The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE.

The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE. In order to do so, we will perform a crossover study in which each subject provides a sample under both conditions.

Inclusion Criteria:

• Patient is a candidate for prostate biopsy (Bx)
• If Bx naïve and ≤75yo then PSA 3-10 ng/mL
• If Bx naïve and >75yo then PSA 4-10 ng/mL
• If prior negative Bx then PSA may exceed 10 ng/mL
• If DRE very suspicious, then PSA below the thresholds of 3 ng/mL (≤75yo) and 4 ng/mL (>75yo) are acceptable

Exclusion Criteria:

- Prior diagnosis of prostate cancer

MPS results from the post-DRE urine sample will be reported to the provider, consistent with current commercially available processes. Results from the experimental sample collected without a preceding DRE will not be reported to the subject or their provider.

In accordance with the commercially available process

In accordance with the commercially available process