MyProstateScore Equivalency With and Without DRE

Sponsor

LynxDx (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05700370

Collaborator

(none)

800

Enrollment

Location

Arm

Anticipated Duration (Months)

161.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: MyProstateScore	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Diagnostic Test: MyProstateScore MyProstateScore is a urine-based biomarker test used to predict the risk of clinically significant prostate cancer

Arm

Intervention/Treatment

Experimental: 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.

Diagnostic Test: MyProstateScore

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona State Urological Institute	Phoenix	Arizona	United States	85044

Sponsors and Collaborators

LynxDx

Investigators

Principal Investigator: Pratik Patel, MD, Arizona State Urological Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LynxDx

ClinicalTrials.gov Identifier:

NCT05700370

Other Study ID Numbers:

Equivalency-Study-001

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by LynxDx

prostate-specific antigen

early detection of cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jan 26, 2023