ClarityDX Prostate Utility Trial Enrolls First Patient
The first patient has been enrolled in a trial evaluating ClarityDX Prostate’s impact on early prostate cancer detection, biopsy reduction, and healthcare efficiency.
3D rendering of prostate cancer
The first patient with prostate cancer has been enrolled in the recently launched clinical utility study (NCT06678828) of ClarityDX Prostate.1
The randomized, 2-arm, control trial, which is evaluating the addition of ClarityDX Prostate to standard of care (SOC) for prostate cancer screening, plans to enroll 1074 patients from 2 Alberta Urology sites. Experts aim to quantify the clinical and economic impact of incorporating ClarityDX Prostate to SOC for the early detection of prostate cancer.2
Enrollment is open to male patients aged 18 years and older who were referred to urology for suspicion of prostate cancer. Patients must have not had a prior diagnosis of prostate cancer.
The primary end point is to address the clinical utility of ClarityDX Prostate. Secondary end points are to evaluate the effect of ClarityDX Prostate on the proportion of negative biopsies and biopsies diagnosing Gleason Grade <2, measure the difference in MRI numbers between the test and control arms, evaluate ClarityDX Prostate’s effect on the prioritization of health care services to patients with high risk of having clinically significant prostate cancer, assess ClarityDX Prostate’s potential for prostate cancer screening to inform urology referral, and perform a health economics assessment and cost-benefit analysis for the platform.
"We're excited to announce the first patient recruited in our ClarityDX Prostate clinical utility study," said John Lewis, chief executive officer of Nanostics, in a press release.1 "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."
ClarityDX Prostate is a clinically validated, machine learning-driven decision support tool that was designed to improve the risk assessment of clinically significant prostate cancer. By integrating clinical data with multiple blood-based prostate-specific antigen (PSA) test results, ClarityDX Prostate generates an individualized prostate cancer risk score. This tool supports clinical decision-making at various points in the patient care pathway, particularly in guiding the decision to proceed with prostate biopsy.3
The performance of ClarityDX Prostate was validated in a large-scale, 3448-patient study.1 The results demonstrated that using ClarityDX Prostate as an adjunctive test following an elevated PSA could more accurately identify patients at risk of aggressive prostate cancer.4 This earlier identification enables timely intervention while also mitigating the risks of overdiagnosis and overtreatment associated with nonclinically significant prostate cancer.
According to these data published in Nature Digital Medicine, the accuracy of ClarityDX Prostate showed promise in predicting the risk of clinically significant (grade 2 or higher) prostate cancer in patients before biopsy in the pre-mpMRI setting. In the validation cohort, the test achieved a sensitivity of 95%, specificity of 35%, positive predictive value of 54%, and a negative predictive value of 91% (at a ≥25% risk threshold). Further, at this threshold, up to 35% of unnecessary biopsies could be avoided using this machine learning platform.
Overall, ClarityDX Prostate demonstrated superior predictive accuracy for clinically significant prostate cancer vs PSA testing alone and existing model-based risk calculators. When used as a reflex test in men with elevated PSA levels, the platform has shown to offer valuable decision-making support for clinicians and patients in determining the necessity of proceeding with a prostate biopsy.
"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," added John Dushinski, MD, chief medical officer for the Prostate Cancer Centre, in the press release.1
