Clarity Pharmaceuticals Launches Head-to-Head Diagnostic Trial for Prostate Cancer Recurrence

Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company, has announced a new Investigator-Initiated Trial (IIT) to compare the diagnostic performance of its proprietary product, ⁶⁴Cu-SAR-bisPSMA, against the current standard-of-care ⁶⁸Ga-PSMA-11 in detecting prostate cancer recurrence. The trial, known as Co-PSMA, is led by Professor Louise Emmett at St. Vincent’s Hospital, Sydney.

Trial Design and Goals

The Co-PSMA trial is a phase II prospective imaging study enrolling 50 patients experiencing biochemical recurrence (BCR) of prostate cancer following radical prostatectomy. These patients, candidates for curative salvage radiotherapy, will undergo diagnostic evaluation to compare the detection rates of prostate cancer recurrence sites using the two PET/CT imaging agents. The study’s primary objective is to determine the number of detectable lesions per patient with each diagnostic method.

Lead trial investigator Professor Emmett emphasized the importance of accurate imaging for men with rising PSA levels after surgery: “Men with BCR after radical prostatectomy have a window of opportunity for a cure with the use of external beam radiotherapy. In order to achieve that, we need to use highly sensitive imaging techniques that can accurately detect the site of disease recurrence when the prostate-specific antigen (PSA) levels start to rise. This could really help improve patients’ lives.”

Professor Emmett previously led Clarity’s PROPELLER trial, which evaluated ⁶⁴Cu-SAR-bisPSMA in untreated prostate cancer patients, and her work has contributed to the ongoing phase III CLARIFY trial. In addition, Professor Emmett has overseen two other IITs using Clarity’s SAR-Bombesin product for prostate and breast cancer indications.

Dr. Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, expressed enthusiasm for continuing the partnership with Professor Emmett and St. Vincent’s Hospital. “We pride ourselves on good Australian science and adhering to the highest standard for clinical research,” he said. “We look forward to . . . generating data to highlight the benefits of our bisPSMA molecule over the current-generation diagnostics, such as the generic ⁶⁸Ga-PSMA-11.”

Advantages of 64Cu-SAR-bisPSMA

Clarity Pharmaceuticals’ copper-based ⁶⁴Cu-SAR-bisPSMA has shown promising results in prior trials, including the COBRA study, which demonstrated its ability to detect cancer lesions smaller than 2 millimeters and image them more than six months before standard imaging methods. The product’s extended imaging window and logistical advantages over gallium-based diagnostics could provide significant benefits for patients and health care providers.

Dr. Taylor highlighted these attributes, stating, “We know very well that early detection of cancer provides the best opportunities for better treatments, and this capability, coupled with the extended imaging window and logistical advantages, make it an ideal candidate to revolutionize care in these patients.”

The Co-PSMA trial represents a critical opportunity to assess the potential of ⁶⁴Cu-SAR-bisPSMA to improve the diagnostic landscape for men with prostate cancer recurrence. Early and accurate detection of recurrent cancer is crucial for guiding treatment decisions, especially in patients eligible for salvage radiotherapy. If successful, this trial could pave the way for broader adoption of copper-based diagnostic agents and better outcomes for prostate cancer patients worldwide.