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Trial Title:
MyProstateScore Equivalency With and Without DRE
NCT ID:
NCT05700370
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
biomarker
tumor
prostate
prostatic neoplasm
prostate-specific antigen
early detection of cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
MyProstateScore
Description:
MyProstateScore is a urine-based biomarker test used to predict the risk of clinically
significant prostate cancer
Arm group label:
Sample collected with preceding DRE, then without
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.
Criteria for 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
Gender:
Male
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona State Urological Institute
Address:
City:
Phoenix
Zip:
85044
Country:
United States
Start date:
November 1, 2022
Completion date:
April 2023
Lead sponsor:
Agency:
LynxDx
Agency class:
Industry
Source:
LynxDx
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05700370
