Urinary Molecular Biomarker Test Impacts Prostate Biopsy Decision Making in Clinical Practice

Area of Science:

• Urology
• Molecular Diagnostics
• Oncology

Background:

• Noninvasive methods are needed to identify patients at high risk for clinically significant prostate cancer.
• SelectMDx is a validated molecular urine test for detecting Gleason score 7+ cancers (ISUP Grade Group 2-5).

Purpose of the Study:

• To evaluate the impact of the SelectMDx test on prostate biopsy decision-making in community urology practices.
• Assess the test's clinical utility in real-world settings.

Main Methods:

• A multicenter trial involving 5 U.S. urology practices.
• 418 patients undergoing evaluation for initial prostate biopsy were enrolled.
• Biopsy and prostate cancer detection rates were compared between SelectMDx positive and negative results.

Main Results:

• 61% of patients had SelectMDx negative results, and 39% had positive results.
• Biopsy rates were 60% for positive results vs. 12% for negative results (p <0.001).
• Cancers, including those greater than Grade Group 2, were identified in 43% of biopsied positive cases.

Conclusions:

• SelectMDx significantly influenced prostate biopsy decisions in clinical practice.
• The test demonstrated substantial clinical utility by increasing biopsy rates for positive cases.
• Real-world data supports SelectMDx's role in managing patients evaluated for prostate cancer.