A non-invasive urine test could help prevent unnecessary and repeat biopsies without a digital rectal exam (DRE) in men with elevated prostate-specific antigen (PSA) levels, according to new research presented at the annual meeting of the American Urological Society.
The urinary 18-gene MyProstateScore 2.0 (MPS2) provided high sensitivity for the detection of clinically significant prostate cancer. while ruling out 37%-42% of unnecessary biopsies for men undergoing an initial biopsy.
“This suggests that MPs 2 can greatly improve the clinical experience and outcomes of men presenting with an elevated PSA with or without a previous negative biopsy,” said study author Keavash Assani, MD, a urology resident at Vanderbilt University Medical Center, who presented the findings at the meeting. “Importantly, use of urine without requiring a rectal exam expands access to the test, which can now be performed through at home testing, for example, in patients undergoing telehealth care.”
The MPS2 test assesses 18 different genes that have been linked to the development of high-grade prostate cancer. In multiple tests using urine and tissue samples from men with prostate cancer, it was able to successfully identify cancers classified as Gleason 3+4=7 or Grade Group 2 (GG2), or higher. The test had been previously validated using DRE urine, and was shown to preserve detection of clinically significant prostate cancers (GG ≥2) while reducing the rate of biopsies in this population.
“In that study, MPS2 demonstrated highly accurate detection of clinically significant prostate cancer, defined as Gleason score 7 to 10 or Grade group 2 to 5, meaning this includes cancers that generally pose risk of harm and require treatment,” said Dr. Assani. “The study found that MPS2 outperformed other guideline endorsed biomarkers as well as PSA and the PCPT risk calculator, which combines PSA with clinical risk factors.”
However, DREs are uncomfortable for patients and is now considered optional by clinical guidelines.Also of note is that performing DRE is not feasible in the growing population who are now using telehealth consultations. Therefore, to facilitate at-home and remote testing, Dr. Assani and colleagues now validated MPS2 using first-catch, non-DRE urine in patients with elevated PSA levels.
The cohort was comprised of 266 participants with median PSA 6.7 ng/mL First-catch urine was obtained prior to biopsy, and MPS2 values were calculated using three previously established models: biomarkers alone; biomarkers and clinical data including, age, race, PSA, DRE findings, family history; and prior negative biopsy; and biomarkers combined with clinical factors and prostate volume.
The primary goal of the current study was to validate the MPS2 test in urine specimens obtained without DRE and evaluate its clinical performance for detecting GG ≥ 2 prostate cancer. The secondary outcome was detection of GG ≥ 3 prostate cancer. MPS2 was compared to serum PSA and the PCa Prevention Trial risk calculator (PCPTrc), and at test threshold approximating 90% sensitivity, full performance measures and clinical consequences of MPS2 testing were calculated.
Within this cohort, GG ≥ 2 prostate cancer was eventually diagnosed in 108 (40%) men, and GG ≥ 3 was diagnosed in 24 (8.8%) of the participants. The area under the curve (AUC) for GG=2 cancer was 57% for PSA, 62% for PCPTrc, and 71-77% for the MPS2 models.
In addition, negative predictive values (NPVs) were 92%-96% for GG ≥ 2 cancer and 97-100% for GG ≥ 3 cancer across models.
All three of the MPS2 models led to substantial improvements in the number of unnecessary biopsies and avoided biopsies that proved to be negative or detect low grade cancers not requiring treatment. “While use of the risk calculator would have avoided 13% of unnecessary biopsies, the MPS2 models would have avoided between 36 and 42%,” said Dr. Assani.
He pointed out that the “findings were particularly striking in patients with a history of a prior negative biopsy, where the risk calculator would have avoided only 3% of unnecessary biopsies compared with 44 to 53% using MPS2.”
Overall, the current study found that the MPS2 test without prior DRE provides accuracy in line with the post DRE test, and the assay is a convenient, reliable testing option to reduce the use of biopsy in men with elevated PSA.
Source of Funding: NCI-EDRN U2C (CA271854), Prostate Cancer Foundation (20YOUN11), Michigan Prostate SPORE (P50 CA186786), NCI Outstanding Investigator (R35
IP05-29: DIGITAL RECTAL EXAM NO MORE: VALIDATED ACCURACY OFMYPROSTATESCORE 2.0 (MPS2) USING FIRST-CATCH, NON-DRE URINE. Presented Saturday, April 26, 2025 at the 2025 annual meeting of the American Urological Association
Image by imageBROKER/Sigrid Gombert / Getty Images
