Prostate CancerNCT04550416
Effects of a New Diagnostic Test on the Care of Prostate Cancer Patients: The ProMark™ Clinical Utility Study
A study testing ProMark Information and Test Results in people with Prostate Cancer, run by Qure Healthcare, LLC at 1 site in United States.
Trial summary
The objectives of this study are to assess clinical practice variation in prostate cancer diagnosis and treatment among urologists and how ProMark™ affects clinical practice decision-making. The study uses a randomized controlled study design of urologists. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ProMark Information and Test Results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2015
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provide consent to participate in the study
- Currently practicing board certified urologist
- Have practiced as a board-certified urologist for greater than 2 or less than 30 years.
- English-speaking
- Community / non-academic based practice setting
- ≥50 PCa patients under care annually
- Access to the internet
Who cannot join
- Not board certified in urology
- Academic based practice
- Have previously used ProMark for prostate cancer care delivery
- Have practiced as a board-certified urologist for less than 2 or greater than 30 years.
- Follow <50 PCa patients annually
- Non-English speaking
- Unable to access the internet
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to assess clinical practice variation in prostate cancer diagnosis and treatment among urologists and how ProMark™ affects clinical practice decision-making. The study uses a randomized controlled study design of urologists. Urologists will be randomly assigned to a control and intervention arm.
- Pre-intervention/baseline assessment: will be done using prostate cancer CPV® vignettes and a physician questionnaire to both control and intervention arms.
- Intervention: 2-4 weeks after baseline introduce ProMark™ to the intervention group of urologists using a protocol to be determined by Metamark and QURE.
- Post-intervention: 6 weeks post-intervention, a second round of prostate cancer CPV® vignettes will be administered to both control and intervention arms. The ProMark™ test will be available to "order" for all physicians taking the vignettes.
Read more
The Clinical Performance and Value Vignettes (CPV®) used in this study simulate a clinical encounter for a man presenting with prostate cancer. Each urologist will provide responses to open-ended questions regarding clinical care they would provide for that patient. These responses are scored in five domains (taking a medical history, performing a physical examination, ordering appropriate tests, making a diagnosis and prescribing treatment against explicit evidence and criteria as determined by the literature and medical associations. Results are presented as percentage correct. Each case will take approximately 15-20 minutes to complete. All case responses will be completed online and kept confidential.
The study hypotheses are:
- Clinical practice, specifically decisions around prostate cancer treatment post-diagnosis, will vary widely among urologists. This variation in practice will demonstrate the need a new diagnostic, such as ProMark™, would fulfill.
- ProMark™ will improve clinical decision making of urologists for prostate cancer patients with a Gleason Score of 3+3=6 and 3+4=7 by improving the diagnosis and/or treatment CPV® domain score post-intervention versus baseline comparing intervention and control groups
The investigators will estimate the effect of ProMark™ on the primary outcomes comparing treatment and control groups using a difference-in-difference analysis comparing differences between groups before and after intervention. The investigators will control for potential confounders, such as age, gender, and other physician and practice characteristics.
Read the detailed description
Secondary outcome measure include:
- Difference in overall Clinical Performance and Value Vignettes (CPV®) scores post-intervention versus baseline comparing intervention and control groups
- Difference between intervention and control for use of active surveillance.
- Change in utilization of resources in terms of surgery, radiation (in any form), chemotherapy (in any of its forms) between intervention and control groups.
- Conditions
- Prostate Cancer
- Being tested
- ProMark Information and Test Results
- Keywords
- prostate cancer, risk assessment, clinical utility
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProMark Information and Test ResultsOther
Participants in the intervention arm will receive information (both print and webinar format) about ProMark in between Round 1 and Round 2 data collection, as well as appropriate ProMark test results for each of the vignette-based simulated patients that they care for in the second round of data collection.
| Study group | Role | What they receive |
|---|---|---|
| ProMark Information and Results | Experimental | Participants in the intervention arm will receive information (both print and webinar format) about ProMark in between Round 1 and Round 2 data collection, as well as appropriate ProMark test results for each of the vignette-based simulated patients that they care for in the second round of data collection. Receives: Other: ProMark Information and Test Results |
| Standard Practice | No intervention | Physicians will care for online virtual patients as they normally would in practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined diagnostic and treatment CPV® (Clinical Performance and Value) vignette domain score
Difference in difference between the control and the intervention groups in the diagnosis-treatment quality of care as measured by their combined domain CPV scores (ranging from 0% to 100%) for the 9 patient types in aggregate and by case type.
