MyProstateScore Equivalency With and Without DRE

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05700370
• Other study ID #: Equivalency-Study-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: April 2023

Study information

• Verified date: January 2023
• Source: LynxDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Arizona State Urological Institute	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
LynxDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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