Edmonton-based precision health company Nanostics Inc. has initiated a clinical utility study for its AI-powered ClarityDX Prostate test, marking a significant advancement in prostate cancer diagnostics. The company recently announced the recruitment of its first patient into the study (NCT06678828), which aims to evaluate the test's impact when integrated into standard prostate cancer screening protocols.
The study will enroll 1,074 patients across two prominent Alberta Urology sites: the Prostate Cancer Centre in Calgary, led by Principal Investigator Dr. Eric Hyndman, and the Kipnes Urology Centre in Edmonton, under Principal Investigator Dr. Adam Kinnaird.
Promising Previous Results Drive Further Investigation
ClarityDX Prostate has already demonstrated promising results in a large-scale validation study involving 3,448 patients. That study showed the test could more accurately identify men with aggressive prostate cancer when used as an adjunctive test following an elevated PSA result.
"We're excited to announce the first patient recruited in our ClarityDX Prostate clinical utility study," said John Lewis, CEO of Nanostics. "The study is designed to further support the use of ClarityDX Prostate as an additional tool for prostate cancer screening and support the wide-scale adoption of the test."
Potential to Transform Prostate Cancer Screening
The clinical utility study will specifically measure both the clinical and economic benefits of incorporating the ClarityDX Prostate test into current screening practices. If the new study confirms the findings from the validation study, it could significantly impact how prostate cancer is detected and managed.
Dr. John Dushinski, Chief Medical Officer for the Prostate Cancer Centre, emphasized the potential impact: "If the results of the ClarityDX Prostate validation study hold true for this clinical utility study, a 47% reduction in unnecessary biopsies would be transformative for prostate cancer screening, both for the patient and the healthcare system."
Addressing a Critical Need in Prostate Cancer Diagnostics
Prostate cancer screening currently relies heavily on PSA (prostate-specific antigen) testing, which, while useful, often leads to false positives and unnecessary invasive procedures. The ClarityDX platform technology aims to address this limitation by providing more accurate identification of aggressive prostate cancers that require intervention.
The technology could potentially spare many men from undergoing unnecessary biopsies, which carry risks including bleeding, infection, and anxiety, while ensuring that those with aggressive disease are identified promptly for appropriate treatment.
Study Design and Implementation
The Nanostics-sponsored study will evaluate how the integration of ClarityDX Prostate into the diagnostic pathway affects clinical decision-making, patient outcomes, and healthcare resource utilization. By recruiting patients from two different urology centers, the study aims to generate robust data applicable to diverse clinical settings.
As the study progresses, healthcare providers and patients alike will be watching closely to see if ClarityDX Prostate can deliver on its promise to improve the accuracy of prostate cancer detection while reducing the burden of unnecessary procedures on patients and the healthcare system.
