Co-PSMA abstract accepted for oral presentation at EAU Annual Congress 2026
SYDNEY, Dec. 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, announces that an abstract on the Co-PSMA (NCT06907641) Investigator-Initiated Trial (IIT), led by Prof Louise Emmett at St Vincent’s Hospital Sydney, has been accepted for oral presentation at the European Association of Urology (EAU) Congress 2026, to be held 13-16 March 2026 in London, UK.
The Co-PSMA study is titled ‘Comparative performance of 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 Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison with 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 had previously undergone radical prostatectomy with no salvage therapy and had PSA levels between 0.2 and 0.75 ng/mL.
The results to be presented by Prof Emmett at the EAU Congress 2026 expand on earlier findings that the trial met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA PET/CT detected significantly more lesions per patient than SOC 68Ga-PSMA-11 PET/CT. These data add to growing evidence that 64Cu-SAR-bisPSMA improves prostate cancer detection relative to current SOC PSMA PET agents, which are known to have limited sensitivity in patients with low PSA.
Dr Alan Taylor, Executive Chairperson of Clarity, said: ‘64Cu-SAR-bisPSMA has been developed to address the limitations of current PSMA imaging agents. Since its invention approximately seven years ago, we have shown differentiated performance at the cellular level, in animal models and now across multiple clinical trials. We have progressed rapidly from invention to two registrational Phase III trials, both expected to complete recruitment next year, building on strong evidence of improved diagnostic performance from trials and real-world use. In the Co-PSMA IIT head-to-head comparison, our optimised agent detected more lesions than the SOC product. We also observed detection of more and smaller lesions and earlier detection than SOC agents in our Phase II COBRA trial. The full Co-PSMA results will further reinforce the mounting data that 64Cu-SAR-bisPSMA can outperform SOC PSMA PET products.’
‘We are committed to a rigorous scientific and clinical development process,’ Dr Taylor continued. ‘Acceptance of Co-PSMA data for an oral presentation at this leading urology conference recognises the strength and quality of the research and highlights the potential of 64Cu-SAR-bisPSMA to advance PSMA imaging and improve prostate cancer management. The abstract summary will be announced in mid-February, ahead of the oral presentation in mid-March 2026.’
‘Prof Emmett is a global key opinion leader in urologic nuclear medicine, with an outstanding track record of scientific publications and clinical experience. We are honoured to continue collaborating with her on our registrational AMPLIFY and CLARIFY trials and believe her expertise will help advance detection and treatment paradigms 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 excited about entering the estimated USD 2 billion PSMA PET imaging market with a clearly differentiated agent that also offers substantial logistical benefits over current competitors.’
About SAR-bisPSMA
SAR-bisPSMA combines two PSMA-targeting moieties with Clarity’s proprietary sarcophagine (SAR) chelator technology, which securely holds copper isotopes in a cage-like structure and prevents copper leakage. SAR-bisPSMA is a Targeted Copper Theranostic usable with copper-64 (64Cu) for imaging and copper-67 (67Cu) for therapy.
Disclaimer
64Cu-SAR-bisPSMA is an unregistered product. Its safety and efficacy have not been assessed by regulatory authorities such as the US FDA or the Australian Therapeutic Goods Administration (TGA). There is no guarantee this product will become commercially available.
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men worldwide and a leading cause of cancer death in men. The American Cancer Society estimated that in 2025 there would be about 313,780 new prostate cancer cases in the US and approximately 35,770 deaths from the disease.
About Clarity Pharmaceuticals
Clarity is a clinical-stage radiopharmaceutical company focused on developing Targeted Copper Theranostics based on its SAR Technology Platform to treat cancers.
www.claritypharmaceuticals.com
For more information, please contact
- Dr Alan Taylor — Executive Chairperson, Clarity Pharmaceuticals
- Lisa Sadetskaya — Director, Corporate Communications, Clarity Pharmaceuticals
References
- ClinicalTrials.gov Identifier: NCT06907641 — https://clinicaltrials.gov/study/NCT06907641
- EAU26 The Congress — https://eaucongress-new.uroweb.org/the-congress
- Clarity Pharmaceuticals. Co-PSMA trial achieves primary endpoint — https://www.claritypharmaceuticals.com/news/co-psma-endpoint/
- Fendler WP et al., JAMA Oncology 2019; Assessment of 68Ga-PSMA-11 PET accuracy in localizing recurrent prostate cancer.
- Mena E et al., Journal of Nuclear Medicine 2020; 18F-DCFPyL PET/CT imaging in biochemically recurrent prostate cancer.
- Nordquist et al., COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA, EANM 2024.
- AMPLIFY clinical trial — ClinicalTrials.gov Identifier: NCT06970847
- CLARIFY clinical trial — ClinicalTrials.gov Identifier: NCT06056830
- Global Cancer Statistics 2020: GLOBOCAN — https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660
- American Cancer Society: Key Statistics for Prostate Cancer — https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
This announcement has been authorised for release by the Executive Chairperson.
SOURCE: Clarity Pharmaceuticals