Experimental prostate Ca urinary test outperforms PSA
One prostate cancer expert told Urology Times that while the assay shows promise, head-to-head studies are needed to compare tests such as IntelliScore with currently available tests to determine who best benefits from each test.
The urinary three-gene expression assay noninvasively discriminates among high-grade Gleason score ≥7, and low-grade Gleason 6 cancer, and benign disease by detecting RNA from three genes, ERG, PCA3, and SPDEF, which are associated with prostate cancer development and progression.
For the study, which was published online in JAMA Oncology (March 31, 2016), researchers compared prostate biopsy results from 774 men with PSA levels between 2.0 ng/mL and 10.0 ng/mL with a composite score based on results of the urine test, along with PSA level, age, race, and family history of prostate cancer. They then set a cut-off score of 15.6, based on the use of data from 255 of the men, which showed that score identified more than 90% of men with high-grade cancer. To study the test’s accuracy, the authors used the 15.6 score on the remaining 519 men to predict who had high-grade cancer versus low-grade cancer or no disease.
They reported the urine exosome assay identified 92% of men with high-grade cancer. The test also predicted high-grade cancer in 66% of men whose biopsies revealed low-grade or no cancer. Using the cut-off score, 27% of biopsies (138 of 519) would have been avoided.