Measured: 12 to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John W Peabody, MD PhD, Principal investigator, QURE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550416
- Sponsor's protocol ID
- 01-MM-14
- Status last verified
- Sep 2020
- First submitted
- 13 Jun 2014
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a New Diagnostic Test on the Care of Prostate Cancer Patients: The ProMark™ Clinical Utility Study
- ClinicalTrials.gov ID
- NCT04550416
- Acronym / sponsor ID
- 01-MM-14
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, risk assessment, clinical utility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Sep 2020 (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.
The objectives of this study are to assess clinical practice variation in prostate cancer diagnosis and treatment among urologists and how ProMark™ affects clinical practice decision-making. The study uses a randomized controlled study design of urologists. Urologists will be randomly assigned to a control and intervention arm.
- Pre-intervention/baseline assessment: will be done using prostate cancer CPV® vignettes and a physician questionnaire to both control and intervention arms.
- Intervention: 2-4 weeks after baseline introduce ProMark™ to the intervention group of urologists using a protocol to be determined by Metamark and QURE.
- Post-intervention: 6 weeks post-intervention, a second round of prostate cancer CPV® vignettes will be administered to both control and intervention arms. The ProMark™ test will be available to "order" for all physicians taking the vignettes.
The Clinical Performance and Value Vignettes (CPV®) used in this study simulate a clinical encounter for a man presenting with prostate cancer. Each urologist will provide responses to open-ended questions regarding clinical care they would provide for that patient. These responses are scored in five domains (taking a medical history, performing a physical examination, ordering appropriate tests, making a diagnosis and prescribing treatment against explicit evidence and criteria as determined by the literature and medical associations. Results are presented as percentage correct. Each case will take approximately 15-20 minutes to complete. All case responses will be completed online and kept confidential.
The study hypotheses are:
- Clinical practice, specifically decisions around prostate cancer treatment post-diagnosis, will vary widely among urologists. This variation in practice will demonstrate the need a new diagnostic, such as ProMark™, would fulfill.
- ProMark™ will improve clinical decision making of urologists for prostate cancer patients with a Gleason Score of 3+3=6 and 3+4=7 by improving the diagnosis and/or treatment CPV® domain score post-intervention versus baseline comparing intervention and control groups
The investigators will estimate the effect of ProMark™ on the primary outcomes comparing treatment and control groups using a difference-in-difference analysis comparing differences between groups before and after intervention. The investigators will control for potential confounders, such as age, gender, and other physician and practice characteristics.
Detailed description
Secondary outcome measure include:
- Difference in overall Clinical Performance and Value Vignettes (CPV®) scores post-intervention versus baseline comparing intervention and control groups
- Difference between intervention and control for use of active surveillance.
- Change in utilization of resources in terms of surgery, radiation (in any form), chemotherapy (in any of its forms) between intervention and control groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProMark Information and Results | Experimental | Other: ProMark Information and Test ResultsParticipants in the intervention arm will receive information (both print and webinar format) about ProMark in between Round 1 and Round 2 data collection, as well as appropriate ProMark test results for each of the vignette-based simulated patients that they care for in the second round of data collection. |
| Standard Practice | No intervention | –Physicians will care for online virtual patients as they normally would in practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Provide consent to participate in the study
- Currently practicing board certified urologist
- Have practiced as a board-certified urologist for greater than 2 or less than 30 years.
- English-speaking
- Community / non-academic based practice setting
Key exclusion criteria (7 listed)
- Not board certified in urology
- Academic based practice
- Have previously used ProMark for prostate cancer care delivery
- Have practiced as a board-certified urologist for less than 2 or greater than 30 years.
- Follow <50 PCa patients annually
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 |
|---|---|---|
| ProMark Information and Test ResultsParticipants in the intervention arm will receive information (both print and webinar format) about ProMark in between Round 1 and Round 2 data collection, as well as appropriate ProMark test results for each of the vignette-based simulated patients that they care for in the second round of data collection. | Other | ProMark Information and Results |
Primary outcome
Combined diagnostic and treatment CPV® (Clinical Performance and Value) vignette domain score
Time frame: 12 to 16 weeks
Difference in difference between the control and the intervention groups in the diagnosis-treatment quality of care as measured by their combined domain CPV scores (ranging from 0% to 100%) for the 9 patient types in aggregate and by case type.
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 16 Sep 2020.
- Study Sponsor web pageLink provided by the sponsor.
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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.
John W Peabody, MD PhD principal investigator
QURE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProMark Information and Test 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 7 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 16 Sep 2020. 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?
Combined diagnostic and treatment CPV® (Clinical Performance and Value) vignette domain score (time frame: 12 to 16 weeks). 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 16 Sep 2020.