MyProstateScore Equivalency With and Without DRE

Study Overview
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Brief Summary
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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
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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.

Official Title
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Equivalency of MyProstateScore (MPS) Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: MyProstateScore


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sample collected with preceding DRE, then without<br>All subjects participate in the control and experimental collection event sequentially. The control group will consist of urine samples collected post-DRE, and the experimental group will consist of urine samples collected by the same subjects without preceding DRE. | Diagnostic Test: MyProstateScore<br>* MyProstateScore is a urine-based biomarker test used to predict the risk of clinically significant prostate cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPS equivalency with and without 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. | Study participation will span 8 days | 
| MPS validity rate with and without DRE | 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. | Study participation will span 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarker, tumor, prostate, prostatic neoplasm, prostate-specific antigen, early detection of cancer