It’s not exactly the ultimate “American Dream” but it’s great news for clarifying a suspicious PSA test result. As we know, the PSA blood test is controversial as a screening tool for prostate cancer (PCa) because an unexpectedly high result can mean any number of things, not just PCa. And yet, on the chance that cancer may be present, a million needle biopsies are done every year in the U.S. alone!
While nearly 700,000 will be negative for PCa, the biopsy is still the only definitive way to diagnose PCa—and doctors understandably don’t want to risk missing it. But since there are risks involved with the needle biopsy (pain/discomfort, infection, blood in urine or semen, erectile dysfunction) the U.S. task force recommends that each man and his doctor decide together if a PSA test is warranted.
Thus, if you can’t trust a PSA result, should you even have the test? Good question. But the facts are, since broad PSA screening is down, the number of men diagnosed with more advanced PCa is up. Why? Because they weren’t screened, which might have led to earlier detection. What a dilemma!
New urine test brings new hope
At last, there’s a simple urine test that can clarify if an abnormal PSA test points to cancer or not. It’s called the MyProstateScore 2.0 (MPS2) test. In clinical tests, it has been shown to predict the likelihood that Grade Group 2 or higher will be found on biopsy. Remember, GG 2 or higher is considered clinically significant prostate cancer (csPCa) that could become life-threatening if left untreated.
Here’s the best part: it’s a simple, noninvasive test. It’s done as a “first-catch” urine sample, meaning capturing urine as soon as the flow starts. It differs from the current PCA3 urine test because the new version does not require a digital rectal exam to massage the prostate prior to peeing into a cup. Thus, no DRE is needed for the MPS2 test—just catch the urine as soon as the stream starts. That’s all there is to it! Then, the sample is sent to a lab for a special analysis that looks for 18 genes linked with PCa, especially high-grade cancer. These are called biomarkers so the MPS2 acts as a liquid biopsy.
In clinical trials involving a biopsy after a urine drop, the MPS2 test was compared with existing post-PSA tests intended to clarify a suspicious PSA result. The MPS2 demonstrated better accuracy at filtering out low-grade cancers than all of them.
The most recently published research is the work of a U.S. multicenter team. The study involved 266 men with an average PSA of 6.6 ng/mL, all of whom had their risk calculated using three methods: their PSA alone, the Prostate Cancer Prevention Trial Risk Calculator (PCPTRC), and the MPS2 test. Then all had a biopsy regardless of their scores. The MPS2 test outperformed the others for predicting which men would have less than GG 2 PCa and therefore would not need a biopsy. According to the published study, “Under a testing approach detecting > 90% of GG ≥ 2 cancers, MPS2 testing would have avoided 36% to 42% of unnecessary biopsies, as compared with 13% using the PCPTrc.”[i]
A recent news article quotes the study, “Using urine obtained without [digital rectal exam (DRE)], the MPS2 test provides a highly accurate, personalized risk score to better identify patients who can confidently forego additional testing with MRI or biopsy.”
The MPS2 test is FDA-approved. According to ProstateCancerMarkers.com, its advantages include:
- Comprehensive: By analyzing the expression of 18 unique gene transcripts, MPS2 offers a comprehensive assessment that surpasses traditional biomarker tests.
- Clinical Flexibility: The test can be utilized as a biomarker-only assessment or combined with optional clinical risk factors, offering tailored insights for diverse patient scenarios.
- Identifying Low-Risk Patients: MPS2 safely identifies 42% to 51% of patients who do not have clinically significant prostate cancer.
- Optimized for Accuracy: MPS2 ensures diagnostic accuracy in both biopsy naïve patients and those with a prior negative biopsy, with NPV 93-99%.
The benefits to patients are obvious, but I want to add an important point. The Sperling Prostate Center has long advocated for annual PSA blood tests as a routine part of men’s healthcare, because there’s no reason to fear that an unusual result will automatically lead to a needle biopsy. We’ve defended the value of the PSA test because a follow-up MRI can reveal whether csPCA is present after a suspiciously light PSA result. The earlier PCa is detected, the more treatment options are open (including Active Surveillance for low-risk disease) and the higher the likelihood that treatment will be 100% successful. Studies have shown that mpMRI can determine if a biopsy is needed or not.
That said, the authors of the above study suggest that the MPS2 test can identify if an MRI is warranted. Our Center still recommends annual PSA testing, with a reminder that there’s no reason to fear a suspicious result thanks to MRI and/or MPS2. By recording each year’s result from baseline onward, conditions like BPH can be tracked. Especially for men with PCa risk factors like age, ethnicity, exposure to toxins, etc., an annual PSA is necessary. The fact that the MPS2 test can help avoid additional anxiety and the costs of imaging and biopsy by singling out low-risk cases is a good thing—but this does not negate the value of the PSA test as the least expensive way to watch for any red flags. We can still say, long live the PSA, long live MRI, and long live the MPS2 follow-up test.
NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you are experiencing pelvic pain, or have any other health concerns or questions of a personal medical nature.
References
[i] Tosoian JJ, Zhang Y, Meyers JI, Heaton S et al. Clinical Validation of MyProstateScore 2.0 Testing Using First-Catch, Non-Digital Rectal Examination Urine. J Urol. 2025 Jan 21:101097JU0000000000004421.
About Dr. Dan Sperling
Dan Sperling, MD, DABR, is a board certified radiologist who is globally recognized as a leader in multiparametric MRI for the detection and diagnosis of a range of disease conditions. As Medical Director of the Sperling Prostate Center, Sperling Medical Group and Sperling Neurosurgery Associates, he and his team are on the leading edge of significant change in medical practice. He is the co-author of the new patient book Redefining Prostate Cancer, and is a contributing author on over 25 published studies. For more information, contact the Sperling Prostate Center.
