2. UroToday Home
  3. Transformative Evidence

Transformative Evidence

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
  • Two abstracts on Clarity’s diagnostic COBRA and CLARIFY trials with 64Cu-SAR-bisPSMA have been accepted for presentation at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025.
  • An abstract on the COBRA study has also been selected for presentation at the American Urological Association (AUA) Annual Meeting 2025.
  • The data to be presented shows that 64Cu-SAR-bisPSMA identifies more lesions and at earlier timepoints than currently approved prostate-specific membrane antigen (PSMA) positron emission tomography (PET) agents, and with a high true positivity rate based on histopathology assessment. Lesions <5 mm in size were identified by 64Cu-SAR-bisPSMA in 14% of participants (including lesions in the 2 mm range).
  • The early identification and detection of lesions can inform treatment selection and impact the outcomes for prostate cancer patients.

Reno, Nevada (UroToday.com) -- 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 children and adults with cancer, is pleased to announce the acceptance of two abstracts for presentation at the ASCO GU 2025 Conference on Clarity’s COBRA and CLARIFY trials and an abstract on the COBRA trial at the AUA Annual Meeting 2025. These conferences are among the world’s most prestigious in oncology and urology, and the acceptance of these abstracts is testament to the strength of Clarity’s data and the exciting prospects for the diagnostic 64Cu-SAR-bisPSMA to change the paradigm in the diagnosis and treatment of cancer.
Reno, Nevada (UroToday.com) -- 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 announce that two participants have been dosed and imaged days after the commencement of the Co-PSMA Investigator-Initiated Trial (IIT). The study is evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in comparison to standard-of-care (SOC) 68Ga-PSMA-11 for the detection of prostate cancer recurrence. No safety issues were observed during the administration of 64Cu-SAR-bisPSMA.
  • 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.