MyProstateScore Equivalency With and Without DRE

LynxDx

Status: Invitation-only

Conditions: Prostate Cancer

Treatments: Diagnostic Test: MyProstateScore

Study type: Interventional

Funder types: Industry

Identifiers

NCT05700370

Equivalency-Study-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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800 participants in 1 patient group

Sample collected with preceding DRE, then without

Experimental group

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.

Treatment:

Diagnostic Test: MyProstateScore