have significant implications on accurate staging and subsequent treatment decisions. For those undergoing initial staging of their disease, missing lesions may lead to unnecessary surgery resulting in long-lasting side effects (e.g. impotence and/or incontinence following the removal of the prostate)[7]. In patients with BCR of PC, it is also crucial to identify their cancer early to avoid disease progression and the side effects of systemic treatments that accompany such therapies[8]. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "The cornerstone of better therapy is better diagnosis, and we are incredibly excited about the substantial degree of improvement in detection of lesions with our bisPSMA product compared to SOC imaging. This difference is similar to comparing the old Hubble telescope to the new James Webb telescope, allowing us to visualise with much greater clarity, and to effectively change the paradigm of treatment to considerably improve the outcomes for patients with PC. Innovative products like 64Cu-SAR-bisPSMA may prevent many millions of men from receiving inappropriate treatments and suffering substantial debilitating side effects from surgery or other therapies. "When combining the optimised dual PSMA targeting agent with the ideal half-life of copper-64 (64Cu), we continue to observe higher uptake and retention of 64Cu-SAR-bisPSMA in PC lesions. We believe the ability of 64Cu-SAR-bisPSMA to detect such small lesions is due to the higher uptake and retention of the product over time with high contrast (parameters measured by mean standardised uptake value [SUVmean], maximum standardised uptake value [SUVmax] and tumour-to-background ratio [TBR]). Small lesions become more readily detectable if the uptake of the product in the lesion is high and the background noise on the image is low. This effect enhances the contrast, making the lesion easier to detect, providing clinicians with valuable information on how to best treat their patients." The size of the PC lesions detected by 64Cu-SAR-bisPSMA was recorded on the same-day (Day 0) and next-day (Day 1) imaging. Lesions with less than 5 mm in size were identified across readers among 14% (7/50) of patients (Figures 1 and 2). These lesions were located in the bone, pelvic and extra-pelvic lymph node regions. The smallest lesion (pelvic lymph node) identified in the study was 2.6 x 1.9 mm (Figure 3). The SUVmax, SUVmean and TBR were assessed in up to 25 lesions per patient on the same-day and next-day 64Cu-SAR-bisPSMA PET imaging. Mean SUVmean and SUVmax increased more than 80% (82% and 87% average increase across all readers, respectively) and TBR increased almost 5 times (4.8x average increase across all readers) comparing same-day with next-day imaging (ranges among readers, Day 0 and Day 1, respectively: SUVmean 6.6-9.9 and 14.7-15.8; SUVmax 13.9-14.0 and 22.2-33.4; TBR 23.2-25.4 and 118.1-181.7) (Graphs 1 and 2). Lesions of less than 5 mm in size had SUVmean, SUVmax and TBR value of 16.3, 16.8 and 90.1, respectively (mean values across all readers). The ability of 64Cu-SAR-bisPSMA to detect lesions less than 5 mm is a result of a few factors unique to the product. 64Cu has a longer half-life (12.7 h) than the isotopes used in currently approved PSMA PET agents, such as gallium-68 (68Ga) and fluorine-18 (18F) (<2 h), enabling next-day imaging, which is impossible with 18F- and 68Ga-based agents. Clarity's SAR Technology holds isotopes of copper securely inside a cage, preventing their leakage when administered to patients. Pre-clinical and clinical evidence has demonstrated that the optimised dual targeting molecule connected to the cage, bisPSMA, ensures increased targeting and retention of the product in PC tumours compared to its single targeting molecule counterpart and approved PSMA agents[9],[10]. Results from Clarity's Phase I PROPELLER trial substantiated this hypothesis as 64Cu-SAR-bisPSMA showed detection of additional lesions and 2-3 times greater uptake within the same PC lesions compared to the generic SOC imaging agent, 68Ga-PSMA-11. Furthermore, the initial positive results from the COBRA study, announced on the 15th of February 2024[2], showed that delayed imaging with 64Cu-SAR-bisPSMA is able to detect PC lesions in up to 80% of patients with BCR of PC, who demonstrated negative or equivocal SOC imaging at screening. It also showed that the number of lesions detected by 64Cu-SAR-bisPSMA almost doubled on delayed imaging compared to same-day imaging. "The COBRA trial was designed to showcase the true benefits of bisPSMA compared to current SOC imaging, implementing a high standard of study design to validate our findings and utilise an unbiased view of assessment. The results are nothing short of extraordinary, and as we continue to adhere to best practice in clinical development, our science at Clarity is clearly differentiating us from our competitors. Combined with our clinical and pre-clinical evidence to date, this data further validates SAR-bisPSMA as a potential best-in-class PSMA agent for the diagnosis (with 64Cu) and subsequent treatment (with copper-67 [67Cu]) of PC. The benefits of 64Cu-SAR-bisPSMA are now even more evident, given the highest scientific rigour applied to the COBRA study design, and confirmed by clinicians who reported that they would change their treatment plan in response to the 64Cu-SAR-bisPSMA scan results in approximately half of their trial patients. Our COBRA trial was an exploratory first-in-human Phase 1/2 trial in BCR to generate information to allow us to meticulously design a Phase 3 registrational trial. Now that we know what we are looking for, including lesions in the 2 mm range, we can structure a Phase 3 trial in the BCR of PC indication to clearly differentiate ourselves from the first-generation PSMA agents as we head towards our ultimate goal of improving treatment outcomes for people with cancer," Dr Taylor said. About SAR-bisPSMA SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) Technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR Technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy. 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA are unregistered products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA). A clinical development program is currently underway to assess the efficacy and safety of these products. There is no guarantee that these products will become commercially available. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide[11]. The American Cancer Institute estimates in 2024 there will be 299,310 new cases of prostate cancer in the US and around 35,250 deaths from the disease[12]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults. References Clinicaltrials.gov Identifier: NCT05249127. clinicaltrials.gov/ct2/show/NCT05249127 Initial COBRA results announcement. 15 Feb 2024. claritypharmaceuticals.com/news/cobra_results/ Pienta et al. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY). Journal of Urology, 2021. Hope et al. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection. JAMA Oncol, 2021. Petersen et al. 68Ga-PSMA PET/CT compared with MRI/CT and diffusion-weighted MRI for primary lymph node staging prior to definitive radiotherapy in prostate cancer: a prospective diagnostic test accuracy study. World Journal of Urology, 2019. Surasi et al. Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). European Urology, 2023. Stanford et al. Urinary and Sexual Function After Radical Prostatectomy for Clinically Localized Prostate Cancer. The Prostate Cancer Outcomes Study. JAMA, 2000. Shore et al. Biochemical recurrence in patients with prostate cancer after primary definitive therapy: treatment based on risk stratification. Prostate Cancer and Prostatic Diseases, 2023. Zia et al. A Bivalent Inhibitor of Prostate Specific Membrane Antigen Radiolabeled with Copper-64 with High Tumor Uptake and Retention. Angew Chem Int Ed Engl. 2019. Lengyelova et al. 64Cu-SAR-bisPSMA (PROPELLER) positron emission tomography (PET) imaging in patients with confirmed prostate cancer. ASCO, 2023. Global Cancer Statistics 2020. GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660 American Cancer Society Key Statistics for Prostate Cancer. cancer.org/cancer/prostate-cancer/about/key-statistics.html This announcement has been authorised for release by the Executive Chairperson. View original content to download multimedia: SOURCE Clarity Pharmaceuticals Company Codes: Australia:CU6