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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Press Releases
Official Announcements on Clinical Developments
  • 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.
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 commenced its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)1, with the initiation of the first clinical site at the Urology Cancer Center / XCancer Omaha, NE.
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, and PSI CRO AG (“PSI”), a global contract research organisation committed to on-time enrollment in radiopharmaceutical clinical trials, have entered into an agreement and have commenced work towards Clarity’s Phase III diagnostic trial of SAR-bisPSMA in prostate cancer participants, CLARIFY (NCT06056830).1