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

Trials in Progress
Videos

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

  • Condition:Prostate Cancer, Prostatic Neoplasms
  • Study ID: NCT06056830
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Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Michael A. Gorin, MD
 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.
Presented by Press Release
  • 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.
Presented by  Michael Gorin, MD
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.
Press Releases
Official Announcements on Clinical Developments
  • Clarity has successfully completed a $203 million Placement with a small group of institutional investors who are close to the Company.
  • The issue price of the Placement is $4.20 per share, which represents a 2.2% premium to Clarity’s previous closing price and an 18.0% premium to Clarity’s 15-day Volume Weighted Average Price (“VWAP”).
  • Following completion of the Placement, the pro-forma cash balance of the Company is approximately $288 million,1 providing Clarity with an enviable Balance Sheet. This will help fund the below-mentioned expected catalysts and milestones, including the completion of a number of high-value pivotal clinical trials and advancement of key milestones in its therapeutic and diagnostic pipeline.

  • 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.
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.
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.