Bladder with prostate and stethoscope or phonedoscope. (Photo by Shidlovski on Shutterstock)
In a nutshell
- A new urine test can detect aggressive prostate cancer without requiring an uncomfortable rectal exam, potentially allowing for at-home sample collection
- In a study of 266 men, the test identified over 92% of aggressive cancers while potentially reducing unnecessary biopsies by up to 42%
- The test looks for 18 specific genes linked to prostate cancer and provides a clear percentage score indicating the likelihood of finding significant cancer
ANN ARBOR, Mich. — Prostate cancer is the second leading cause of cancer for men living in the United States, according to the American Cancer Society. Because of poor reporting, most cases are under-reported until they reach more advanced states. A new at-home urine test developed by Michigan researchers aims to encourage more men to undergo diagnostic testing.
Testing for prostate cancer, while necessary, traditionally involves uncomfortable and invasive procedures. Current screening methods rely on blood tests, MRIs, and biopsies. Additionally, these diagnostic tools often overdiagnose low-grade cancers while struggling to accurately determine how aggressive a tumor might be.
A study published in The Journal of Urology validates a urine test called MyProstateScore 2.0 (MPS2) that searches for 18 different genes associated with prostate cancer. Some of these genes specifically indicate more aggressive forms of the disease.
Prostate cancers are normally scored based on the Gleason Grade or Grade Group. “Gleason 3+4=7,” also called Grade Group 2, are aggressive tumors. They are more likely to grow and cause harm to the body than non-aggressive prostate cancers rated as “Gleason 6” or Grade Group 1.
“Its primary benefit is that the test can accurately predict your probability of developing aggressive prostate cancer, putting both the patient and physician at ease,” says Dr. Ganesh Palapattu, the department chair of urology at Michigan Medicine and study co-author, in a statement.
The researchers noted that previous research had collected urine samples from a digital rectal exam, which would not be practical or comfortable for many people. “The process requires the prostate to be compressed, causing the release of cellular debris into a urine sample that the patient provides after the rectal exam,” explains Dr. Palapattu, who is also a professor of urology.
The new research examined whether the MPS2 test could detect cancer markers without this examination. Using urine samples from 266 men who did not undergo a rectal exam, researchers found the test could identify more than 92% of aggressive prostate cancers (Grade Group 2 or higher) while showing better accuracy than standard blood tests.
The study’s calculations suggest this approach could help 36-42% of men avoid unnecessary biopsies. For men who previously had a negative biopsy but still showed concerning PSA levels, the test could prevent 44-53% of repeat biopsies while maintaining high accuracy for detecting aggressive cancers.
It is also a cost-effective test compared to an MRI, and Dr. Palapattu says it has high potential as an at-home test.
A small group of 47 patients received both MPS2 testing and MRI scans. While this sample was limited, the results suggested the two methods might complement each other, with each test catching some significant cancers the other missed.
To confirm the findings, the team plans to repeat the study with a more diverse and numerous group of male participants. They are also looking to see how effective the urine test is at detecting low-state, non-aggressive prostate cancer.
“MPS2 could potentially improve the health of our patients by avoiding overdiagnosis and overtreatment and allowing us to focus on those who are most likely to have aggressive cancers,” Dr. Palapattu explains. MPS2 is currently available through Lynx Dx, a University of Michigan spin-off company.
Paper Summary
Methodology
The study enrolled 266 men at the University of Michigan between November 2020 and March 2023. All participants provided first-catch urine samples without having a digital rectal exam first. The researchers excluded men with PSA levels above 20 ng/mL for initial biopsies and above 25 ng/mL for repeat biopsies. Each participant underwent a 12-core systematic biopsy, and some also received MRI scans based on their doctor’s judgment. The genetic analysis looked at 18 specific genes, with results calculated using three different models that incorporated varying levels of clinical information.
Results
The study found that 103 participants (39%) had clinically significant prostate cancer. MPS2 testing showed markedly better accuracy than PSA testing alone (57%) or the standard risk calculator (62%), achieving accuracy rates of 71-77% depending on which model was used. At a threshold maintaining 92% sensitivity for detecting significant cancers, MPS2 could have prevented 36-42% of unnecessary biopsies overall and 44-53% in men having repeat biopsies. Importantly, only one patient with high-grade cancer (grade group 3 or higher) had a false negative MPS2 result.
Limitations
The research had several important constraints: Only 47 participants (18%) received pre-biopsy MRI scans, limiting conclusions about combining MPS2 with MRI. Most cases relied on systematic biopsy rather than targeted sampling, which might miss some cancers. The study population included limited numbers of African American men and men with suspicious digital rectal exam findings. Additionally, while the test showed promise for telehealth applications, the study didn’t directly evaluate at-home collection.
Discussion and Takeaways
MPS2 testing represents a significant advance in prostate cancer screening by providing accurate risk assessment without requiring a digital rectal exam. The test’s flexibility in working with varying levels of clinical information makes it practical for different healthcare settings. Its particularly strong performance in men facing repeat biopsy decisions could help address a challenging clinical situation. The potential for at-home collection could make screening more accessible, though further research is needed to validate this approach.
Funding and Disclosures
This research received funding from several sources, including the Michigan-Vanderbilt Early Detection Research Network Biomarker Characterization Center, the Prostate Cancer Foundation Young Investigator Award, the Michigan Prostate Specialized Program of Research Excellence, and other cancer research grants. The study authors declared no conflicts of interest, and all participants provided written informed consent under approved institutional review board protocols.
Publication Information
This research appears in The Journal of Urology’s May 2025 issue. The multi-institutional study was led by Jeffrey J. Tosoian and colleagues from Vanderbilt University Medical Center, University of Michigan, Northwestern University, and other institutions. The work represents a collaborative effort across multiple major academic medical centers to validate this new testing approach.
