Clinical Utility of MyProstateScore 2.0 P2

NCT05910697 | Terminated

• 1 other identifier: Pro00070241
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• Baseline levels of variation in the assessment, surveillance, and management of patients at high risk for prostate cancer among all study participants.

  Using the responses of the CPV cases as well as abstracted chart data to measure the baseline levels of variation in the work-up, recognition, and management of prostate cancer. Work-up, recognition, and management scores will be combined to report variation in total assessment of the simulated patient cases.

  [9 months]

• Pre- and post-comparison of overall diagnostic and treatment scores between Control physicians (using standard of care diagnostic tools) and Intervention physicians (with access to the MyProstateScore 2.0 test).

  Measure of overall CPV scores between arms using standard of care measurements between the control and intervention arms.

  [9 months]

• Differences in evidence-based decision making

  Differences in the number of evidence-based decisions made by intervention physicians versus control physicians (such as prescribing pharmaceuticals or non-pharmacologic interventions), while statistically controlling for physician and practice characteristics, between rounds 1 and 2.

  [9 months]

• Differences in expected cost of care between control and intervention physicians.

  Difference in the cost of care between control and intervention participants (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).

  [9 months]

• Differences in management of patients at risk of prostate cancer.

  Differences between control and intervention patients in the quality of counseling, utilization of biopsies/scheduled biopsies, referrals, imaging studies, and reported symptoms. As measured by the number of times each item is seen in the collected data.

  [9 months]

• Differences between expected quality of care and actual quality of care

  Measure any discrepancy in clinical quality metrics and by different use case types. Measured by number of evidence-based decisions seen in medical chart abstraction.

  [9 months]

Study Arms (2)

Control arm - Baseline comparison

NO INTERVENTION

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

MyProstateScore 2.0

EXPERIMENTAL

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.

Other: MyProstateScore 2.0 Results

Interventions

MyProstateScore 2.0 Results 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.

MyProstateScore 2.0

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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: Physicians who were enrolled in the ongoing study will keep their arm assignments. Intervention physicians will have access to educational materials as well as a diagnostic test.

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: June 20, 2023
• Study Start: March 31, 2023
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)