Clarity Pharmaceuticals said on October 27, 2026, that its Phase III CLARIFY trial had dosed its planned target of 383 participants. The study is evaluating an experimental imaging agent for detecting prostate cancer in pelvic lymph nodes before surgery.

Key Takeaways

  • The study is Clarity’s first Phase III registrational trial and is being conducted in the United States and Australia.
  • Clarity expects topline results in the first half of 2027; the imaging agent is not yet approved.

What the CLARIFY trial will measure

CLARIFY is testing 64Cu-SAR-bisPSMA, an agent used with positron emission tomography, or PET, imaging. Its participants have untreated, confirmed prostate cancer with high-risk features and are proceeding to prostate removal and pelvic lymph node dissection.

The study will measure how accurately the agent detects cancer in pelvic lymph nodes, using examination of surgically removed tissue as the reference. It will assess scans taken one to four hours after administration and approximately 24 hours afterward separately.

The trial is non-randomized and open-label, with blinded review of the images. Reaching the dosing target does not mean the results are available: Clarity said patient follow-up is continuing.

Results and regulatory plans

Clarity expects topline CLARIFY data in the first half of calendar 2027, alongside topline results from its AMPLIFY trial of the same imaging agent in patients whose prostate cancer has recurred.

The company intends the final CLARIFY results to support an application to the US Food and Drug Administration for approval of the agent in patients before definitive treatment. The product is unregistered, and its safety and efficacy have not been assessed by the FDA or Australia’s Therapeutic Goods Administration. Clarity said there is no guarantee it will become commercially available.

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