In a study reported in the Journal of Urology, Wang et al found that tests for small noncoding RNAs isolated from urinary exosomes accurately distinguished patients with vs without prostate cancer and patients with low- vs intermediate- or high-risk disease.
Study Details
The investigators describe the development and performance of three separate tests:
- The miR SentinelTM PCa test, which distinguishes patients with prostate cancer from persons with no evidence of prostate cancer
- The miR Sentinel CS Test, which distinguishes between low-risk (Grade Group 1) and intermediate- and high-risk disease (Grade Group 2–5)
- The miR Sentinel HG Test, which distinguishes low- and favorable intermediate-risk prostate cancer (Grade Group 1 or 2) from high-risk disease (Grade Group 3–5).
The tests were validated in case-control samples in a training cohort of 836 subjects (268 with no cancer, 568 with cancer) and a testing cohort of 600 subjects (300 with no cancer, 300 with cancer).
Key Findings
In the training cohort, the Sentinel PCa Test showed a sensitivity of 94% and specificity of 96% for predicting presence of cancer (positive predictive value [PPV] = 98%, negative predictive value [NPV] = 88%). The Sentinel CS Test showed a sensitivity of 93% and specificity of 91% for prediction of Grade Group 2 or higher cancer (PPV = 91%, NPV = 93%). The Sentinel HG Test showed a sensitivity of 95% and specificity of 96% for the prediction of Grade Group 3 or higher cancer (PPV = 91%, NPV = 98%).
In the testing cohort, the Sentinel PCa Test demonstrated a sensitivity of 94% and specificity of 92% for predicting presence of cancer (PPV = 92%, NPV = 94%). The Sentinel CS Test showed a sensitivity of 93% and specificity of 90% for prediction of Grade Group 2 or higher cancer (PPV = 91%, NPV = 92%). The Sentinel HG Test showed a sensitivity of 94% and specificity of 96% for the prediction of Grade Group 3 or higher cancer (PPV = 91%, NPV = 97%).
The investigators concluded, “In this comprehensive evaluation of the urinary exosome–based miR Sentinel PCa, CS, and HG Tests, high accuracy for identifying the presence of cancer and the presence of high-grade cancer was demonstrated. These data demonstrate that the evaluation of a panel of urinary exosomal small noncoding RNAs offers the ability to accurately and noninvasively screen, diagnose, characterize, and monitor prostate cancer.”
Disclosure: For full disclosures of the study authors, visit auajournals.org.
