Clarity Pharmaceuticals Launches Phase III AMPLIFY Trial for Prostate Cancer Recurrence Detection

On May 20, 2025, Clarity Pharmaceuticals (ASX: CU6) announced the commencement of its registrational Phase III AMPLIFY trial designed to improve diagnostic outcomes for prostate cancer patients experiencing biochemical recurrence. This clinical stage radiopharmaceutical company is focused on developing innovative diagnostics that hold significant promise for cancer treatment.

Overview of the AMPLIFY Trial

The AMPLIFY trial, officially designated as NCT06970847, will evaluate the performance of 64Cu-SAR-bisPSMA during Positron Emission Tomography (PET) scans in patients who show detectable levels of prostate-specific antigen (PSA) following definitive treatment. This non-randomized, single-arm, open-label study will be applicable across multiple clinical sites in the United States and Australia, aiming to enroll around 220 participants.

With the trial beginning at the XCancer clinical site in Omaha, Nebraska, imaging is expected to commence within weeks. The two imaging time points under evaluation will be Day 1 (same-day imaging) and Day 2 (next-day imaging), to determine the efficiency of 64Cu-SAR-bisPSMA in identifying prostate cancer recurrence accurately.

Importance of Accurate Prostate Cancer Diagnostics

The need for advanced diagnostic modalities in prostate cancer has been underscored by recent high-profile cases, including that of former US President Joe Biden, who is now battling aggressive prostate cancer that has metastasized. Such cases highlight the urgency and necessity of accurate and timely detection for effective treatment. Approximately 3.3 million men in the US are currently living with prostate cancer, a stark reminder of the widespread impact this condition has.

Dr. Alan Taylor, Clarity’s Executive Chairperson, emphasized the importance of this trial. “We are thrilled to have commenced our second registrational Phase III trial using the optimized SAR-bisPSMA agent. The need for improved diagnostic approaches is clear, especially for patients whose cancer may return after initial treatment,” he stated.

The Science Behind SAR-bisPSMA

The trial utilizes SAR-bisPSMA, a unique agent that combines two prostate-specific membrane antigen (PSMA) targeting agents with Clarity's proprietary SAR technology. This technology secures copper isotopes in a cage-like structure that minimizes leakage, aiming for safer imaging with 64Cu for PET scans and 67Cu for therapeutic applications. Preliminary studies have already indicated a promising safety profile and enhanced diagnostic performance compared to traditional standard of care imaging.

In previous trials, such as the Phase I/II COBRA trial, 64Cu-SAR-bisPSMA showed superior results in identifying cancer lesions over conventional scans. For instance, it successfully detected lesions with sizes down to 2 mm and did so earlier than existing PSMA PET agents, which is crucial for timely therapeutic intervention.

Future Trials and Development Plans

Looking forward, the AMPLIFY trial is just one of several ongoing projects for Clarity Pharmaceuticals. Plans for concurrent trials include a Phase III study in pre-prostatectomy patients and an ongoing head-to-head comparison between 64Cu-SAR-bisPSMA and traditional 68Ga-PSMA-11 imaging agents.

The recognition from the FDA with three Fast Track Designations for the SAR-bisPSMA agent further underscores the potential of this imaging modality, aiming to revolutionize prostate cancer management from initial diagnosis through its later stages.

Dr. Taylor also expressed gratitude towards the clinicians and patients involved in their trials, reiterating the commitment to advancing cutting-edge products that will reshape the future landscape of prostate cancer treatment. “Identifying recurrences early can empower clinicians to make more informed decisions regarding treatment regimens and ultimately enhance long-term outcomes for patients,” he remarked.

Conclusion

As the AMPLIFY trial progresses, its findings could potentially provide a new standard in diagnosing prostate cancer recurrences. Clarity Pharmaceuticals is on a path to implementing fast-tracked, innovative solutions to address the pressing needs of patients battling this widespread disease.