A new genetics-driven urine test has demonstrated remarkable accuracy in identifying aggressive prostate cancer, potentially transforming how physicians approach prostate cancer diagnosis and management. The test, called MyProstateScore 2.0 (MPS2), can now be performed at home without requiring a prior digital rectal examination.
Researchers from the University of Michigan recently published findings in The Journal of Urology showing that MPS2 detected 94% of aggressive prostate cancers, outperforming traditional PSA blood tests in sensitivity. The study evaluated 266 men who had not undergone digital rectal examinations prior to urine collection.
"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," said Dr. Ganesh Palapattu, chair of urology at the University of Michigan and co-researcher on the study.
How the Test Works
Unlike the prostate-specific antigen (PSA) test, which measures a protein released by an inflamed prostate, MPS2 examines 18 genes specifically associated with aggressive prostate cancer. This molecular approach provides a critical advantage, as fewer than 25% of men with elevated PSA levels actually have prostate cancer requiring immediate treatment.
The test generates a report estimating the probability of aggressive prostate cancer, with a negative predictive value of 95-99%. This means when the test indicates low risk, physicians can be highly confident that aggressive cancer would not be detected on subsequent biopsy.
Clinical Impact and Biopsy Reduction
The study results demonstrated that implementing MPS2 testing could prevent 36-42% of unnecessary biopsies in the general population while maintaining 92% sensitivity for detecting Grade Group 2 or higher cancers. For men with previous negative biopsies, the test could help 44-53% avoid repeat procedures.
"This test has the ability to hone in and refine our focus on individuals at high risk for developing aggressive prostate cancer, and also allows us to provide reassurance and de-escalate surveillance for men unlikely to have high-risk prostate cancer," Dr. Palapattu told Healio. "This has significant ramifications for cost, as well as for patient comfort and anxiety."
Addressing the Overdiagnosis Problem
Prostate cancer diagnosis currently faces a significant challenge of overdiagnosis and overtreatment. Many prostate cancers detected through PSA screening are indolent and unlikely to cause harm, yet their diagnosis often leads to treatments that can cause serious side effects like incontinence and impotence.
The current diagnostic pathway typically involves PSA testing followed by MRI and biopsy. However, MRIs miss approximately 15-20% of aggressive prostate lesions and face limitations in accessibility, equipment quality, and expert availability.
"As urologists, our goal is to identify cancers that are likely to be aggressive so we can focus treatment on those who need it and avoid harming those who don't need it," explained Dr. Palapattu.
At-Home Collection Now Available
Following the study's publication, Lynx Dx, the manufacturer of MPS2, announced that the test is now available for at-home collection sampling. This development significantly improves accessibility and patient convenience.
"[The test] now empowers patients to collect their samples in the comfort of their homes, a significant step forward in prostate cancer risk assessment and our commitment to patient-centered care," said Dr. Spencer Heaton, chief medical officer at Lynx Dx.
Performance Compared to Current Standards
The study compared MPS2 to both PSA testing and the Prostate Cancer Prevention Trial Risk Calculator (PCPTrc). Results showed areas under the curve for detection of Grade Group 2 or higher cancers at 71%, 74%, and 77% with various MPS2 models, compared with just 57% for PSA testing and 62% for PCPTrc.
This superior performance could help address the limitations of current diagnostic tools. PSA is prostate-specific but not cancer-specific, while MPS2 targets genes specifically associated with aggressive prostate cancer.
Future Research Directions
Researchers are now planning to study the test's ability to monitor men already diagnosed with low-risk prostate cancer who are under active surveillance. Currently, these patients undergo blood tests every six months and biopsies or MRIs every one to two years.
"If we could limit those by introducing this very easy-to-use test, we could have an opportunity to revolutionize the way we manage men with low-risk prostate cancer on active surveillance," said Dr. Palapattu, noting that the vast majority of men diagnosed with prostate cancer in the United States have low-risk disease.
The development of MPS2 represents a significant advancement in prostate cancer diagnostics, potentially reducing unnecessary procedures while ensuring aggressive cancers are detected and treated appropriately. This patient-centered approach could substantially improve quality of life for the millions of men facing prostate cancer concerns annually.
