MyProstateScore Equivalency With and Without DRE

NCT ID: NCT05700370

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Sample collected with preceding DRE, then without

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.

Group Type: EXPERIMENTAL

MyProstateScore

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

MyProstateScore

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

LynxDx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pratik Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona State Urological Institute

Locations

Arizona State Urological Institute

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

Equivalency-Study-001

Identifier Type: -

Identifier Source: org_study_id