MyProstateScore Equivalency With and Without DRE

NCT05700370 | Unknown FDA Device

• 1 other identifier: Equivalency-Study-001
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Sample collected with preceding DRE, then without

EXPERIMENTAL

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

Interventions

MyProstateScore DIAGNOSTIC_TEST

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

Sample collected with preceding DRE, then without

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Prior diagnosis of prostate cancer

Sponsors & Collaborators

• LynxDx: lead

Study Sites (1)

Arizona State Urological Institute

Phoenix, Arizona, 85044, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Pratik Patel, MD

  Arizona State Urological Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: In accordance with the commercially available process
• Access Criteria: In accordance with the commercially available process

Locations

US (1)