Clinical Utility of MyProstateScore 2.0 P2

NCT ID: NCT05910697

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2023-10-18

Brief Summary

This is an extension of an ongoing study. Preliminary results from the ongoing study indicate that the MyProstateScore 2.0 (MPS 2.0) Test is significantly improving early diagnosis of prostate cancer. This extension will allow us to ask the study participants in the ongoing study to share patient-level data for chart abstraction. The specific purpose of this study is to generate high-quality real-world data on the clinical utility of LynxDx's new MPS 2.0 test.

Detailed Description

The results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidelines. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 150 physicians.

Upon consenting and agreeing to participate in this study, participants will be asked to care for 3 simulated patient cases, known as Clinical Performance and Value Vignettes (CPV®). CPVs describe patients physicians typically encounter in their daily practice and are not meant to be difficult. In each vignette, physicians are asked to share their expected care through 5 domains: 1) history, 2) physical exam, 3) diagnostic workup, 4) diagnosis, and 5) treatment and follow-up. Each case takes approximately 15-20 minutes to complete and the investigators estimate the time commitment for each round of CPV administration to be approximately 45 - 60 minutes. All responses to the cases will be completed online and will be kept confidential. They will also be asked to submit de-identified charts for patients who meet eligibility criteria.

Physicians will keep their randomization from the ongoing study, and intervention physicians will have the opportunity to order a diagnostic test for their patients free of charge.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control arm - Baseline comparison

The Control group treats their simulated patients using standard practice and has no introduction to the new MyProststate 2.0 test.

Group Type: NO_INTERVENTION

No interventions assigned to this group

MyProstateScore 2.0

The intervention will receive information regarding the MyProstateScore 2.0 test and will be given the test results in their round of CPV information and for each sample that they submit.

Group Type: EXPERIMENTAL

MyProstateScore 2.0 Results

Intervention Type: OTHER

Being shown the results of a diagnostic test for the likelihood of finding clinically significant cancer from a prostate biopsy and how it changes clinical practice.

Interventions

MyProstateScore 2.0 Results

Being shown the results of a diagnostic test for the likelihood of finding clinically significant cancer from a prostate biopsy and how it changes clinical practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Licensed urologist
• Have practiced as a urologist for greater than 2 but less than 40 years
• Commonly treats patients at risk for prostate cancer
• Practicing in the United States
• English-speaking
• Access to the internet
• Informed and voluntarily consented to be in the study

Exclusion Criteria

• Non-English speaking
• Not a licensed primary care provider
• Unable to access the internet
• Not practicing in the U.S.
• Do not voluntarily consent to be in the study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qure Healthcare, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

QURE Healthcare

San Francisco, California, United States

Countries

United States

Other Identifiers

Pro00070241

Identifier Type: -

Identifier Source: org_study_id