Prostate CancerNCT05700370
MyProstateScore Equivalency With and Without DRE
A study testing MyProstateScore in people with Prostate Cancer, run by LynxDx at 1 site in United States.
Trial summary
The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MyProstateScore
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Apr 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a candidate for prostate biopsy (Bx)
- If Bx naïve and ≤75yo then PSA 3-10 ng/mL
- If Bx naïve and >75yo then PSA 4-10 ng/mL
- If prior negative Bx then PSA may exceed 10 ng/mL
- If DRE very suspicious, then PSA below the thresholds of 3 ng/mL (≤75yo) and 4 ng/mL (>75yo) are acceptable
Who cannot join
- Prior diagnosis of prostate cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona State Urological Institute
Phoenix, Arizona, 85044
About this study
Official title: Equivalency of MyProstateScore (MPS) Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination
The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE.
Read the detailed description
The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE. In order to do so, we will perform a crossover study in which each subject provides a sample under both conditions.
- Conditions
- Prostate Cancer
- Being tested
- MyProstateScore
- Keywords
- biomarker, tumor, prostate, prostatic neoplasm, prostate-specific antigen, early detection of cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyProstateScoreDiagnostic test
MyProstateScore is a urine-based biomarker test used to predict the risk of clinically significant prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Sample collected with preceding DRE, then without | Experimental | All subjects participate in the control and experimental collection event sequentially. The control group will consist of urine samples collected post-DRE, and the experimental group will consist of urine samples collected by the same subjects without preceding DRE. Receives: Diagnostic Test: MyProstateScore |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPS equivalency with and without DRE
The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE.
Measured: Study participation will span 8 days
MPS validity rate with and without DRE
Rate of invalid test result equivalency in post-DRE versus non-DRE paired urine samples. Rate will be measured as the percentage of subjects who return an invalid urine sample.
Measured: Study participation will span 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Nov 2022
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LynxDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pratik Patel, MD, Principal investigator, Arizona State Urological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700370
- Sponsor's protocol ID
- Equivalency-Study-001
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: MPS results from the post-DRE urine sample will be reported to the provider, consistent with current commercially available processes. Results from the experimental sample collected without a preceding DRE will not be reported to the subject or their provider.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalency of MyProstateScore (MPS) Results Between Urine Samples Collected With or Without a Preceding Digital Rectal Examination
- ClinicalTrials.gov ID
- NCT05700370
- Acronym / sponsor ID
- Equivalency-Study-001
- Conditions
- Prostate Cancer
- Keywords
- biomarker, tumor, prostate, prostatic neoplasm, prostate-specific antigen, early detection of cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- LynxDxIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 26 Jan 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.
The purpose of the study is to quantify the concordance of MPS results between first-catch urine samples collected post-DRE and those collected without a DRE.
Detailed description
The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE. In order to do so, we will perform a crossover study in which each subject provides a sample under both conditions.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample collected with preceding DRE, then without | Experimental | Diagnostic Test: MyProstateScoreAll subjects participate in the control and experimental collection event sequentially. The control group will consist of urine samples collected post-DRE, and the experimental group will consist of urine samples collected by the same subjects without preceding DRE. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is a candidate for prostate biopsy (Bx)
- If Bx naïve and ≤75yo then PSA 3-10 ng/mL
- If Bx naïve and >75yo then PSA 4-10 ng/mL
- If prior negative Bx then PSA may exceed 10 ng/mL
- If DRE very suspicious, then PSA below the thresholds of 3 ng/mL (≤75yo) and 4 ng/mL (>75yo) are acceptable
Key exclusion criteria (1 listed)
- Prior diagnosis of prostate cancer
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 |
|---|---|---|
| MyProstateScoreMyProstateScore is a urine-based biomarker test used to predict the risk of clinically significant prostate cancer | Diagnostic test | Sample collected with preceding DRE, then without |
Primary outcome
MPS equivalency with and without DRE
Time frame: Study participation will span 8 days
The process for obtaining a urine sample for MPS currently requires a DRE within one hour prior to urine collection. We aim to understand whether a DRE is a required step prior to urine collection for MPS, and to explore alternative methods that may eliminate the need for a DRE.
MPS validity rate with and without DRE
Time frame: Study participation will span 8 days
Rate of invalid test result equivalency in post-DRE versus non-DRE paired urine samples. Rate will be measured as the percentage of subjects who return an invalid urine sample.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: Yes. MPS results from the post-DRE urine sample will be reported to the provider, consistent with current commercially available processes. Results from the experimental sample collected without a preceding DRE will not be reported to the subject or their provider.
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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.
Pratik Patel, MD principal investigator
Arizona State Urological Institute
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 in people with Prostate Cancer, run by LynxDx 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 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?
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?
MPS equivalency with and without DRE (time frame: Study participation will span 8 days). The study lists 2 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 26 Jan 2023.