Prostate Cancer Clinical Trial
MyProstateScore Equivalency With and Without DRE
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Phoenix Arizona, 85044, United States
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