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FDA authorizes trial of novel PSMA-PET imaging diagnostic in prostate cancer


The FDA has authorized the launch of the phase 1/2 COBRA trial exploring the novel PSMA-PET imaging agent 64Cu-SAR-bisPSMA in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy.1

According to Clarity Pharmaceuticals, the company developing 64Cu-SAR-bisPSMA, COBRA is a multicenter, open-label, single-arm study with a targeted enrollment of up to 50 patients. The study’s primary end points are the capacity of 64Cu-SAR-bisPSMA to detect prostate cancer recurrence, as well as the safety and tolerability of the imaging agent.

Neal Shore, MD

Neal Shore, MD

"I am impressed by the images seen to date and look forward to working together with Clarity on the COBRA trial, exploring the clinical benefits of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer. Higher uptake of the product in tumors may offer improvements in diagnosis of disease, which is particularly relevant for patients with suspected recurrence of prostate cancer. The ability to diagnose the disease earlier offers the potential to provide better treatment options earlier. When these benefits are combined with the ability to supply the products on demand and in large scale, this may be a game changer for prostate cancer management,” Neal Shore, MD, principal investigator of the COBRA trial, as well as CMO – Urology/Surgical Oncology, GenesisCare, US, and medical director of Carolina Urologic Research Center, stated in a news release.

Other ongoing trials are also exploring 64Cu-SAR-bisPSMA. The phase 1 PROPELLER trial (NCT04839367) is examining 64Cu-SAR-bisPSMA in patients with treatment-naïve, histologically confirmed prostate cancer who are scheduled for radical prostatectomy. In the phase 1/2a SECURE trial (NCT04868604) 64Cu-SAR-bisPSMA is being explored along with the investigational PSMA targeted therapy 67Cu-SAR-bisPSMA in patients with metastatic castration-resistant prostate cancer.

In the news release, Dr. Alan Taylor, executive chairman of Clarity, commented, "The preliminary data from our SAR-bisPSMA trials in Australia and the United States look very promising and the high uptake and retention of SAR-bisPSMA shown in preclinical and clinical trials to date may lead to improved detection in patients with prostate cancer, particularly those with low PSA levels. Our team and our collaborators are excited to commence the COBRA trial, generating more data to progress the development of SAR-bisPSMA as we move this product closer to registration in the United States.

"We also look forward to further validating our on-demand distribution model as the trial sites will be supplied with ready-to-use cGMP 64Cu-SAR-bisPSMA product. Clarity's vision is to move the diagnostic field towards centrally manufactured products that can be delivered on demand, shifting away from the supply constraints of the first generation of PET agents such as gallium-68 and fluorine-18 and the burdensome challenges of short-lived radionuclides. But most importantly, on-demand central manufacture of radiopharmaceuticals could potentially improve patient care by focusing on the needs of patients and their treating staff, delivering critical treatments that are safe and efficacious, on time and at any treatment center with a PET camera."


1. US FDA Study May Proceed letter for Clarity's Cu-64 SAR-bisPSMA trial in prostate cancer. Published online February 7, 2021. Accessed February 8, 2022. https://prn.to/3JfKr1o

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