Clinical Utility Study for MyProstateScore+

NCT ID: NCT05525806

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2023-06-04

Brief Summary

This is a national-level research study of urologists. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.

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 guidance. The data from this study will be submitted to a national journal for publication. The study plans to enroll up to 250 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 we 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. Over 2 CPV administration rounds, the total time to care for the simulated patients is estimated at 1.5-2 hours.

If physicians are randomized to an intervention group in this study, they will receive education materials on a novel diagnostic test after the first round of CPV administration. They are asked to review these materials before moving to the next CPV administration round. Time to review education materials is estimated to be approximately 15 minutes.

Depending on the results of this randomized controlled trial, there may be an opportunity for physicians to re-enroll into a follow-on study. If they choose to participate in this second study, they will be asked to identify and send de-identified records of patients in their practice that are similar to the simulated patients they previously cared for in this study.

Conditions

Prostate Cancer

Study Design

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

Study Groups

Control Group

Control group treats their simulated patients using standard practice and have no introduction to the new LynxDx test.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group 1

Intervention Group 1 will receive information regarding the LynxDx rest and will be given the test results, whether selected or not, in Round 2 of CPV administration.

Group Type: EXPERIMENTAL

Education Materials for MyProstateScore

Intervention Type: OTHER

These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.

Intervention Group 2

Intervention Group 2 will receive information regarding the LynxDx test and will be given the test results if selected in Round 2 of CPV administration.

Group Type: EXPERIMENTAL

Education Materials for MyProstateScore

Intervention Type: OTHER

These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.

Interventions

Education Materials for MyProstateScore

These materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report.

Intervention Type: OTHER

Other Intervention Names

MyProstateScore results

Eligibility Criteria

Inclusion Criteria

• Board-certified urologists for at least two years
• Averaging at least 20 hours per week of clinical and patient care duties over the last six months
• Routinely evaluate patients at risk for prostate cancer in their practice
• Practicing in the U.S.
• English speaking
• Access to the internet
• Informed, signed and voluntarily consented to be in the study

Exclusion Criteria

• Non-English speaking
• Unable to access the internet
• Not practicing in the U.S.
• Not averaging at least 20 hours per week of clinical or patient care duties over the last six months
• Previous exposure to the MyProstateScore test
• 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

Pro00065388

Identifier Type: -

Identifier Source: org_study_id