A new clinical validation study demonstrated that the 18-gene MyProstateScore 2.0 test using first-catch urine samples without requiring digital rectal examination may effectively identify patients who can safely avoid unnecessary prostate biopsies, while maintaining high sensitivity for the detection of clinically significant prostate cancer.
Researchers evaluated 266 men with a median prostate-specific antigen (PSA) of 6.6 ng/mL who were considering prostate biopsy. MyProstateScore 2.0 (MPS2) improved biopsy avoidance compared to PSA testing and the Prostate Cancer Prevention Trial risk calculator (PCPTrc). The team published these findings in The Journal of Urology.
At 92% sensitivity for grade group ≥ 2 (GG ≥ 2) disease detection, MPS2 would have avoided 36% to 42% of unnecessary biopsies in men undergoing initial biopsy, and 44% to 53% of repeat biopsies, compared to 13% and 2.6% with PCPTrc, respectively, wrote the authors. In patients considering repeat biopsy, MPS2 testing would have avoided 44% to 53% of unnecessary biopsies vs only 2.6% with PCPTrc.
"Using first-catch urine, MPS2 meaningfully improved the proportion of biopsies avoided relative to PCPTrc while maintaining highly sensitive detection of GG ≥ 2 cancer," wrote lead author Jeffrey J. Tosoian, MD, MPH, of Vanderbilt University Medical Center, and colleagues. "Non–digital rectal examination (DRE) testing provides a convenient, objective, and highly accurate testing option to reduce the need for imaging and biopsy in men with elevated PSA."
The study also evaluated three MPS2 models: biomarkers alone, biomarkers plus clinical factors, and biomarkers with clinical factors and prostate volume. The area under the curve for detecting GG ≥ 2 cancer was 57% for PSA; 62% for PCPTrc; and 71%, 74%, and 77% for the three MPS2 models, respectively. These findings demonstrate that incorporating clinical factors and prostate volume improved risk stratification beyond biomarker analysis alone.
Among 47 patients undergoing prebiopsy magnetic resonance imaging (MRI), MPS2 detected 95% of GG ≥ 2 cancers vs 79% for MRI. When both tests were negative, no GG ≥ 2 cancers were found.
Study limitations included a low proportion of patients undergoing prebiopsy MRI, lack of data on the combined role of MPS2 and MRI, and limited representation of African American men. The reliance on systematic biopsy as the reference standard may have also introduced undersampling bias. The authors noted further investigation is needed in specific subpopulations, including African American men.
The findings suggest MPS2 testing without DRE requirement could provide a practical first-line test after PSA to help determine the need for more invasive procedures while maintaining reliable detection of clinically significant prostate cancer.
The authors declared having no competing interests.
