Prostate CancerNCT05525806
Clinical Utility Study for MyProstateScore+
A study testing Education Materials for MyProstateScore in people with Prostate Cancer, run by Qure Healthcare, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Education Materials for MyProstateScore
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 4 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for LynxDx's MyProstateScore Test: A CPV® Randomized Controlled Trial
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.
Read the 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
- Being tested
- Education Materials for MyProstateScore
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education Materials for MyProstateScoreOther
Also called MyProstateScore results
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Education Materials for MyProstateScore |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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.
Measured: [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.
Measured: [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.
Measured: [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.
Measured: [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).
Measured: [4 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start12 Sep 2022
- Primary completion4 Jun 2023
- Study completion4 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525806
- Sponsor's protocol ID
- Pro00065388
- Status last verified
- Jun 2023
- First submitted
- 22 Aug 2022
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Clinical Utility Evidence to Support Coverage and Reimbursement for LynxDx's MyProstateScore Test: A CPV® Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05525806
- Acronym / sponsor ID
- Pro00065388
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 4 Jun 2023 (actual)
- Study completion
- 4 Jun 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Education Materials for MyProstateScoreIntervention 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. |
| Intervention Group 2 | Experimental | Other: Education Materials for MyProstateScoreIntervention Group 2 will receive information regarding the LynxDx test and will be given the test results if selected in Round 2 of CPV administration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education Materials for MyProstateScoreAlso: MyProstateScore resultsThese materials detail what the test does, how it is used, the validity and specifications of the test, and how to read its test report. | Other | Intervention Group 1, Intervention Group 2 |
Primary outcome
Clinical Performance and Value (CPV)-measured variation in Assessment
Time frame: [4 months]
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.
CPV-measured change in treatment Quality
Time frame: [4 months]
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.
CPV-measured variation in evidence based decisions between control and intervention arms
Time frame: [4 months]
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.
CPV-measured variation in evidence based decisions between intervention arms
Time frame: [4 months]
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.
CPV-measured rate of adoption for MyProstateScore
Time frame: [4 months]
Rate of adoption of the MyProstateScore test after receiving educational materials on the benefits of testing in patients who are at risk.
CPV-measured differences in cost of care between control and intervention arms
Time frame: [4 months]
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Materials for MyProstateScore in people with Prostate Cancer, run by Qure Healthcare, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance and Value (CPV)-measured variation in Assessment (time frame: [4 months]). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.