Highlights

  • Target of 383 participants dosed in the registrational Phase III CLARIFY trial.
  • Trial assesses 64Cu-SAR-bisPSMA PET imaging before radical prostatectomy.
  • Topline results expected in the first half of calendar 2027.
  • Two registrational Phase III trials have now completed recruitment.

Clarity Pharmaceuticals Limited (ASX:CU6) has dosed its planned target of 383 participants in the registrational Phase III CLARIFY trial. The study is assessing the diagnostic performance of 64Cu-SAR-bisPSMA PET imaging in people with high-risk prostate cancer who are scheduled for radical prostatectomy.

Trial Design

CLARIFY is a single-arm, multi-centre study running in the United States and Australia. Its primary endpoints are the sensitivity and specificity of 64Cu-SAR-bisPSMA for detecting prostate cancer in pelvic lymph nodes, compared with histopathology.

The trial is testing both same-day imaging and next-day imaging about 24 hours after administration. Clarity said next-day imaging improved diagnostic performance in its earlier COBRA and Co-PSMA trials.

Supporting Data

In the Phase I PROPELLER study of 30 participants, the company reported that same-day 64Cu-SAR-bisPSMA imaging showed about 30% greater lesion detection and two to three times higher tracer uptake compared with 68Ga-PSMA-11.

Clarity noted that currently approved PSMA PET agents reported sensitivities of 27% to 40% for pelvic lymph node detection in their pivotal trials, which it says supports the case for next-generation products.

Next Steps

Topline results from CLARIFY and the AMPLIFY trial are expected in the first half of calendar 2027. CLARIFY is intended to support a US FDA application for 64Cu-SAR-bisPSMA as a diagnostic imaging agent.

Executive Chairperson Dr Alan Taylor said the milestone was a significant achievement. The company noted its products are unregistered and have not been assessed for safety or efficacy by the FDA or TGA.

Key Takeaways

  • CLARIFY has reached its enrolment target of 383 participants.
  • The trial is designed to support a future FDA application.
  • Topline results are expected in H1 2027.
  • The products remain investigational and unregistered.