Clinical Utility Study for MyProstateScore+

NCT05525806 | Completed

• 1 other identifier: Pro00065388
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• Clinical Performance and Value (CPV)-measured variation in Assessment

  Measuring the rates of ordering prostate biopsy with proper assessment, recognition, and management of prostate cancer risks in patients with different PSA levels, a negative previous prostate biopsy, and an elevated PI-RADS score.

  [4 months]

• CPV-measured change in treatment Quality

  Measure of the difference in quality of overall diagnostic scores between control physicians using standard of care diagnostic tools and intervention physicians using the MyProstateScore test.

  [4 months]

• CPV-measured variation in evidence based decisions between control and intervention arms

  Measure of the difference in number of evidence-based decisions made by intervention physicians versus control physicians, while controlling for physician and practice characteristics, between rounds 1 and 2.

  [4 months]

• CPV-measured variation in evidence based decisions between intervention arms

  Measure the differences in amount of evidence-based decisions made by intervention group one physicians versus intervention group two physicians to assess whether the choice to order the MyProstateScore test impacts the frequency of prostate biopsies and overall patient care and outcomes.

  [4 months]

• CPV-measured rate of adoption for MyProstateScore

  Rate of adoption of the MyProstateScore test after receiving educational materials on the benefits of testing in patients who are at risk.

  [4 months]

• CPV-measured differences in cost of care between control and intervention arms

  Difference in the cost of care between control and intervention physicians (Cost will be calculated by measuring differential rates of medical interventions/levels of care selected by each arm, and multiplying by Medicare reimbursement rates for these interventions, and/or by modeling the incidence of expected complications and calculating associated costs per above).

  [4 months]

Study Arms (3)

Control Group

NO INTERVENTION

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

Intervention Group 1

EXPERIMENTAL

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.

Other: Education Materials for MyProstateScore

Intervention Group 2

EXPERIMENTAL

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.

Other: Education Materials for MyProstateScore

Interventions

Education Materials for MyProstateScore 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.

Also known as: MyProstateScore results

Intervention Group 1; Intervention Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will enroll urologists practicing in the US. Participants are randomly assigned to either control, intervention 1, or intervention 2 arms upon enrollment. All eligible and consented participants will complete two rounds of three patient simulations. The intervention 1 and intervention 2 arms only will receive educational material about the LynxDx test in between these two rounds. Intervention 1 arm participants only will receive the CDMT test results whether they select it or not, and Intervention 2 participants will receive the CDMT test results only if they select it in the second round of simulated cases

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: September 2, 2022
• Study Start: September 12, 2022
• Primary Completion: June 4, 2023
• Study Completion: June 4, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

US (1)