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64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
Videos

64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 1/2 Study of Participants With Biochemical Recurrence of Prostate Cancer

  • Condition: Biochemical Recurrence of Malignant Neoplasm of Prostate
  • Study ID: NCT05249127
ACTIVE, NOT RECRUITING
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Luke Nordquist, MD
(UroToday.com) The 2024 Society of Nuclear Medicine & Molecular Imaging (SNMMI) annual meeting featured a session on prostate cancer, and a presentation by Dr. Luke Nordquist discussing results of COBRA, an assessment of the safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy.
Presented by Luke Nordquist, MD, FACP
The 2024 ASCO annual meeting featured a session on prostate cancer, and a presentation by Dr. Luke Nordquist discussing results of COBRA, an assessment of the safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy.
Press Release
Official Announcements on Clinical Developments
  • Nucleus RadioPharma will manufacture the 67Cu-SAR-bisPSMA drug product at their new state-of-the-art facility in Rochester, MN.
  • The Master Services Agreement (MSA) and Clinical Supply Agreement with Nucleus RadioPharma complement the existing agreement with NorthStar Medical Radioisotopes, LLC (NorthStar) for 67Cu-SAR-bisPSMA production to expand drug manufacturing in anticipation of recruitment demand for Phase II and III trials of this product.

  • United States Food and Drug Administration (U.S. FDA) provided positive feedback on a pivotal Phase III trial for 64Cu-SAR-bisPSMA diagnostic in prostate cancer patients with biochemical recurrence (BCR), AMPLIFY.
  • The positive results of the completed COBRA and PROPELLER trials, including the significantly higher uptake and retention in lesions compared to standard-of-care (SOC) imaging, as well as the substantial increase in the number of lesions detected with next-day imaging compared to same-day imaging, formed the data package to guide the design of the AMPLIFY trial.


  • Two abstracts outlining Clarity’s latest SAR-bisPSMA data have been accepted to be presented at the upcoming European Association of Nuclear Medicine (EANM) 2024 Congress on the 19-23 October.
  • Abstracts on the diagnostic clinical trial, COBRA, and a theranostic case report (complete response in a patient with metastatic castrate-resistant prostate cancer [mCRPC]) were accepted for oral presentation.
  • The COBRA abstract was selected as a Top-Rated Oral Presentation within the Scientific Programme (Oncology & Theranostic) of the EANM 2024 Congress.

  • 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).
  • Initial data from Clarity’s diagnostic Phase 1/2 trial, COBRA, confirms 64Cu-SAR-bisPSMA is safe and highly effective in detecting prostate cancer (PC) lesions in patients with biochemical recurrence (BCR).
  • Confirmed unique benefit of 64Cu-SAR-bisPSMA for next-day imaging in this patient population, with more lesions and more patients with a positive scan identified via the next-day scan.