MyProstateScore Equivalency With and Without DRE

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05700370

Enrollment

800

Registered

2023-01-26

Start date

2022-11-01

Completion date

2023-04-30

Last updated

2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

biomarker, tumor, prostate, prostatic neoplasm, prostate-specific antigen, early detection of cancer

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.

Interventions

DIAGNOSTIC_TESTMyProstateScore

MyProstateScore is a urine-based biomarker test used to predict the risk of clinically significant prostate cancer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MPS equivalency with and without DRE	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	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026