PET Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (CLARIFY)

 The 2025 GU ASCO annual meeting featured a prostate cancer trials in progress session and a presentation by Michael Gorin discussing CLARIFY, a phase 3 diagnostic performance study assessing PET using ⁶⁴Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy. Prostate cancer is the second most prevalent cancer in men globally. In men with newly diagnosed, high-risk disease, prostate cancer most often spreads to the pelvic lymph nodes before becoming widely metastatic. Read More

• 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.

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The 2024 ASCO annual meeting was host to a presentation by Dr. Michael Gorin, who presented CLARIFY, a phase III diagnostic study of positron emission tomography (PET) using ⁶⁴Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy. Read More

• 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.

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• 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.

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Reno, Nevada (UroToday.com) Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the 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 it has entered into a Clinical Manufacturing Agreement with SpectronRx for the production of the diagnostic 64Cu-SAR-bisPSMA product for its Phase III trials. This agreement builds on the earlier Master Services Agreement and Supply Agreement for the production of the 64Cu isotope, now allowing for a streamlined manufacturing process of both the isotope and the 64Cu-SAR-bisPSMA product at the same facility. Read More

Reno, Nevada (UroToday.com) -- Clarity Pharmaceuticals (ASX: CU6) (“Clarity”, “the 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions with suspected metastasis who are candidates for initial definitive therapy. Read More

• First patient safely dosed in the pivotal Phase III 64Cu-SAR-bisPSMA diagnostic trial, CLARIFY.
• The aim of the CLARIFY trial is to detect regional nodal metastases in participants with prostate cancer prior to radical prostatectomy.
• Final results from the CLARIFY trial are intended to provide sufficient evidence to support an application to the FDA for the approval of the 64Cu-SAR-bisPSMA product in pre-prostatectomy patients.

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