Researchers at the University of Michigan Rogel Cancer Center have announced the development of a novel urine-based test named MyProstateScore2.0 (MPS2), aiming to revolutionize the diagnosis of prostate cancer by identifying high-grade cancers that require immediate intervention.

Reporting in JAMA Oncology, the new test could significantly decrease the number of unnecessary biopsies performed each year.

Prostate cancer, one of the most common types of cancer among men, is often detected via prostate-specific antigen (PSA) testing. However, the PSA test has been criticized for its inability to distinguish between aggressive and slow-growing cancers, which has led to unnecessary biopsies and treatments.

According to John T. Wei, MD, co-senior study author and the David A. Bloom Professor of Urology at Michigan Medicine, the landscape of prostate cancer detection has shifted significantly.

“Twenty years ago, we were looking for any kind of cancer. Now we realize that slow-growing cancer doesn’t need to be treated,” Wei explained. This shift in focus is reflected in the design of MPS2, which targets 18 specific genes associated with higher-grade, more aggressive prostate cancers.

MPS2 builds upon the original MyProstateScore test, developed nearly a decade ago following the discovery of a significant gene fusion related to prostate cancer. The original test included markers for PSA, the gene fusion TMPRSS2::ERG, and PCA3, another significant marker.

To enhance the detection capabilities, the new MPS2 test includes these original markers plus an additional 16 biomarkers identified through RNA sequencing of more than 58,000 genes, narrowing down to those uniquely overexpressed in higher-grade cancers.

The development of MPS2 involved analyzing urine samples from approximately 700 patients collected between 2008 and 2020 through the National Cancer Institute’s Early Detection Research Network (EDRN). After rigorous testing, the selected 18 markers consistently correlated with higher-grade diseases. The test’s effectiveness was further confirmed on over 800 urine samples collected nationally, ensuring diverse and representative results.

The outcomes of MPS2 testing are promising, with the test nearly 100% accurate in ruling out low-grade Grade Group 1 (GG1) cancers, which are unlikely to progress.

“If you’re negative on this test, it’s almost certain that you don’t have aggressive prostate cancer,” stated Arul Chinnaiyan, MD, the Hicks Endowed Professor of Pathology and professor of urology at Michigan Medicine.

Crucially, the test could prevent up to 41% of unnecessary biopsies, a significant improvement over the 11% prevention rate with PSA testing alone. For patients who have previously undergone biopsies with negative results, MPS2 offers a reliable method to avoid further invasive procedures.

“Four of 10 men who would have a negative biopsy will have a low-risk MPS2 result and can confidently skip a biopsy,” added Wei.

The researchers believe that the new test not only provides a more accurate diagnosis tool for prostate cancer but also aligns with a broader shift toward precision medicine, where treatments and diagnostics are tailored to individual patient needs.

By reducing unnecessary biopsies, MPS2 can help alleviate the emotional and physical strain associated with cancer screening and potentially lead to more targeted and effective healthcare strategies for men worldwide.