Equivalency of MyProstateScore (MPS) Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 800
- Locations
- 2
- Primary Endpoint
- MPS equivalency with and without DRE
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
MPS equivalency with and without DRE
Time Frame: Study participation will span 8 days
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.
MPS validity rate with and without DRE
Time Frame: Study participation will span 8 days
Rate of invalid test result equivalency in post-DRE versus non-DRE paired urine samples. Rate will be measured as the percentage of subjects who return an invalid urine sample.
Secondary Outcomes
No secondary outcomes reported