Retrospective, Evaluator-Blinded, Pilot and Pivotal Clinical Trials: Assessing the mirCaP Kit (hsv2-miR-H9/has-miR-3659) as a Diagnostic Marker for Prostate Cancer in Patients with PSA Gray Zone Levels

Abstract PSA remains a key biomarker for the diagnosis and monitoring of prostate cancer (PCa). The positive predictive value (PPV) of PSA for PCa detection via biopsy is estimated to be between 30-42% for patients within the PSA gray zone. We conducted a single-center, retrospective, evaluator-blinded, pilot, and pivotal clinical trial to assess the clinical performance of the mirCaP kit (hsv2-miR-H9/has-miR-3659) in aiding physicians’ decision-making for PCa assessments in patients within this gray zone. In the initial clinical trial group, among patients in the PSA gray zone, the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value were 94.29%, 77.50%, 85.33%, 78.57%, and 93.94%, respectively. In the pivotal clinical trial, these values were 94.50%, 82.73%, 87.90%, 81.10%, and 95.04%, respectively. These results suggest that the mirCaP kit may serve as an effective non-invasive diagnostic marker for PCa in patients within the PSA gray zone. The mirCaP kit appears to be a promising tool for guiding decisions regarding prostate biopsy in these patients. Notably, the negative predictive value was over 90%, indicating that in the PSA gray zone, the mirCaP kit could reduce the need for more than 90% of unnecessary prostate biopsies.