A More Accurate Way to Predict the Risk of Aggressive Prostate Cancer
Summary
- Researchers at the Desai Sethi Urology Institute presented a study at AUA2025 that could be a game changer in prostate cancer risk stratification.
- The findings pave the way for a noninvasive urine test that can accurately place prostate cancer patients into risk categories.
- DSUI researchers hope to move the test to the clinics in the near future and herald it a noninvasive way to detect prostate cancer risk.
Researchers at the Desai Sethi Urology Institute (DSUI) at the University of Miami Miller School of Medicine presented a study at the world’s largest gathering of urologists, AUA2025, that could be a game changer in prostate cancer risk stratification.
The findings pave the way for a noninvasive urine test that significantly surpasses other tests such as PSA and MRI to accurately stratify prostate cancer patients into risk categories. Data presented at the meeting is advancing personalized prostate cancer care and potentially less invasive testing for men whose prostate findings are insignificant.
A Different Kind of Prostate Cancer Test
The test is different than any test studied to date because it involves multiple components of genomic testing that go beyond genomic profiling of exosomes in urine.
“Exosomes are a treasure chest of information enveloped in cells,” said study author Omri Nativ, M.D., a urologic oncology and robotic surgery fellow at DSUI.
While there is a urine-based genetic test that helps predict prostate cancer risk, the test in this study casts a much wider net. It analyzes not only genomics, including DNA and RNA, but also transcriptomics, epigenetic changes and proteomics. DSUI researchers used artificial intelligence and machine learning to finetune the data into actionable information.
“This is a subgroup analysis of the Marker Driven Selection of Patients for Prostate Biopsy and Management (MDSelect) clinical trial at DSUI, a trial looking at different ways of measuring biomarkers and using technology to better predict prostate cancer risk,” said principal investigator Sanoj Punnen, M.D., a professor of urologic oncology and vice chair of research at the Miller School. “To my knowledge, DSUI is the first group to study a urine test on exosomes that analyzes multiple biomarker platforms in prostate cancer risk stratification.”
Using AI to Analyze Prostate Data
The National Institutes of Health (NIH)-funded study presented at AUA was an analysis of 106 men older than 50 years of age, with PSAs between 2 nanograms per milliliter to 10 nanograms per milliliter. In addition to PSA testing and prostate biopsies, men had imaging with multiparametric MRI (mpMRI) and the urine test. The researchers used AI to quickly and accurately identify trends in the data to stratify high- and low-risk patients.
They found that each platform, individually, managed to achieve between 75% and 86% accuracy, according to Dr. Nativ.
What’s nice about the urine biomarker test is that it is independent of any clinical parameters, including PSA. Instead of focusing on a tumor’s appearance, it focuses on the tumor’s behavior.
Dr. Omri Nativ
“That’s significant, given PSA is only about 50% to 55% accurate—basically a coin toss about whether one does or does not have prostate cancer that requires further testing and treatment,” he said.
When they combined results from all the platforms (genomics, proteomics, etc.), the researchers noted 95% accuracy for the detection of clinically significant prostate cancer.
“That’s incredible, in terms of prostate cancer diagnosis,” Dr. Nativ said.
According to the study, the urine test was more accurate than MRI and other validated risk calculators.
“With other urine tests, patients need to have a rectal examination prior to testing. Using this testing approach, patients don’t need a rectal exam,” Dr. Nativ said. “Another benefit is that we can capture the exosomes needed in the first void, so it’s easy for the patients to adhere to the testing.”
Personalizes Prostate Medicine
DSUI researchers have since doubled recruitment to almost 200 patients and will continue their analyses in the hopes of translating use of the noninvasive urine test to the clinic in the near future.
“This test could give us the confidence we need to proceed with or without more invasive testing and treatment,” Dr. Nativ said. “What’s nice about the urine biomarker test is that it is independent of any clinical parameters, including PSA. What that means is that, instead of focusing on a tumor’s appearance, it focuses on the tumor’s behavior, or aggressiveness. We believe that is the future of delivering personalized medicine.”
Tags: cancer research, cancer screening, Desai Sethi Urology Institute, Dr. Sanoj Punnen, Newsroom, prostate cancer