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MPS2 test validated for detection of high-grade prostate cancer in non-DRE urine
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Key Takeaways
- MPS2 test detects 94% of GG2 or higher prostate cancers using non-DRE urine samples, outperforming PSA and PCPTrc in accuracy.
- MPS2 models could reduce unnecessary biopsies by 36% to 42%, compared to 13% with PCPTrc, enhancing patient management.
“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," says Ganesh S. Palapattu, MD, FACS.
The 18-gene MyProstateScore 2.0 (MPS2) test demonstrated high sensitivity in the detection of grade group 2 (GG2) or higher prostate cancer using first-catch, non-digital rectal exam (DRE) urine.1
The MPS2 test builds on the original MPS test.
The results were published in the Journal of Urology.
The urine-based test was previously validated and shown to be effective in identifying GG2 or higher cancers in a study published in April 2024.2 That study, however, used urine samples that were obtained following a digital rectal exam (DRE).
“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,” explained co-author Ganesh S. Palapattu, MD, FACS, a professor of urology at the University of Michigan, Ann Arbor in a news release on the findings.3
For the current study, investigators obtained first-catch urine samples from patients prior to biopsy. MPS2 models were assessed in 3 scenarios based on the clinical information included: biomarkers alone (BA; no clinical data), biomarkers and clinical factors (BA + CF), and biomarkers, clinical factors, and prostate volume (BA + CF + PV). The performances of the MPS2 models were then compared with that of prostate-specific antigen (PSA) and the Prostate Cancer Prevention Trial risk calculator (PCPTrc).
In total, the study included 266 men who had a median PSA level of 6.6 ng/mL. Of those, 39% (n = 103) showed GG2 or higher cancer on biopsy.
Overall, the MPS2 test was able to detect 94% of GG2 or higher cancers. The test was also more accurate than other risk assessments, with an area under the curve for GG2 or higher cancer of 57% for PSA, 62% for PCPTrc, and 71%, 74%, and 77% for the MPS2 models, respectively.
The authors added, “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.”
Additionally, the MPS2 test would have avoided 44% to 53% of repeat biopsies vs 2.6% with PCPTrc in patients with a prior negative biopsy.
Palapattu added, “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.”3
According to the news release, the next steps of this study would involve repeating the assessment in a larger, diverse population of patients.
Prior data on MPS2
The MPS2 test builds on the original MPS test, which includes PSA, the gene fusion TMPRSS2::ERG, and another marker called PCA3.4 Although this test was effective in detecting prostate cancer, there was a need to further refine the model to indicate if a patient has high-grade or clinically significant prostate cancer vs GG1 disease.
Data on the MPS2 test were shared in JAMA Oncology in April 2024.2 In that study, the MPS2 test was developed through an RNA sequencing analysis of 58,724 genes that identified 54 markers of prostate cancer, 18 of which were uniquely overexpressed in high-grade tumors. The resulting model was developed both without prostate volume (MPS2) and with prostate volume (MPS2+).
In validating the MPS2 models, 151 of 761 (20.3%) men included in the study were shown to have high-grade prostate cancer on biopsy. The area under the receiver operating characteristic curve was 0.60 for PSA alone, 0.66 for the PCPTrc, 0.77 using the Prostate Health Index, 0.74 with the original MPS model, 0.81 using the MPS2 model, and 0.82 using the MPS2+ model.
Using a 95% sensitivity, MPS2 would have avoided 35% to 42% of unnecessary biopsies in the initial biopsy population, compared with 15% to 30% reductions with the other tests. In the repeat biopsy scenario, MPS2 testing could have avoided 46% to 51% of unnecessary biopsies vs 9% to 21% with the other tests.
The MPS2 models also showed a NPV of 95% to 99% for GG2 or higher cancers and an NPV of 99% for GG3 or higher cancers across pertinent subgroups.
References
1. Tosoian JJ, Zhang Y, Meyers JI, et al. Clinical validation of MyProstateScore 2.0 testing using first-catch, non-digital rectal examination urine. J Urol. 2025:101097JU0000000000004421. doi:10.1097/JU.0000000000004421
2. Tosoian JJ, Zhang Y, Xiao L, et al. Development and validation of an 18-gene urine test for high-grade prostate cancer. JAMA Oncol. 2024;10(6):726-736. doi:10.1001/jamaoncol.2024.0455
3. Urine-based test detects aggressive prostate cancer. News release. Michigan Medicine – University of Michigan. January 28, 2025. Accessed January 30, 2025. https://www.michiganmedicine.org/health-lab/urine-based-test-detects-aggressive-prostate-cancer
4. New urine-based test detects high grade prostate cancer. News release. April 18, 2024. Accessed January 30, 2025. https://www.michiganmedicine.org/health-lab/new-urine-based-test-detects-high-grade-prostate-cancer
