Clinical trial NCT05910697: Clinical Utility of MyProstateScore 2.0 P2
Official title: An Extension Study of LynxDx's Ongoing Determination of Clinical Utility of MyProstateScore 2.0 Test: A Combined CPV-Based, Patient-Level Assessment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2023-06-20
Enrollment: 142
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Baseline levels of variation in the assessment, surveillance, and management of patients at high risk for prostate cancer among all study participants.
timeFrame: [9 months]
measure: 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).
timeFrame: [9 months]
measure: Differences in evidence-based decision making
timeFrame: [9 months]
measure: Differences in expected cost of care between control and intervention physicians.
timeFrame: [9 months]
measure: Differences in management of patients at risk of prostate cancer.
timeFrame: [9 months]
measure: Differences between expected quality of care and actual quality of care
timeFrame: [9 months]
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
References: