Clarity Pharmaceuticals (ASX: CU6) has achieved a significant Clarity Pharmaceuticals AMPLIFY Trial Milestone, with its Phase III AMPLIFY trial exceeding planned participant numbers just nine months after imaging the first participant in May 2025. The company has now halted new patient consenting across all US and Australian sites pending final enrolment confirmation, marking a critical step toward regulatory submission for its next-generation prostate cancer diagnostic agent.
The rapid recruitment occurred despite three standard-of-care PSMA PET products already being commercialised by four different companies, signalling strong clinical demand for 64Cu-SAR-bisPSMA. Approximately 220 participants were targeted across multiple clinical sites in the registrational study.
Clarity Pharmaceuticals hits AMPLIFY recruitment target in 9 months
The Phase III AMPLIFY trial (NCT06970847) has consented in excess of its planned participant numbers following persistent demand from clinicians and patients at sites across the United States and Australia. Consenting of new patients has stopped at all sites pending completion of remaining screening assessments and confirmation of final enrolment numbers.
AMPLIFY is a non-randomised, single-arm, open-label, multi-centre diagnostic trial evaluating 64Cu-SAR-bisPSMA positron emission tomography (PET) in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment. The registrational study aims to investigate the diagnostic ability of 64Cu-SAR-bisPSMA PET/computed tomography (CT) to detect recurrence of prostate cancer in men with PSA levels above 0.2 ng/mL.
The trial commenced in May 2025, with the first participant imaged at XCancer with Dr Luke Nordquist in Omaha, NE. Reaching the target enrolment milestone in just 9 months represents accelerated progress for a pivotal trial, particularly given the competitive landscape of approved PSMA PET imaging products already in clinical use.
According to Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, the speed of enrolment highlights both the unmet need in the biochemical recurrence space and the strong demand for 64Cu-SAR-bisPSMA from clinicians seeking more effective prostate cancer detection diagnostics.
Dr Alan Taylor, Executive Chairperson
“We are about to enter the realm of a select few Australian companies who have developed a drug at the benchtop of Australian science and completed an international Phase III clinical trial with that drug, taking us one step closer to commercialisation.”
The company recruited participants at numerous different sites across the US and Australia to ensure the trial reflected the broad patient population, real-world clinical settings and various PET cameras in which the product is intended to be used. This strategy required careful planning to allocate participant numbers per site, resulting in what management believes will be a robust and well-balanced dataset supporting the integrity of the study.
The final study results from AMPLIFY are intended to provide evidence to support an application to the US Food and Drug Administration (FDA) for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in biochemical recurrence of prostate cancer.
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What is 64Cu-SAR-bisPSMA and why does it matter for prostate cancer detection?
64Cu-SAR-bisPSMA is a next-generation diagnostic imaging agent that uses copper-64 as a radioisotope for positron emission tomography (PET) scanning. The “bis” in its name reflects a novel design approach that connects two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology.
The SAR technology functions as a cage-like structure, called a chelator, that securely holds copper isotopes inside and prevents copper leakage into the body. This distinguishes it from other commercially available chelators and forms the foundation of Clarity’s Targeted Copper Theranostic (TCT) platform.
The agent offers clinical flexibility through same-day imaging (1-4 hours post-administration) and next-day imaging (approximately 24 hours post-administration), facilitated by copper-64’s half-life. This dual timepoint capability allows clinicians to optimise imaging protocols based on clinical workflow and patient needs.
The technology platform supports both diagnostic and therapeutic applications. 64Cu-SAR-bisPSMA uses copper-64 for imaging, while the same agent can be paired with copper-67 for therapy, creating a theranostic approach that enables the same targeting mechanism to both detect and treat disease.
The three key components of 64Cu-SAR-bisPSMA are:
- Radioisotope: Copper-64, which provides the radioactive signal for PET imaging
- SAR chelator: A cage-like structure that securely holds the radioisotope and prevents leakage into the body
- Two PSMA binding motifs: Targeting agents that bind to prostate-specific membrane antigen proteins expressed by cancer cells
Clinicians and patients have demonstrated preference for 64Cu-SAR-bisPSMA over approved standard-of-care products, with trial sites reporting persistent outreach to enrol more patients despite the additional demands of participating in a clinical trial compared to using already-approved alternatives.
AMPLIFY trial design and regulatory pathway
The AMPLIFY trial evaluates 64Cu-SAR-bisPSMA PET in men with biochemical recurrence of prostate cancer, defined as rising or detectable PSA after initial definitive treatment. The study includes participants with PSA levels above 0.2 ng/mL at clinical sites across the United States and Australia.
The trial design incorporates evaluation across two imaging timepoints to assess diagnostic performance: Day 1 imaging occurs 1-4 hours post-administration (same-day imaging), and Day 2 imaging occurs approximately 24 hours post-administration (next-day imaging). This dual-timepoint assessment aims to demonstrate the agent’s flexibility in clinical practice.
| Trial Element | Detail |
|---|---|
| Trial Name | AMPLIFY |
| ClinicalTrials.gov Identifier | NCT06970847 |
| Phase | III (Registrational) |
| Design | Non-randomised, single-arm, open-label, multi-centre |
| Target Participants | ~220 |
| Locations | US and Australia |
| PSA Inclusion Threshold | >0.2 ng/mL |
| Regulatory Intent | US FDA approval application |
As a pivotal trial, AMPLIFY’s results are intended to provide direct evidence supporting an FDA approval application for 64Cu-SAR-bisPSMA as a diagnostic imaging agent in biochemical recurrence of prostate cancer. The registrational status means successful results would remove a major regulatory de-risking hurdle and provide a clear pathway to commercialisation.
Supporting clinical evidence from COBRA and Co-PSMA trials
The AMPLIFY trial builds on data from two completed studies that evaluated 64Cu-SAR-bisPSMA in prostate cancer patients. The Phase I/II COBRA trial and Phase II Co-PSMA trial both demonstrated enhanced imaging capabilities of 64Cu-SAR-bisPSMA over standard-of-care PSMA PET imaging in patients with biochemical recurrence of prostate cancer.
According to Dr Taylor’s commentary, 64Cu-SAR-bisPSMA achieved a two to three times improvement in lesion detection over standard-of-care in biochemical recurrence patients across these trials. The results constitute an extensive body of evidence demonstrating that maximal clinical benefit of PSMA PET can be derived through the combination of the proprietary SAR-bisPSMA agent and optimised imaging timepoints facilitated by the half-life of copper-64.
To date, Clarity has imaged approximately 600 patients with prostate cancer using 64Cu-SAR-bisPSMA. In the last year alone, the company scanned over 350 patients, reflecting accelerating clinical experience with the agent across multiple trial programmes.
The accumulated dataset across COBRA, Co-PSMA, and now AMPLIFY provides regulatory authorities with substantial evidence of the agent’s performance characteristics in real-world clinical settings, supporting the FDA approval application process.
Clarity’s broader prostate cancer pipeline advances
Clarity Pharmaceuticals (ASX: CU6) is advancing multiple clinical programmes targeting different stages of the prostate cancer care pathway. The CLARIFY Phase III trial (NCT06055830) is evaluating 64Cu-SAR-bisPSMA PET in patients scheduled to undergo radical prostatectomy and pelvic lymph node dissection.
Building on the Phase I PROPELLER study, CLARIFY aims to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET across same-day and next-day imaging in detecting prostate cancer within the pelvic lymph nodes. The trial is expected to close recruitment in CY2026, with results intended to support an FDA approval application for 64Cu-SAR-bisPSMA in prostate cancer patients who are candidates for definitive therapy.
The company is also progressing its theranostic Phase I/IIa SECuRE trial toward completion. This programme evaluates the therapeutic application of the SAR-bisPSMA platform using copper-67, extending the technology beyond imaging into treatment of prostate cancer.
Clarity’s SAR-bisPSMA programmes have received three Fast Track Designations from the US FDA, expediting regulatory review processes and providing opportunities for more frequent interactions with regulatory authorities during clinical development.
Current pipeline status across prostate cancer programmes:
- AMPLIFY (Phase III, biochemical recurrence): Recruitment target achieved
- CLARIFY (Phase III, pre-prostatectomy): Recruitment closing CY2026
- SECuRE (Phase I/IIa, theranostic): Progressing toward completion
- PROPELLER (Phase I): Completed
- COBRA (Phase I/II): Completed
- Co-PSMA (Phase II): Completed
The breadth of the clinical programme positions Clarity to address multiple points in the prostate cancer care pathway, from initial detection in patients scheduled for surgery through to biochemical recurrence and potentially late-stage metastatic disease through the theranostic approach.
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Executive Chairperson on commercial positioning
Dr Alan Taylor emphasised the rarity of Australian biotechnology companies advancing a benchtop discovery through to international Phase III clinical trial completion. The achievement positions Clarity as one of a select group of Australian companies that have successfully navigated this development pathway.
The demand signal from clinicians and patients choosing an unapproved product over approved standard-of-care alternatives indicates market appetite for improved diagnostic accuracy in prostate cancer imaging. Dr Taylor noted that participating sites have maintained persistent outreach to enrol additional patients, with clinicians and patients willing to undertake the additional demands of clinical trial participation rather than rely on findings from current standard-of-care PSMA PET products.
Dr Alan Taylor, Executive Chairperson
“This is no small feat, given we achieved this phenomenal pace of recruitment despite three SOC products already in the market, commercialised by four different companies.”
Management’s focus has shifted to working closely with vendors, participating trial sites and regulatory authorities to advance the final data package toward submission. Dr Taylor stated the company is committed to getting the product to patients in need as soon as possible, supported by the extensive body of evidence generated from discovery through to multiple completed and ongoing clinical trials.
Addressing a blockbuster market opportunity
Prostate cancer represents a substantial market opportunity as the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide. In the United States specifically, prostate cancer is the second-leading cause of cancer death in American men.
The American Cancer Institute estimates there will be approximately 333,830 new cases of prostate cancer in the US in 2026, with around 36,320 deaths from the disease. This large patient population creates significant addressable market potential for diagnostic imaging agents that demonstrate superior efficacy over existing standard-of-care products.
Clarity is positioning 64Cu-SAR-bisPSMA to grow the existing PSMA PET market through demonstrated clinical differentiation in lesion detection rates, coupled with logistical and supply chain benefits from the copper-64 half-life that enables flexible imaging timepoints. Management believes the combination of impressive efficacy in clinical trials and operational advantages creates the foundation for a blockbuster product opportunity.
The theranostic platform further expands commercial potential by enabling the same targeting mechanism to be used for both imaging with copper-64 and therapy with copper-67, creating multiple revenue streams from a single technology platform across the entirety of the prostate cancer journey.
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