Prostate CancerNCT05910697
Clinical Utility of MyProstateScore 2.0 P2
A study testing MyProstateScore 2.0 Results in people with Prostate Cancer, run by Qure Healthcare, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MyProstateScore 2.0 Results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 18 Oct 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
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 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.
- Conditions
- Prostate Cancer
- Being tested
- MyProstateScore 2.0 Results
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyProstateScore 2.0 ResultsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MyProstateScore 2.0 Results |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: [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.
Measured: [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.
Measured: [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).
Measured: [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.
Measured: [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.
Measured: [9 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start31 Mar 2023
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Why it stopped: The decision to stop the study was made by the sponsor, based solely on timeline constraints.
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
- 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.
- Masking
- None (open label)
- Enrolment
- 142 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
- NCT05910697
- Sponsor's protocol ID
- Pro00070241
- Status last verified
- Nov 2023
- First submitted
- 31 Mar 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05910697
- Acronym / sponsor ID
- Pro00070241
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to stop the study was made by the sponsor, based solely on timeline constraints.
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 20 Jun 2023 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: MyProstateScore 2.0 ResultsThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| MyProstateScore 2.0 ResultsBeing 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. | Other | MyProstateScore 2.0 |
Primary outcome
Baseline levels of variation in the assessment, surveillance, and management of patients at high risk for prostate cancer among all study participants.
Time frame: [9 months]
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.
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).
Time frame: [9 months]
Measure of overall CPV scores between arms using standard of care measurements between the control and intervention arms.
Differences in evidence-based decision making
Time frame: [9 months]
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.
Differences in expected cost of care between control and intervention physicians.
Time frame: [9 months]
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).
Differences in management of patients at risk of prostate cancer.
Time frame: [9 months]
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.
Differences between expected quality of care and actual quality of care
Time frame: [9 months]
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.
Results and safety
The study was stopped early (reason given: The decision to stop the study was made by the sponsor, based solely on timeline constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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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 MyProstateScore 2.0 Results 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 5 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: stopped early, as of the sponsor's last update on 15 Nov 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 was stopped early (reason given: The decision to stop the study was made by the sponsor, based solely on timeline constraints.). Results are not available in the source record.
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?
Baseline levels of variation in the assessment, surveillance, and management of patients at high risk for prostate cancer among all study participants. (time frame: [9 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 15 Nov 2023.