Back to resultsMyProstateScore Equivalency With and Without DRE
Primary Purpose
Prostate Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyProstateScore
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer focused on measuring biomarker, tumor, prostate, prostatic neoplasm, prostate-specific antigen, early detection of cancer
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
Sites / Locations
- Arizona State Urological Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sample collected with preceding DRE, then without
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05700370
Brief Title
MyProstateScore Equivalency With and Without DRE
Official Title
Equivalency of MyProstateScore (MPS) Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LynxDx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
biomarker, tumor, prostate, prostatic neoplasm, prostate-specific antigen, early detection of cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sample collected with preceding DRE, then without
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MyProstateScore
Intervention Description
MyProstateScore is a urine-based biomarker test used to predict the risk of clinically significant prostate cancer
Primary Outcome Measure Information:
Title
MPS equivalency with and without 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.
Time Frame
Study participation will span 8 days
Title
MPS validity rate with and without DRE
Description
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.
Time Frame
Study participation will span 8 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pratik Patel, MD
Organizational Affiliation
Arizona State Urological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State Urological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
MPS results from the post-DRE urine sample will be reported to the provider, consistent with current commercially available processes. Results from the experimental sample collected without a preceding DRE will not be reported to the subject or their provider.
IPD Sharing Time Frame
In accordance with the commercially available process
IPD Sharing Access Criteria
In accordance with the commercially available process
Learn more about this trial
MyProstateScore Equivalency With and Without DRE
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