On December 24, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the acceptance of an abstract on the Co-PSMA (NCT06907641)1 Investigator-Initiated Trial (IIT), led by Prof Louise Emmett at St Vincent’s Hospital Sydney, for oral presentation at the upcoming European Association of Urology (EAU) Congress 2026, Europe’s biggest urological conference, to be held 13-16 March 2026 in London, UK2.
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Co-PSMA’s official study title is "Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy". This Phase II IIT evaluated the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to standard-of-care (SOC) 68Ga-PSMA-11 in 50 patients with low prostate-specific antigen (PSA) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL.
The results to be presented by Prof Emmett at the EAU Congress 2026 will expand on the earlier findings that the trial met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA positron emission tomography (PET) / computed tomography (CT) detected significantly more lesions per patient than the SOC, 68Ga-PSMA-11 PET/CT3. These results further build on the growing body of evidence showing that 64Cu-SAR-bisPSMA improves the detection of prostate cancer, compared to the current SOC prostate-specific membrane antigen (PSMA) PET agents which are known to have low sensitivity, especially in patients with low PSA levels4,5.
Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "64Cu-SAR-bisPSMA has been purposely developed at the benchtop to overcome the many shortfalls of the current SOC PSMA imaging agents. With the molecule only being invented some 7 years ago, we have already demonstrated at the cellular level, in animal models and now in multiple clinical trials, that 64Cu-SAR-bisPSMA is clearly differentiated from the competitors. In a very short amount of time, we have moved from invention to two registrational Phase III trials, both to complete recruitment next year, continuing to build on strong evidence generated to date of the improved diagnostic performance of our product through various clinical trials and real-world evidence (compassionate use supply). We reported earlier that our optimised agent detects more lesions in this IIT head-to-head comparison against the SOC product3. We also know that 64Cu-SAR-bisPSMA identifies more as well as smaller lesions and was able to do so earlier than SOC PSMA PET agents in our Phase II COBRA trial6. The full results from Co-PSMA will again reinforce the mounting data showing how 64Cu-SAR-bisPSMA can outperform SOC PSMA PET products.
"We are committed to a rigorous scientific and clinical development process, which has delivered exceptional results to date. The acceptance of the Co-PSMA data by this world-leading urology conference for an oral presentation is a testament to its strength and quality. This recognition not only highlights the impact of this research but also underscores the significant potential of 64Cu-SAR-bisPSMA to advance PSMA imaging and improve prostate cancer management. The abstract summary will be announced in mid-February, followed by the oral presentation in mid-March 2026.
"Prof Emmett is a global key opinion leader in the field of urologic nuclear medicine, with a strong track record of highly regarded scientific publications as well as extensive clinical experience. We are honoured to continue working together on our registrational AMPLIFY7 and CLARIFY8 trials and trust that her unique expertise and commitment to providing the best available patient care will help us to get closer to our mutual goal of improving detection and treatment paradigm for prostate cancer patients.
"With two US Food and Drug Administration (FDA) Fast Track Designations for 64Cu-SAR-bisPSMA and two ongoing registrational trials, we are extremely excited to enter the USD 2 billion PSMA PET imaging market as it is further expected to grow to over USD 3 billion by 2029 with not only a clearly differentiated agent, but also a product with substantial logistical benefits over the current competitors."
(Press release, Clarity Pharmaceuticals, DEC 24, 2025, View Source [SID1234661608])