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Urine-Based Biomarker Test Detects Clinically Significant Prostate Cancer

The urinary 18-gene MyProstateScore 2.0 (MPS2) test can detect clinically significant prostate cancer and reduce the frequency of biopsies compared with the Prostate Cancer Prevention Trial risk calculator (PCPTrc), investigators report.

"The MyProstateScore 2.0 test measures 18 cancer-associated and high-grade cancer-associated genes in urine to provide a percentage likelihood of detecting GG ≥ 2 cancer on biopsy," Jeffrey J. Tosoian, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tennessee, and colleagues explained in The Journal of Urology.

"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 team previously validated the test using post-DRE urine. In the current study, they tested MPS2 as a first-line noninvasive test after serum PSA screening using first-catch, non-DRE urine. They tested 3 MPS2-based models: biomarkers alone (1), biomarkers and clinical data including, age, race, PSA, DRE findings, family history, and prior negative biopsy (2), and biomarkers combined with clinical factors and prostate volume (3).

Among 266 men with a median PSA of 6.6 ng/mL, grade group 2 or higher cancer was eventually diagnosed in 103 men (39%), including 83, 9, and 11 men with GG2, GG3, and GG4-5 disease, respectively. Median MPS2 values were significantly higher in patients with vs without GG 2 or higher cancer in model 1 (31% vs 15%), model 2 (36% vs 15%), and model 3 (41% vs 13%), Dr Tosoian's team reported. MRI use did not differ between groups with and without GG 2 or higher cancer: 18% vs 17%.

The MPS2 models outperformed PSA alone and the PCPT risk calculator, they added. The area under the curve (AUC) for the 3 MPS2 models was 71%, 74%, and 77%, respectively, compared with 57% for PSA and 62% for the PCPT risk calculator. Only MPS2 model 1 was not significantly better than the PCPTrc. Model 3 appeared the most discriminative.

Assuming a 92% rate of detecting clinically relevant prostate cancers at initial biopsy, use of MPS2 would have avoided 36% to 42% of unnecessary biopsies, as compared with 13% using the PCPTrc, the investigators reported. In the repeat biopsy setting, MPS2 would have avoided 44% to 53% of unnecessary biopsies, compared with only 2.6% using the PCPTrc, Dr Tosoian's team reported. Systematic biopsy with or without prebiopsy MRI was the reference standard for prostate cancer diagnosis, which is a study limitation.

"Ultimately, the MPS2 tool's superior sensitivity and positive predictive value better stratify patients for invasive confirmatory testing, while sparing those without significant clinical risk," Shreya Thiagarajan and coauthors at Dell Medical School at the University of Texas at Austin wrote in an accompanying editorial.

The team will be investigating MPS2 use in patients undergoing active surveillance for low-grade prostate cancer. If further validated, the MPS2 might enable at-home testing for clinically significant prostate cancer, which would especially benefit remote patients relying on telehealth care.

This article originally appeared on Renal and Urology News

AI Matches The Accuracy Of Expert Radiologists To Detect Prostate Cancer In A Major Multi-centre Clinical Study

Lucida Medical and Hampshire Hospitals NHS Foundation Trust announce the results of a 5-year collaboration. The PAIR-1 study shows that the Pi AI software, now in use in NHS and European hospitals, is the first commercial product of its kind with performance equivalent to that of expert radiologists to detect prostate cancer, the most common cancer in men.

PAIR-1 (Prostate AI Research – 1) is a collaborative research study between 8 NHS Trusts and Lucida Medical, approved by the NHS Health Research Authority and funded by the company. The study partners gathered historical data from over 2,000 patients and used this to develop, train and validate Pi, a software platform that uses artificial intelligence (AI) algorithms to analyse magnetic resonance imaging (MRI) scans to help distinguish clinically significant prostate cancer.

Dr Antony Rix, CEO and Co-Founder at Lucida Medical, highlights that "every year, over 50,000 men in the UK and 1.5 million men worldwide are diagnosed with prostate cancer. The disease may start slowly, but can be deadly if it's not caught early, killing 12,000 men in the UK and 400,000 men around the world each year."

An MRI scan is a key step to diagnose prostate cancer. The MRI is used to help identify patients at low risk who can avoid a painful, invasive biopsy, and to locate possible lesions so that higher-risk patients can have a targeted biopsy to maximise the chance of finding cancers that need treatment. Mark Hinton, CTO at Lucida Medical, explained: "Pi is medical device software that is CE approved for use in clinics. We developed Pi to automate key steps like outlining lesions and calculating risk scores, to assist radiologists to make these challenging decisions."

Dr Francesco Giganti, Associate Professor of Radiology at University College London, presents the results of the PAIR-1 study today at the European Congress of Radiology (ECR) in Vienna. He noted that "this research found that Pi is non-inferior to multidisciplinary team-supported radiologists across a validation set of sequential cases from 6 NHS hospitals with a wide range of MRI scanner types. This is the first time that a commercial AI for prostate MRI has been tested on diverse, real-world data."

Dr Aarti Shah, Consultant Radiologist at Hampshire Hospitals NHS Foundation Trust, was Chief Investigator on the study. She highlighted that "analysing MRI scans is a time-consuming task for expert radiologists, and there are too few of us in the UK and many other countries. Pi offers exciting potential as an aid to help reporting radiologists in triaging workloads as well as producing visual reports to aid contouring of lesions for biopsy."

"We founded Lucida Medical with a shared vision to use AI to transform the diagnosis of cancer. Five years on, it is wonderful to see this working in practice and recognised by a major journal and conference," added Prof Evis Sala, Co-Founder of Lucida Medical, Professor of Radiology at the Università Cattolica del Sacro Cuore and Chair of Department of Diagnostic Imaging and Radiotherapy at the Policlinico Universitario A. Gemelli, IRCCS in Rome.

Pi is available for use in the UK and Europe to support the diagnosis of prostate cancer.

At ECR 2025, Dr Giganti's presentation, AI-powered prostate cancer detection: a multi-centre, multi-scanner validation study, is in session CTiR 16 - Clinical Trials in Radiology: spotlight, in Room N on Feb 28 at 16.00 CET. The research is also published in European Radiology at https://doi.Org/10.1007/s00330-024-11323-0. Lucida Medical is demonstrating Pi at its booth AI-37 in the AI Zone.

Mobile Prostate Cancer Screening Clinic Can ID The Disease In Disadvantaged Men

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