A BIOMARKER URINE TEST for men with elevated protein-specific antigen (PSA) could help prevent unnecessary and repeat biopsies without a digital rectal exam, according to a study published in the January 2025 issue of the Journal of Urology.
MyProstateScore 2.0 (MPS2) identifies 18 cancer-specific genes to provide a personalized risk assessment for prostate cancer, particularly for men with elevated PSA, a protein produced by cells in the prostate gland that may be higher in men with cancer. Although there is no single standard for what counts as a high result, a PSA level above 4.0 ng/mL is generally considered abnormal, and a person with an abnormal score may be recommended for a prostate biopsy, according to the National Cancer Institute.
In the study, urine samples were collected from 266 men with a median PSA of 6.6 ng/mL. None of the patients had a digital rectal exam before urine collection. “Once part of a standard workup for elevated PSA, a digital rectal exam before PSA testing is now considered optional in clinical practice,” says Jeffrey J. Tosoian, a urologic oncologist at Vanderbilt University Medical Center in Nashville, Tennessee.
MPS2 test results from the urine samples were compared with the participants’ PSA level and results of a Prostate Cancer Prevention Trial risk calculator, a standard online tool that uses clinical data, including a patient’s PSA, age, race, family history of prostate cancer, results of a digital rectal exam and biopsy status to aid decisions about prostate cancer risk in men considered eligible for prostate biopsy by a urologist.
Focus on High-risk Prostate Cancers
In the study, an MPS2 score below 11.5% was considered negative. Patients who scored below that threshold could forgo biopsy because there was a low risk of prostate cancer that was Grade Group 2 or higher, which would indicate a more aggressive cancer. Using that threshold and comparing it with patients’ PSA and prostate cancer risk calculator data, the study found that use of the MPS2 biomarker urine test could prevent between 36% and 42% of unnecessary biopsies and 44% to 53% of repeat biopsies in study participants who previously had a negative biopsy result.
“MyProstateScore 2.0 allows for greater focus on men likely to have a higher risk of prostate cancer and allows those found unlikely to have a higher risk of prostate cancer to avoid surgical biopsy, although they should continue to be followed by their doctor,” says Tosoian, the study’s lead researcher. The test wasn’t perfect. It directed 7.6% of men in the study with clinically significant prostate cancer away from biopsy. Still, it’s a small percentage compared with the number of unnecessary and repeat biopsies the test helped prevent, he says.
Read more about screening and the factors that affect prostate cancer treatment decisions.
In some men, a negative MPS2 score will simply delay the need for biopsy and a diagnosis of prostate cancer, which will reveal itself over time, Tosaian says. It’s important to discuss with your doctor when to follow up, which will involve monitoring your PSA and possibly a repeat MPS2 test, he says. “The lower a patient’s baseline risk, the more comfortable we are spreading things out,” Tosoian says. “But for patients who are borderline on whether to perform biopsy or not, we’ll often follow up in six to 12 months.”
National Comprehensive Cancer Network guidelines for prostate cancer early detection recommend magnetic resonance imaging (MRI) or biomarker testing for men with elevated PSA levels.
“Many consider a high-quality MRI of the prostate the best test to determine if a biopsy is needed in men with elevated PSA. However, this can be costly and is not always available,” says Justin R. Gregg, a urologist at the University of Texas MD Anderson Cancer Center in Houston, who was not involved with the study. “But a biomarker test like MyProstateScore 2.0 has a lot of promise. I can see a future in which you start with one of these biomarker tests and then go onto MRI as a subsequent workup if it’s indicated, especially for those who don’t have easy access to high-quality MRI.”
MyProstateScore 2.0, which was validated in a study published in the April 2024 issue of JAMA Oncology, has been available for at-home use since February 2025. With a clinician’s order, a kit can be sent directly to patients’ homes and sent back for processing. The test is covered by Medicare and most private insurance. “Without the need for a digital rectal exam, urine biomarker testing improves access to prostate cancer screening as a telehealth option, which can be more convenient for patients living in rural areas,” Tosoian says.
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